News 10/19/18

Top News

The FDA updates draft guidance on managing cybersecurity issues for the premarket submission of medical devices. FDA Commissioner Scott Gottlieb, MD says the document, initially penned in 2014, offers “recommendations for manufacturers on how they can better protect their products against different cybersecurity risks, from ransomware to a catastrophic attack on a health system.”

HIStalk Announcements and Requests

I don’t pay much attention to the “Like” button at the bottom of each HIStalk post, but did happen to notice that Alexander Scarlat’s first Readers Write installment on machine learning had already garnered several dozen clicks. It hasn’t quite gained the notoriety of the most popular post in recent memory, which deals with remedying poor clinician engagement with health IT. Both tap into several pieces of advice I give those interested in submitting editorial:

1. Readers will give your content more credence if you write from a place of experience. Both authors of the aforementioned posts have MDs, and other in-the-trenches educational and professional experience to back up their right to editorialize. Vendor authors – unless they too have immense clinical chops – will never quite escape the subconscious bias of readers who see a company name in the byline and immediately worry their time is being wasted by someone trying to sell them something.

2. Of-the-moment topics written for an audience with significant experience working in the health IT trenches are key to a good read, and will often sustain relevance for some time. Submissions that offer a 1,000-foot view rather than diving into the nitty gritty will attract critics who aren’t afraid to lambast authors. (Granted, I try to filter those out, but some slip through.)

3. Pop culture and humor are always good bets, provided they are in good taste. (I’m still shaking my head at the submission sent over with a curse word in the headline.) I often point interested parties to the “All I Needed to Know to Disrupt Healthcare I Learned from ‘Seinfeld’” series penned in 2015 by Bruce Bandes as a great example of original, humorous content that speaks to a timely topic.

Webinars

October 30 (Tuesday) 2:00 ET. “How One Pediatric CIN Aligned Culture, Technology and the Community to Transform Care.” Presenters: Lisa Henderson, executive director, Dayton Children’s Health Partners; Shehzad Saeed, MD, associate chief medical officer, Dayton Children’s Health Partners; Mason Beard, solutions strategy leader, Philips PHM; Gabe Orthous, value-based care consultant, Himformatics. Sponsor: Philips PHM. Dayton Children’s Health Partners, a pediatric clinically integrated network, will describe how it aligned its internal culture, technology partners, and the community around its goal of streamlining care delivery and improving outcomes. Presenters will describe how it recruited network members, negotiated value-based contracts, and implemented a data-driven care management process.

Previous webinars are on our YouTube channel. Contact Lorre for information.

Acquisitions, Funding, Business, and Stock

Gauss Surgical raises $20 million in a Series C funding round led by Northwell Health (NY) and SoftBank Ventures Korea, with help from seven other health systems. Funding thus far comes to $52 million. The company has developed tablet-based software that uses machine learning and digital imaging to monitor maternal surgical blood loss in real time.

Digital prescription savings company OptimizeRx acquires interactive patient messaging vendor CareSpeak Communications for an undisclosed amount.

Muscular dystrophy nonprofit CureDuchenne invests in ZappRx, and will help the vendor optimize its e-prescribing and electronic prior authorization software for Duchenne patients.

23andMe CEO Anne Wojcicki tells Rock Health conference attendees that she hopes to soon roll out a test that will help consumers better understand how their bodies react to certain antidepressants. Price points for similar services offered by Color Genomics and Albertsons grocery store pharmacists range from $250 to $750. The FDA shut down 23andMe’s first attempt at such a test in 2013 based on the fear that consumers could misinterpret the results as medical advice.

People

Patrick Flavin (Outcome Health) joins Arches Technology as president.

HCTec names Salome Isbell (MedHOK) CFO, Victor Ayers (Infor) VP of professional services, and Heather Espino (Centura Health) VP of clinical solutions.

Announcements and Implementations

Bassett Medical Center (NY) adopts Masimo’s Patient SafetyNet and Root with Vital Signs Check across its 54-bed med-surg unit.

Massachusetts EHealth Collaborative and Cognizant will provide technical and financial consulting services to the MassHealth Delivery System Reform Incentive Payment technical assistance program’s ACOs and community partners.

Partners Connected Health adds a mobile app to its PGHDConnect program, giving users the ability to securely share health data with their providers from 250 devices.

Government and Politics

The FDA and Department of Homeland Security announce they will work together to share information on cybersecurity vulnerabilities in medical devices so that threats to patient safety can be addressed more quickly.

Privacy and Security

Following a similar GDPR-induced move in Europe, Apple gives US users the ability to view, edit, and delete data it has collected on them using a new tool on its privacy website. The tool does not apply to data collected by and stored on Apple devices, including biometric data like fingerprints and heart rates.

Other

The Sequoia Project creates the Interoperability Matters Advisory Group and solicits nominations for workgroup members who will provide feedback and recommendations on interoperability endeavors. I was not aware that Sequoia relinquished Carequality earlier this month to operate as a standalone entity.

In Dublin, St. James’s Hospital goes live on expanded Cerner functionality, making it the largest EHR implementation in Ireland’s history. The three-year project was dubbed “Project Oak” as an homage to the paper the Millenium conversion will save.

Vermont Information Technology Leaders struggles to pare down the number of duplicate patient records in the state’s HIE. An audit last year found 1.7 million unique records for 624,000 residents and patients from out of town. VITL staff have deemed at least 35 percent of those to be duplicates, and hope to have that number down to 21 percent by the end of the year. The struggle for a unique patient identifier in the Green Mountain State is real.

Sponsor Updates

• EClinicalWorks will exhibit at CHCANYS18 Annual Conference and Clinical Forum October 21-23 in Tarrytown, NY.
• FormFast will host virtual user group meetings October 23 and 24.
• Healthwise will exhibit at the 2018 PNEG Conference October 19-21 in Fort Wayne, IN.
• Foundations Health Solutions wins an Excellence in Technology Award from McKnight’s for its use of Hyland OnBase.
• Formativ Health adds Conversa Health’s AI-powered chatbot messaging tool to its line of patient engagement services.
• Imprivata completes the Zebra Technologies Validated Program for its Mobile Device Access.
• Casenet becomes a founding member of the private-sector Da Vinci project, which aims to leverage FHIR to improve data-sharing in value-based care arrangements.
• ZeOmega adds MCG Health’s Cite AutoAuth prior authorization software to its Jiva population health management technology.
• HCTec publishes a new case study featuring Montefiore Health System.
• NHS approves Elsevier as a supplier for its NHS England Health Systems Support Framework.

Blog Posts

• How telehealth helps to improve compliance among ADHD patients (EClinicalWorks)
• Automatically Map, Visualize and Troubleshoot Your Citrix Infrastructure with Topology View (Goliath Technologies)
• Thoughts on mentoring (Hyland)
• New ‘Reference Architecture’ Guide Helps Customers Implement Imprivata OneSign Single Sign-On with Epic Systems (Imprivata)
• Streamline Healthcare CRM Implementation with a Cross-Functional Team (Influence Health)
• Northwell Health: Unifying Patient Records as Our Organization Expands (InterSystems)
• How Hospital for Special Surgery Positions its Referral Center to Unlock Access & Boost Patient Satisfaction (Kyruus)
• Reducing Errors from Look-Alike, Sound-Alike Medication Names: The Role of Indications (FDB)

Contacts

Mr. H, Lorre, Jenn, Dr. Jayne.
Get HIStalk updates. Send news or rumors.
Contact us.

EPtalk with Dr. Jayne 10/18/18

A reader recently asked how/where I keep my own personal medical records. I may have written about it in the past, but my strategy is always evolving, so I’ll share my answer. From my college and medical school days, I have a few paper documents, mostly pathology reports printed from our hospital’s HIM system, and an original vaccination record from our student health clinic. The vaccinations I also keep as a PDF, which becomes useful when I have to turn in my annual health form to volunteer at a youth summer camp. I always chuckle when I have to transfer that data, because I received my last two non-influenza vaccinations (Hepatitis A and Tdap) only because my staff mistakenly drew up doses that were going to have to go to waste, so I had them “waste” the vaccine into my left deltoid.

Beyond that, I have a thumb drive with my entire OB/GYN medical record, provided to me by my physician when she closed her practice. I’m pretty sure it’s not encrypted, and I’ve summarized the important parts into a Word document. I used to have an account on a commercial patient health record courtesy of my employer, but it was clunky and cumbersome, and frankly just creating my own word document was more useful. My genetic counseling records are all on paper, given to me at the end of my visit by my counselor. Her office does not store records electronically or communicate via patient portal. It’s very old-school. When my local health system began their conversion to Epic last year, I did download all my records from their portal, storing them as PDFs on my OneDrive. That way, I can access them from anywhere should I need them. I also store copies of my living will and healthcare power of attorney on the OneDrive, because I’ve seen too many bad things happen and I trot those documents out as needed.

It’s not an elegant solution, but as a physician I have a pretty good handle on my health status and can quickly put my fingers on the data I need even, if it’s not very well organized or categorized. I’m relatively young and healthy, so I don’t have a lot of records to track. I love the idea of patients having their own curated records that they can share, but that concept still scares a lot of physicians silly. I’ve seen some really good solutions on the market, but there hasn’t really been a lot of traction with patients, even with Apple on the scene. I do have an iBlueButton account with Humetrix, although I haven’t used it in a while. Hopefully I’ll stay healthy with no additional data to add.

Speaking of staying healthy, many of us in clinical informatics pride ourselves on delivering evidence-based care using robust clinical decision support tools. Still, the last mile in making evidence-based care a reality is often the conversation between the clinician, his or her staff, and the patient. During this year’s influenza vaccination season, we’re seeing patients who are resistant to the vaccine because of the perception that it was ineffective last year. This is borne out in a recent survey by Stericycle, which notes that a third of US respondents don’t plan to get a flu shot this year. Last year, influenza killed more than 80,000 people, but the data doesn’t appear to sway these folks. My staff has practiced and role-played various talk-tracks for patients, so we’ll have to see if we can continue to convince our patients that it’s the right thing to do. For certain, we’ll be getting an EHR-delivered score card at the end, so every vaccination counts.

I recently learned about the Neighborhood Navigator tool, released by the EveryONE Project in partnership with the American Academy of Family Physicians. The tool uses more than 100 languages and integrates with Google Maps to help patients find directions and connect with social services for needs such as food, housing, transportation, employment, legal services, and more. There is a set of training videos for physicians to help them understand the tool and how to best refer patients.

My colleagues in the physician lounge often lament the changes in healthcare brought on by the growing presence of the Internet and the rise of social media in everyday life. Data from recent surveys reveals some interesting statistics: 54 percent of millennials (and 42 percent of all adults) have either “friended” their provider on social media or would like to do so; 65 percent of millennials (and 43 percent of all adults) find social media appropriate to use to contact their provider about a health issue; and 32 percent of those surveyed have taken a health-related action as a result of information they read on social media.

I stumbled across the “Shots by AAFP/STFM” app in the Google Play store. It includes full CDC vaccine schedules and footnotes, as well as dosing information, contraindications, and catch-up schedule information for all available vaccines. Content is written by immunization experts at the Society of Teachers of Family Medicine. You can also enter a patient’s age and various parameters to get a recommendation on what vaccinations are needed. I use multiple resources in trying to figure out vaccine schedules for people, so I’m looking forward to giving this a try to see if it will be my new one-stop-shop. It’s also available on iTunes.

My slow day in the clinic allowed for a lot of Web surfing in between studying for boards, and I also stumbled upon ePrognosis from University of California, San Francisco. The site’s goal is “to be a repository of published geriatric prognostic indices where clinicians can go to obtain evidence-based information on patients’ prognosis.” I ran the profiles of my favorite community-living nonagenarians, and it looks like the odds of them continuing to do well are very good indeed.

Working at an urgent care that also provides occupational medicine services, we see a number of patients who come in for drug screens. Many employers require these to be observed drug screens, so that there is no question of an employee substituting someone else’s urine sample. I chuckled when I saw this feature on a Florida convenience store that has had to put up a sign telling users not to microwave urine samples. Even our drug screens that are not observed include taking the temperature of the sample to make sure it’s within a valid physiological range, so if someone were going to try to microwave it, they’d have to get it just right. Still, it makes one think twice about using a public microwave.

Email Dr. Jayne.

Morning Headlines 10/18/18

OptimizeRx Acquires CareSpeak Communications

Digital prescription savings company OptimizeRx acquires interactive patient messaging vendor CareSpeak Communications for an undisclosed sum.

Apple gives U.S. users tool to see what data it has collected

Following a similar GDPR-induced move in Europe, Apple gives US users the ability to view, edit, and delete the data it has collected on them.

Sequoia Project Launches Interoperability Matters Forum

The Sequoia Project creates the Interoperability Matters Advisory Group and solicits nominations for workgroup members who will provide feedback and recommendations on interoperability endeavors.

A Machine Learning Primer for Clinicians–Part 1

Alexander Scarlat, MD is a physician and data scientist, board-certified in anesthesiology with a degree in computer sciences. He has a keen interest in machine learning applications in healthcare. He welcomes feedback on this series at drscarlat@gmail.com.

AI State of the Art in 2018

Near human or super-human performance:

• Image classification
• Speech recognition
• Handwriting transcription
• Machine translation
• Text-to-speech conversion
• Autonomous driving
• Digital assistants capable of conversation
• Go and chess games
• Music, picture, and text generation

Considering all the above — AI/ML (machine learning), predictive analytics, computer vision, text and speech analysis — you may wonder:

How can a machine possibly learn?!

As a physician with a degree in CS and curious about ML, I took the ML Stanford/Coursera course by Andrew Ng. It was a painful, but at the same time an immensely pleasurable educational experience. Painful because of the non-trivial math involved. Immensely pleasurable because I’ve finally understood how a machine actually learns.

If you are a clinician who is interested in AI / ML but short on math / programming skills or time, I will try to clarify in a series of short articles — under the gracious auspices of HIStalk — what I have learned from my short personal journey in ML. You can check some of my ML projects here.

I promise that no math or programming are required.

Rules-Based Systems

The ancient predecessors of ML are rules-based systems. They are easy to explain to humans:

• IF the blood pressure is between normal and normal +/- 25 percent
• AND the heart rate is between normal and normal + 27 percent
• AND the urinary output is between normal and normal – 43 percent
• AND / OR etc.
• THEN consider septic shock as part of the differential diagnosis.

The problem with these systems is that they are time-consuming, error-prone, difficult and expensive to build and test, and do not perform well in real life.

Rules-based systems also do not adapt to new situations that the model has never seen.

Even when rules-based systems predict something, it is based on a human-derived rule, on a human’s (limited?) understanding of the problem and how well that human represented the restrictions in the rules-based system.

One can argue about the statistical validation that is behind each and every parameter in the above short example rule. You can imagine what will happen with a truly big, complex system with thousands or millions of rules.

Rules-based systems are founded on a delicate and very brittle process that doesn’t scale well to complex medical problems.

ML Definitions

Two definitions of machine learning are widely used:

• “The field of study that gives computers the ability to learn without being explicitly programmed.” (Arthur Samuel).
• “A computer program is said to learn from experience (E) with respect to some class of tasks (T) and performance measure (P) — IF its performance at tasks in T, as measured by P, improves with experience E.” (Tom Mitchell).

Rules-based systems, therefore are by definition NOT an ML model. They are explicitly programmed according to some fixed, hard-wired set of finite rules

With any model, ML or not ML, or any other common sense approach to a task, one MUST measure the model performance. How good are the model predictions when compared to real life? The distance between the model predictions and the real-life data is being measured with a metric, such as accuracy or mean-squared error.

A true ML model MUST learn with each and every new experience and improve its performance with each learning step while using an optimization and loss function to calibrate its own model weights. Monitoring and fine-tuning the learning process is an important part of training a ML algorithm.

What’s the Difference Between ML and Statistics?

While ML and statistics share a similar background and use similar terms and basic methods like accuracy, precision, recall, etc., there is a heated debate about the differences between the two. The best answer I found is the one in Francois Chollet’s excellent book “Deep Learning with Python.”

Imagine Data going into a black box, which uses Rules (classical statistical programming) and then predicts Answers:

One provides Statistics, the Data, and the Rules. Statistics will predict the Answers.

ML takes a different approach:

One provides ML, the Data, and the Answers. ML will return the Rules learned.

The last figure depicts only the training / learning phase of ML known as FIT – the model fits to the experiences learned – while learning the Rules.

Then one can use these machine learned Rules with new Data, never seen by the model before, to PREDICT Answers.

Fit / Predict are the basics of a ML model life cycle: the model learns (or train / fit) and then it predicts on new Data.

Why is ML Better than Traditional Statistics for Some Tasks?

There are numerous examples where there are no statistical models available: on-line multi-lingual translation, voice recognition, or identifying melanoma in a series of photos better than a group of dermatologists. All are ML-based models, with some theoretical foundations in Statistics.

ML has a higher capacity to represent complex, multi-dimensional problems. A model, be it statistical or ML, has inherent, limited, problem-representation capabilities. Think about predicting inpatient mortality based on only one parameter, such as age. Such a model will quickly achieve a certain performance ceiling it cannot possibly overpass, as it is limited in its capabilities to represent the true complexity involved in this type of prediction. The mortality prediction problem is much more complicated than considering only age.

On the other hand, a model that takes into consideration 10,000 parameters when predicting mortality (diagnosis at admission, procedures, lab, imaging, pathology results, medications, consultations, etc.) has a theoretically much higher capacity to better represent the problem complexity, the numerous interrelations that may exist within the data, non-linear, complex relation and such. ML deals with multivariate, multi-dimensional complex issues better than statistics.

ML model predictions are not bound by the human understanding of a problem or the human decision to use a specific model in a specific situation. One can test 20 ML models with thousands of dimensions each on the same problem and pick the top five to create an ensemble of models. Using this architecture allows several mediocre-performing models to achieve a genius level just by combining their individual, non-stellar predictions. While it will be difficult for a human to understand the reasoning of such an ensemble of models, it may still outperform and beat humans by a large margin. Statistics was never meant to deal with this kind of challenge.

Statistical models do not scale well to the billions of rows of data currently available and used for analysis.

Statistical models can’t work when there are no Rules. ML models can – it’s called unsupervised learning. For example, segment a patient population into five groups. Which groups, you may ask? What are their specifications (a.k.a. Rules)? ML magic: even as we don’t know the specs of these five groups, an algorithm can still segment the patient population and then tell us about these five groups’ specs.

Why the Recent Increased Interest in AI/ML?

The recent increased interest in AI/ML is attributed to several factors:

• Improved algorithms derived from the last decade progress in the math foundations of ML
• Better hardware, specifically designed for ML needs, based on the video gaming industry GPU (graphic processor unit)
• Huge quantity of data available as a playground for nascent data scientists
• Capability to transfer learning and reuse models trained by others for different purposes
• Most importantly,  having all the above as free, open source while being supported by a great users’ community

Articles Structure

I plan this structure for upcoming articles in this series:

• The task or problem to solve
• Model(s) usually employed for this type of problem
• How the model learns (fit) and predicts
• A baseline, sanity check metric against which model is trying to improve
• Model(s) performance on task
• Applications in medicine, existing and tentative speculations on how the model can be applied in medicine

In Upcoming Articles

• Supervised vs. unsupervised ML
• How to prep the data before feeding the model
• Anatomy of a ML algorithm
• How a machine actually learns
• Controlling the learning process
• Measuring a ML model performance
• Regression to arbitrary values with single and multiple variables (e.g. LOS, costs)
• Classification to binary classes (yes/no) and to multiple classes (discharged home, discharged to rehab, died in hospital, transferred to ICU, etc.
• Anomaly detection: multiple parameters, each one may be within normal range (temperature, saturation, heart rate, lactic acid, leucocytes, urinary output, etc.) , but taken together, a certain combination may be detected as abnormal – predict patients in risk of deterioration vs. those ready for discharge
• Recommender system: next clinical step (lab, imaging, med, procedure) to consider in order to reach the best outcome (LOS, mortality, costs, readmission rate)
• Computer vision: melanoma detection in photos, lung cancer / pneumonia detection in chest X-ray and CT scan images, and histopathology slides classification to diagnosis
• Time sequence classification and prediction – predicting mortality or LOS hourly, with a model that considers the order of the sequence of events, not just the events themselves

HIStalk Interviews Rizwan Koita, CEO, CitiusTech

Rizwan Koita is CEO of CitiusTech of Princeton, NJ.

Tell me about yourself and the company.

I’m the founder and chief executive officer of CitiusTech. We founded the company in 2005. This is my second company — I started a tech support company. Before that, I spent about five years with McKinsey & Company.

When you and I spoke last in 2015, CitiusTech was about 1,600 or 1,700 people strong. We are now at 3,200 people. It’s been a fairly strong growth year this past year and over the last few years. We do a whole bunch of stuff in healthcare technology for our customers across what we call the Clinical Value Chain.

What is driving the company’s strong growth?

From the revenue perspective, we are now part of the Healthcare Informatics Top 100. Our revenue was $127 million last year and are on track for close to $150 million this year. We also made a strategic investment in a company called FluidEdge Consulting, which is at about $25 to $30 million. We are hoping that, on a consolidated basis, we will end this year with revenue of about $175 million. As you can see, that’s a very significant jump from where we were last year.

The growth of the company is essentially coming in a couple of areas. We do a lot of work with payer organizations in the US market. We do a lot of work with provider organizations. Both of those markets have accepted CitiusTech solutions and our services very nicely. We also work with some of the medical software and technology companies and support their growth. That business is actually doing quite well. It’s a fairly homogeneous growth across our offering with providers and tech companies as well as with payer organizations. To a smaller extent, we work with pharma organizations as well.

There is a tremendous shift toward data management, a tremendous shift toward analytics, and now a significant shift toward data science and machine learning. We at CitiusTech have a significant amount of expertise in these areas. We’ve been able to do value-added work for our customers.

How will artificial intelligence and machine learning affect healthcare in the next five to 10 years?

I’m going to talk about history a little bit. Ten years back, the emphasis was on deploying what I would call foundational applications, such EMRs, health information exchanges, and connectivity software. A lot of big problems in data integration still remain and are getting solved. Steadily the focus of the industry has moved towards, what do we do with all the patient data, clinical data, financial data, and operational data that is getting generated? What’s the best way to manage that data? That could be on-premise, cloud, or a more traditional enterprise data warehouse versus big data solutions.

After the data management problem starts to get solved, the next logical question is, how do we start to use more analytics? Increasingly there is a lot of focus on what I would call the standard analytics, like regulatory reporting and and Level 1 analytics. But as the industry is maturing, we see a tremendous focus towards a slightly more advanced analytics. How do you take this massive amount of data that is now getting captured — EMR, lab, pharmacy, or claims — and put it together to be able to solve more complex problems? These are often not possible to solve using traditional analytics, But some large healthcare entities are using machine learning and AI tools to use that information to drive their problem solving.

If you look at the market, there are a lot of smaller proofs of concept and very interesting pilots going on. But the number of real-life deployed applications at scale is still small. You have lots of tools and utilities, but a small number are actually being used for inpatient care at scale. We are trying to help our customers solve that problem.

There is a dichotomy between what’s happening in pilots, research, or academic settings but little of it in production. In the next five to 10 years, we are going to see a tremendous number of successful models getting deployed in the real world for improving patient care, improving efficiency, and reducing cost, all of which are critical for healthcare.

Will use of AI and machine learning create a competitive advantage for health systems that deploy them more quickly or skillfully?

There will be a clear stratification of the types of organizations that can use machine learning and AI. At a simple level, if you take the provider market and hospital systems, a very large entity — Mayo Clinic, Cleveland Clinic, New York Presbyterian, Baylor Scott & White, and other large health systems — will be able to gather that information, and for research purposes or otherwise, build and create their own models.

The bulk of the healthcare ecosystem will largely be dependent on the vendor community to facilitate the use of such advanced tools. If I had to fast-forward five to 10 years, I would say that a lot of the deployment of these tools will be driven by the vendor community — EMR vendors, medical imaging vendors, lab services companies, or some of the other guys who have the financial, intellectual, and technical horsepower. They can aggregate large data sets, build models, and then test those models and get them through the FDA approval process and other barriers that are required before deploying these models in the real world. I see a greater likelihood of that happening. Some of the very large health systems also have a strong R&D inclination and have the ability to drive innovation, but that would be much harder for mid-tier and small hospital systems.

Thousands of models are being created today in healthcare using machine learning and AI. These models can be created in hospital research centers, academic institutions, or by five guys in a garage who have deep clinical insight. If you look at thousands of these models and then look on the production side, you find that the number of real-life applications in production is low.

The reason for that is that customers are getting bombarded by a lot of models — created internally or externally — but they don’t necessarily have the skills required for model validation. Imagine that I’m a large medical imaging company. Tons of folks are coming to me and saying they have great algorithms for medical imaging. I as a medical imaging company must have the horsepower to be able to put together a team that can independently take clinical data, run it through the models, validate the efficacy of the models, and fine-tune the models before I can validate whether the model is effective or not. Model validation is a huge pain area for the industry.

The second area is model operationalization. If you have a validated model, the task of integrating it with the clinical workflow is reasonably complex. Say, for example, that I have a model in medical imaging. Knowing that it’s a validated model, I still must be able to incorporate that model into the workflow of a radiologist. If it’s a colon cancer detection algorithm, then the characteristics of the colon cancer patient’s image needs to then fire up this AI or machine learning algorithm. The algorithm should be able to give back a response that is clearly visible to that radiologist or specialist who is looking at the colon cancer image. The radiologist should be able to either accept or reject the proposition or the findings of the machine, the AI algorithm. Once they accept it, that information should get fed back into the algorithm to incrementally optimize and enhance the algorithm. The result should be presented back as part of the report or to the patient or what have you.

It requires a certain degree of engineering effort to incorporate the model into the clinical workflow in addition to meeting the data science capability. To operationalize the model, you need a bundle of different skill sets — data sciences, product development, QA and validations, and perhaps FDA certification.

We find that technology companies and hospital systems that are trying to operationalize their data science models often don’t have that blend of capabilities that is required for them to truly operationalize the model. We end up with a scenario in which there are a lot of pilot models, the number of models that are validated are fewer, and the number of models that are operationalized is really, really small. Obviously these things will change in the next five years, so we’re at a very exciting juncture, but it will require a serious level of thought on the part of the stakeholders to be able to actually achieve the validation operationalization, which is one of CitiusTech’s core value-add to our customers.

Do you have any final thoughts?

Our company is on an interesting trajectory where are helping our customers drive innovation in healthcare. We are also seeing tremendous growth from a business perspective. I’m really excited about the kind of work that we are doing for the segments that I described. We are setting up a very strong advisory board that we will announce in the next two or three weeks. We’re doing other things to drive the growth of the company both organically and inorganically, actively engaging with other companies that may have complementary skills and solutions to ours. I’m really excited about the growth part of the company and looking forward to the next five years.

Morning Headlines 10/17/18

Influential Leapfrog Group Jumps In To Rate 5,600 Surgery Centers

Hospital grading organization Leapfrog Group will launch safety and quality surveys of the country’s 5,600 outpatient surgery centers after an investigation revealed poor oversight and substandard clinical practices.

M.I.T. Plans College for Artificial Intelligence, Backed by $1 Billion

MIT will spend $1 billion to create an artificial intelligence college spanning all five of its schools that will begin instruction in the fall of 2019.

This company, led by veteran athenahealth execs, just raised $300m

Medicare Advantage insurer Devoted Health raises $300 million in a Series B round, increasing its total to $362 million.

News 10/17/18

Top News

Radiation oncology and software vendor Varian Medical acquires Finland-based Noona Healthcare, whose software captures patient-reported outcomes and supports symptom management.

Reader Comments

From Managing Director, Otium cum Dignitate: “Re: HIMSS Form 990. Here’s the latest from Guidestar.” I should have been more specific in saying that I couldn’t find what I assume should be the latest HIMSS Form 990. I saw this one, which covers the year ending 6/30/16. HIMSS should have filed one last year and is due to file another one this year, but they haven’t responded to my request. More interesting is the title used by this semi-retired reader, who says he just likes the title “Managing Director” and the Latin from Cicero translates to “leisure with dignity,” which is about as cool a goal as someone could set for themselves (although the occasional episode of leisure with dishonor might keep it interesting).

From No Mas: “Re: Athenahealth’s partnership with U of Toledo. The new product for academic medical centers was supposed to be complete by now, three years after you interviewed CMIO Bryan Hinch, MD. Maybe you can reach out for an update.” I’ve emailed Bryan to see what happened since our interview about the co-development of an inpatient EHR as University of Toledo Medical Center tried desperately to unload its problematic and expiration-dated McKesson systems.

From Robert D. Lafsky, MD: “Re: this article. I think a big reason there’s so much lately about physician ‘burnout’ is that medical training teaches you to ask ‘why’ about everything. Even if it’s wrong, there has to be a theory. But when the EMR came along, it urged doctors to not ask so many questions, just do what it says. It’s remarkable that it took this long for a major medical journal to run a piece on the theoretical basis for computerized medical information.”  The NEJM article reviews the need for ontologies (controlled, descriptive terminology that describes the semantic relationships among concepts) to overcome the limitations of incomplete, incorrect, or unsourced EHR data since those systems were designed for billing, thus having no convenient way to store behavioral phenotypes, environmental exposure, genomic sequencing data, and information collected from mobile health sensors. It notes that use of ontologies on huge data sets can discover association and even causation to create new diagnostic and therapeutic insight. The authors also suggest that clinician data entry is not a good use of their time and advocates instead collecting device information and patient-entered information electronically and greater use of speech recognition.

HIStalk Announcements and Requests

Need consulting services? Fill out my minimally intrusive “RFI Blaster” online form (which I just rebuilt) with details about your needs and then choose one or all HIStalk consulting firm sponsors you’d like to hear from. It doesn’t get much easier.

I had another moment of music-driven cognitive dissonance in the senior citizen-filled grocery store the other day when in between sappy, buy-more-stuff music (Beach Boys, Pilot) was inserted “Break On Through (To the Other Side)” from the magnificent 1967 debut album of The Doors. I smugly felt rebellious as I noted no reaction from the older shoppers, but then I realized they were probably just suppressing the fist pumps since they were likely in their mid-20s peak rebellion years when the song charted 51 years ago. Mr. Mojo Risin’ himself would be 74 if he hadn’t broken on through to the other side at 27 in 1971. As I often say, nursing homes are now occupied by those who want to hear Pink Floyd rather than Lawrence Welk.

Webinars

October 30 (Tuesday) 2:00 ET. “How One Pediatric CIN Aligned Culture, Technology and the Community to Transform Care.” Presenters: Lisa Henderson, executive director, Dayton Children’s Health Partners; Shehzad Saeed, MD, associate chief medical officer, Dayton Children’s Health Partners; Mason Beard, solutions strategy leader, Philips PHM; Gabe Orthous, value-based care consultant, Himformatics. Sponsor: Philips PHM. Dayton Children’s Health Partners, a pediatric clinically integrated network, will describe how it aligned its internal culture, technology partners, and the community around its goal of streamlining care delivery and improving outcomes. Presenters will describe how it recruited network members, negotiated value-based contracts, and implemented a data-driven care management process.

Previous webinars are on our YouTube channel. Contact Lorre for information.

Acquisitions, Funding, Business, and Stock

Medicare Advantage insurer Devoted Health raises $300 million in a Series B round, increasing its total to $362 million. The founders are Todd Park (Athenahealth, Castlight Health, White House), his brother Ed Park (Athenahealth), and some VCs. Also on the team are former Athenahealth CTO Jeremy Delinsky and  former US Chief Data Scientist DJ Patil.

Sales

• Oregon will integrate its prescription drug monitoring program database with EHRs and pharmacy systems using Appriss Health’s PMP Gateway.
• Legacy Health (OR) goes live on Vynca for capturing, storing, and accessing advance care planning documents.

People

AAFP promotes Steven Waldren, MD, MS to VP/CMIO, where he will focus on the potential impact of AI and machine learning on family medicine and continue work on reducing EHR burden.

Announcements and Implementations

A KLAS report finds that two-thirds of health systems are just beginning to implement opioid stewardship programs, with the less-advanced ones considering best-of-breed technologies (such as drug dispensing systems that detect or prevent drug diversion) while more advanced health systems expect their EHR vendor to deliver tools to prevent and treat opioid misuse. Epic is the most-used of all technologies used in opioid stewardship programs, while Cerner is least-used.  Customers expect their EHR to integrate with prescription drug monitoring program databases, to offer opioid-specific clinical decision support and toolsets, and to include opioid stewardship capabilities in population health management.

This is smart approach: personal health record vendor HealthLynked publishes a plug-in that allows embedding its appointment-booking function in any of the 60 million websites that run WordPress. The screenshots suggest areas of needed improvement, however, since the dates run together and displaying appointment times down to the second seems silly.

A Reaction Data report says that only 15 percent of radiology departments still use dictation and transcription, with speech recognition dominating (although not growing) and 81 percent of respondents using Nuance and basically none of them thinking about switching to another vendor. Just over half of respondents say their speech recognition is integrated with PACS, but integration with RIS and EHR is much lower even though user satisfaction with the integration of all three is high.

Hospital grading organization Leapfrog Group will launch safety and quality surveys of the country’s 5,600 outpatient surgery centers, noting the need as evidenced by the Kaiser Health News/USA Today Network investigation that revealed poor oversight and substandard clinical practices. Let’s hope they call out the likely majority of those centers that refuse to participate (since until competitors start publicizing their good results, there’s no incentive). The organization issues grades for 2,000 US hospitals, just over one-third of the total.

A hospital in eastern China goes live with facial recognition check-in on a system developed by Alibaba’s healthcare group. Anyone with health insurance and a mobile payment account can register without their ID cards or phones once they have linked their accounts to the Alipay mobile payment app. The system’s 3-D cameras link to Alipay’s biometrics and the Ministry of Public Security’s photo database, which is also used by police to identify the faces of fugitives in large crowds. 

A Philips study finds that the US healthcare system captures a lot of data compared to other countries, but suffers from lack of a universal health record and low consumer satisfaction and trust.

Government and Politics

Telemedicine vendor HealthRight and its CEO Scott Roix plead guilty to healthcare fraud and fraudulent marketing of dietary supplements, skin creams, and testosterone that its doctors prescribed without realizing how massively the company was marking up the prices. A total of four men and seven compounding pharmacies were named in charges of running a billion-dollar telemedicine fraud scheme.

Other

Another healthcare information challenge – a person’s genetic test results could change from “normal” to “abnormal” or vice versa based on new research findings, but nobody has thought about the challenges in contacting those patients or their doctors to let them know or to have them retested. A recent study found that of 1.45 million patients tested from 2006 to 2016, reclassification of mutations would have changed the reports of 60,000 of them.

UMass Memorial Health Care lays off 17 IT employees two weeks after going live with its $700 million Epic implementation. 

MIT will spend $1 billion to create an artificial intelligence college that will begin instruction in the fall of 2019. MIT says the intentionally used term “college” reinforces that the new organization will work across all five of its existing schools (architecture, engineering, humanities, management, and science) rather than being a school itself. It adds that the college will emphasize ethical guidelines of how AI can be used for human good.

Amazon posts job listings for data scientists with health benefits experience to work with partners – “including the new healthcare venture” – to create healthcare and population health management solutions. Most interesting is the responsibility to “leverage big data to explore and introduce areas of healthcare analytics and technologies” and preferred experience that includes working with claims, EHR, and patient-reported data. I have a strong feeling that if Amazon ever meets high expectations for healthcare disruption that this Atul Gawande-led group won’t be its weapon of choice – while the company will learn a lot about how healthcare works, the goal is to reduce its own costs, with no guarantee that those efforts will extend outside its four walls. The company’s real disruption opportunity likely lies elsewhere and that are more easily penetrated, such as in supply chain management.

A jarringly moving obituary written by the parents of a 30-year-old mother who died of a drug overdose last week provides a sad reminder of the toll of drug addiction on families. Some excerpts (but you should read the whole thing):

It is impossible to capture a person in an obituary, and especially someone whose adult life was largely defined by drug addiction. To some, Maddie was just a junkie — when they saw her addiction, they stopped seeing her. And what a loss for them … During the past two years especially, her disease brought her to places of incredible darkness, and this darkness compounded on itself, as each unspeakable thing that happened to her and each horrible thing she did in the name of her disease exponentially increased her pain and shame. For 12 days this summer, she was home, and for most of that time she was sober. For those 12 wonderful days, full of swimming and Disney movies and family dinners, we believed as we always did that she would overcome her disease and make the life for herself we knew she deserved. We believed this until the moment she took her last breath. But her addiction stalked her and stole her once again. Though we would have paid any ransom to have her back, any price in the world, this disease would not let her go until she was gone.

If you are reading this with judgment, educate yourself about this disease, because that is what it is. It is not a choice or a weakness. And chances are very good that someone you know is struggling with it, and that person needs and deserves your empathy and support. If you work in one of the many institutions through which addicts often pass — rehabs, hospitals, jails, courts — and treat them with the compassion and respect they deserve, thank you. If instead you see a junkie or thief or liar in front of you rather than a human being in need of help, consider a new profession.

Bizarre: Sacramento police can’t figure out what charges to file against two high school students who handed out cookies at school that contained a secret ingredient – the cremation ashes of one of their grandparents.

Weird News Andy call’s “Rocky’s Revenge” as a New York State hunter dies of a brain disorder after eating the brain of a squirrel he shot. WNA says the incidence of the variant of Creutzfeldt-Jakob disease is high around Rochester, NY, which is a long way from Frostbite Falls, MN.

Sponsor Updates

• AdvancedMD will exhibit at the American Medical Billing Association National Conference October 18-19 in Las Vegas.
• CompuGroup Medical will exhibit at the Arizona MGMA Annual Conference October 17-19 in Chandler.
• Collective Medical partners with the Kentucky Hospital Association.
• Imprivata’s Mobile Device Access completes validation for use with select Zebra devices.
• CoverMyMeds will exhibit at the CBI Real-Time Benefit Check and ePrior Authorization Summit October 17-18 in San Francisco.
• CTG will exhibit at the 2018 Northwest Arkansas Technology Summit October 22-23 in Rogers.
• Cumberland Consulting Group will exhibit at the CBI Value-Based Oncology Management Forum October 23-24 in Scottsdale, AZ.
• Direct Consulting Associates will exhibit at the Western PA Healthcare Summit October 19 in Cranberry Township.
• Dimensional Insight will exhibit at the Value-Based Care Summit October 17 in Boston.
• DocuTap is accepting nominations for its student scholarship program.
• Redox will host its Healthcare Interoperability Summit November 13-14 in Denver.

Blog Posts

• Onboarding Remote Employees with Speed and Ease (Access)
• 6 ways providers are revolutionizing mental health care through new technology (Advisory Board)
• Safety matters: Keeping patient safety in mind (Agfa Healthcare)
• Points to Consider for EHR Optimization (Optimum Healthcare IT)
• Help Me Alexa, I’m in Pain (Spok)
• Patients want doctors to talk to them about more than just physical symptoms, medications (AssessURHealth)
• HIPAA Compliant Server for a Client Portal Solution (Atlantic.net)
• Bluetree’s take on the new Epic release cycles (Bluetree)
• AWS re:Invent Healthcare Developer’s Conference Guide (Datica)
• Fall Events Recap: Reporting back from IM Symposium, NAACOS, and AHCA (CarePort Health)
• How Payers and HIT Analytics Can Help Primary Care Physicians Improve Care Quality (Change Healthcare)
• 7 Recruiting Trends That Will Continue into 2019 (Direct Consulting Associates)
• Navigating the Path to Value-Based Care (Dimensional Insight)

Contacts

Mr. H, Lorre, Jenn, Dr. Jayne.
Get HIStalk updates. Send news or rumors.
Contact us.

Morning Headlines 10/16/18

Anthem Pays OCR $16 Million in Record HIPAA Settlement Following Largest U.S. Health Data Breach in History

Anthem will pay the HHS Office of Civil Rights $16 million to settle HIPAA violations from a 2015 data breach that impacted 79 million people.

Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

HealthRight President Scott Roix pleads guilty to felony conspiracy charges related to a telemedicine scheme that bilked payers out of nearly $1 billion.

Varian Expands Cancer Care Portfolio with Noona Healthcare Acquisition

Cancer care technology company Varian Medical Systems acquires Noona Healthcare, a developer of oncology patient-reported outcomes software.

Dell Medical School Professor Joins Prestigious National Academy of Medicine

Dell Medical School Professor and former ONC head Karen DeSalvo, MD becomes a member of the National Academy of Medicine.

UMass Memorial Health Care lays off 17 workers

Faced with a $22 million operations shortfall, UMass Memorial Health Care lays off 17 IT staff as part of system-wide downsizing efforts that have included the closure of several facilities.

Curbside Consult with Dr. Jayne 10/15/18

As an urgent care physician, I enjoy the satisfaction of being able to make a bad day better for many of my patients. Although I live in a major metropolitan area, there is a relative shortage of primary care physicians (at least ones taking new patients). For those patients who have primary physicians, there’s a shortage of same-day and after-hours appointments that mesh with patients’ busy schedules and their desire for convenience.

I’m happy we can meet our patients’ needs, but I’m often conflicted about the fact that delivering what is essentially primary care in an urgent care setting often contributes to the fragmentation of care. That’s in addition to the cost contribution, because a visit with us typically costs more than a visit to a primary care physician due to negotiated contract rates with payers and higher co-pays for patients.

The fragmentation could potentially be reduced through better technology, particularly better interoperability. Our EHR allegedly has all the interoperability bells and whistles, but local hospitals and their owned physician groups aren’t too keen on sharing data with competitors despite our desire to deliver better patient care. Our state HIE’s provider-centric pricing model makes it cost prohibitive for us to connect, given that the majority of our providers are part time. Even if it were more economical, our HIE is largely read-only, which doesn’t do a lot for the efficiency or accuracy of being able to bring patient data to life in the chart.

A good chunk of our patient volume happens before 9 a.m. and after 5 p.m., which is a testament to the fact that patients want to receive care at a time that is convenient for them, even if it might be more expensive. They also like being able to get care same day and not have to wait for 3-5 days for an appointment for straightforward medical problems. Many of our patients are hourly workers who don’t have paid sick time, and even those who have sick days may be challenged to find two or three hours to visit their primary physician during the work day.

I often think of the reasons behind why people choose to get their care when and where they do, so this Kaiser Health News article caught my attention.

The article covers the idea that millennials are at the forefront of wanting convenience when selecting their care and tend to choose urgent care, telemedicine, and retail clinic options. A poll of 1,200 adults found that younger patients were less likely to have a primary physician, ranging from 45 percent of patients ages 18 to 29 and declining to 12 percent for those age 65 and older. We see that play out in practice, whether it’s strictly due to the convenience angle or whether it’s due to a lack of available primary care capacity.

However, I’m seeing more patients in the Baby Boomer demographic who may have a primary physician, but choose to come to urgent care because they’re busy in their retirement and don’t want their schedules upset by needing to seek medical care.

I have several friends who are dabbling in telemedicine as an adjunct to their regular primary care practices. They report that patients have discussed their desire to handle medical issues at the time and place of their choosing, whether they actually get to interact with the physician face to face or not. Patients are used to transacting the business of their lives online, whether it’s banking or retail, and since healthcare has become a commodity, it’s no different.

One colleague notes that while the patients are glad she’s offering the service, many of them would be just as happy seeing any other physician and not specifically her. We’ve moved into a generation where patients no longer have a primary care physician for life. They may have one for three or four years and then have to change because their employer selected a different network, or they may change due to relocation and the more fluid lives that people tend to live now.

There are concerns that moving away from that continuity where physicians know their patients not only drives up costs, but also leads to inappropriate antibiotic use or misdiagnosis. We see patients who come in specifically because “my primary wouldn’t call me out a Z-pack” and spend a lot of time educating them about viral illnesses. At least we can send them home with medications to help with their symptoms, which makes them feel like they’ve done something to get better even if it’s not an antibiotic. There’s a powerful psychology in that.

We also see patients who have been to their primary care physician and also a subspecialist, but feel like their problem isn’t being addressed so they come to us “for another opinion.” It’s difficult to explain that we’re not experts and if they’ve been to a subspecialist at one of the local academic medical centers and there’s not an answer, that we’re unlikely to find one at the urgent care with our limited testing and radiology capabilities.

I’m particularly interested in the concept of delivering regular primary care via telemedicine, rather than just care for urgent and acute issues. Virtual visits have the power to revolutionize what we do, adding convenience for both patients and providers. In order to be successful, though, we have to get payers and policies aligned to pay for them so that physicians will be more likely to offer them. We also have to get technology aligned, including robust patient portals, the ability for patients to upload their own health data and documents, and better understanding from mid-career physicians that telemedicine isn’t going to suck away their evening and weekend hours.

I think about all the hours that my practice spent trying to track down patients and get them to come in for appointments back when I was in the primary care trenches. I would bet that at least half just disliked the process of going to the doctor and would have been game to do a virtual visit.

I’m excited about projects that pair community health workers with physicians to deliver a combination of in-home contacts with virtual physician visits, particularly in rural areas. A friend of mine recently received a grant in that regard, and I can’t wait to hear how it plays out in real life. I know she is having some challenges figuring out how to actually deliver the services, whether to try to integrate something with her EHR or to use a third-party telemedicine solution. It sounds like the options among vendors vary dramatically, so she is going to keep me posted on her progress.

Are you a physician who regularly incorporates virtual visits into care, or a healthcare IT person who supports one? I’d love to hear from you. Leave a comment or email me.

Email Dr. Jayne.

Readers Write: Hurricanes Michael and Florence Remind Us Why We Need a Data Backup Plan

Hurricanes Michael and Florence Remind Us Why We Need a Data Backup Plan
By Marty Puranik

Marty Puranik is president and CEO of Atlantic.Net of Orlando, FL.

The immense flooding of Hurricanes Michael and Florence across the Florida Panhandle and southeastern areas of the Carolinas, respectively, is yet another business reminder of the omnipotent power of natural disasters. The devastating chaos and aftermath of the massive storms bring into sharper focus a humbling affirmation of the critical need to safeguard health data.

The data backup plan is a mandatory stage of HIPAA compliance requiring healthcare organizations to create, implement, and maintain a set of rules and procedures to follow when managing the backup and restore requirements of electronic protected health information (ePHI).

The data backup plan encompasses wider contingency planning processes that include your chosen business associate (BA) or managed service provider (MSP). The company engaged to remotely or on-site manage your plan must demonstrate a compliant backup service capable of backing up and restoring exact copies of ePHI. 

In choosing a backup service for business continuity and HIPAA compliance, it is critically important to understand the HIPAA Security Rule requirements. This rule demands a backup solution that adheres to the following criteria:

• Use of data encryption. Backup data is expected to be encrypted at rest and in transmission. This encryption is achievable by using a storage hardware or operating system-level encryption techniques.
• User authentication safeguards. Applying unique multi-factor password protection is accomplished using Active Directory and a token-based security key such as PKI.
• Role-based access rules. Users are restricted access on a need-to-know basis following a least-privileged design. These measures help prevent access to backup data by unauthorized personnel.
• Offsite storage capabilities. Backups must be stored in a separate location to production services.
• Secure data center facilities. This measure applies to the facility security processes such as SSAE 16 SOC1 and SOC2 standards.
• Detailed monitoring and reporting functions. Backups must be reported upon and alerts generated in the event of failure.

Moreover, leaving any best-laid plan involving patient data to chance opens to the door to security risks. Proactively test your data backup plan to ensure the MSP’s systems work harmoniously in any unexpected situation. Testing procedures can include:

• File-level restore. A file-level restore involves one or several files restored to the file system. This can be set up on the original server or to a different location.
• VM-level restore. If the MSP deploys virtualization technology, a full virtual machine restore can be performed. The server then can be tested for functionality.
• Application-level restore. A common application restore is a database from inside a Microsoft SQL server instance or a mailbox from Microsoft Exchange. This test guarantees data integrity and verifies that correct permissions and security configuration are recovered.

I often recommend to providers to delegate the backup and restore responsibilities to a compliant cloud or backup-as-a-service (BaaS) offering. The MSP determines the type of backup media to use, which is usually disk-based storage. Once successful backups are achieved, the next step is the restore process for testing to validate the data’s integrity. The testing also assures the backup engineer’s ability to restore data in tandem with the precise speed of timing to complete the process.

Integration within a wider contingency plan is also essential as a failsafe for the data protection. Most MSPs offer disaster recovery technology capable of failing over data and services to a secondary location almost instantaneously. However, be aware that backups are often considered the last line of defense in the event of a catastrophic system failure. The contingency plan authorizes instant data restoration capability in the worst possible case scenarios.

To meet HIPAA security rule requirements, the BaaS platform incorporates offsite backup technology that will offload entirely the ePHI healthcare infrastructure to an external location. The offloading is most frequently performed through site-to-site replication technology or even by shipping backup tape media to a compliant external location. Since backup data is transferred externally over a network, determining the network security being provided by the MSP is imperative to prevent breaches.

Hurricanes Michael and Florence clearly bring into focus the need for emergency preparedness to protect the security of patient data. Indisputably, losing data has huge consequences for healthcare providers who routinely handle sensitive and private ePHI. For example, if access to a critical pharmacy, lab or EHR system is severed, a medical practice struggles to recover and continue its business operations. Reputations are damaged. More importantly, patient lives are put at risk.

Like insurance plans, a data backup plan is there when you most need it as an integral part of your overall business strategy. Before the next natural disaster strikes, what is your backup plan?

Readers Write: The Compliance Difficulties of Medical Device Connectivity

The Compliance Difficulties of Medical Device Connectivity
By Abbas Dhilawala

Abbas Dhilawala, MS is CTO of Galen Data of Houston, TX.

There are numerous challenges facing the global healthcare ecosystem today, including aging populations that require more healthcare products and services; rising costs across the industry (shared among consumers, insurance carriers, healthcare providers, and taxpayers); growing wait times for medical services; and a growing demand for convenient and personalized care.

To address these challenges, medical device companies are beginning to produce medical devices with cloud connective capabilities that promote the digitization of healthcare and promote better physician-patient engagement while driving down costs. The global market for connected medical devices is expected to increase from $21 billion in 2018 to $63 billion by 2023, an annual growth rate in excess of 25 percent, according to one report.

Still, the path forward for medical device companies that want to design the connected medical devices of the future and get them to market isn’t always clear and direct. Medical device manufacturers are subject to extensive regulations and compliance requirements for the medical devices that they produce. A recent survey of 237 medical technology employees by Deloitte found something important: 67 percent believe that the current regulatory framework will not catch up with what we can do with medical device technology today for another five years.

Medical device companies today face a fractured compliance landscape that can stifle innovation and lead to heavy expenditures in compliance activities at the expense of research and development. Medical device companies that wish to sell their devices in the United States must comply with the quality regulations set forth by the United States Food and Drug Administration (FDA) in Chapter 21 of the Federal Code of Regulations, Part 820. The regulations include guidelines for ensuring the safety and effectiveness of medical devices, including the establishment of detailed design control documentation, the creation and maintenance of processes for corrective and preventive actions when non-conforming products are discovered, and requirements for document control and approval.

Quality system regulations exist around the world in different forms. Canada uses the Canadian Medical Devices Regulations (CMDR), while medical devices sold in Europe must obtain a CE Marking through compliance with ISO 13485, the international standard for medical device quality. Each time a medical device company enters a new market, it must demonstrate compliance with the corresponding local quality system regulations. Sometimes this means conducting a gap analysis and addressing compliance issues internally, but it could also mean hiring a Notified Body to conduct an expensive and time-consuming third-party compliance audit.

To help ease the path to compliance for medical device companies and reduce the cost burden of compliance activities, regulators worldwide are working towards a Medical Device Single Audit Program (MDSAP) that can establish medical device compliance for global markets based on a single audit. While this measure should reduce compliance costs for medical device companies, it remains to be seen how connected medical devices will be regulated under a new system.

As healthcare innovators continue to develop connected medical devices, privacy is a growing concern for regulators and industry professionals. Imagine a future where in-home care is increasingly common and where patients use wearable and implantable medical devices that deliver patient data electronically in real time to a central repository of electronic medical records.

Such a future might not be far off. The EHR mandate already requires hospitals and medical clinics across the United States to use electronic medical records to track patient data, and connected devices with data transmission capabilities already exist. What doesn’t exist yet is a common framework that promotes interoperability between connected devices and patient databases or any kind of privacy and security regulations that would safeguard such a system against malicious attacks that could compromise patient data.

The final compliance issue faced by manufacturers of connected medical devices has to do with changing payment models throughout the healthcare industry. As the industry shifts towards a model that compensates healthcare providers based on the effectiveness of treatments and patient care outcomes, government regulators and payers are increasingly asking for objective evidence that medical devices are positively impacting patient outcomes. Manufacturers of connected medical devices may face additional compliance obstacles when required to demonstrate that their devices actually improve patient engagement, satisfaction, and outcomes.

Despite the compliance difficulties faced by the industry, medical device manufacturers are meeting the challenge head on by innovating new ways of doing business, including funding models that offer data as a service, the adoption of value-based pricing, and the use of real-world patient data to drive business decisions. The medical device companies of today are ready to advance healthcare into the future. Now it’s up to healthcare providers and regulators to keep up.

Morning Headlines 10/15/18

Cloud-Based Digital Pathology Startup Deep Lens Exits Stealth Mode With $3.2 Million Seed Financing

Pathology image detection support system vendor Deep Lens announces $3.2 million in seed funding and availability of its free VIPER service for pathologists.

Athenahealth has multiple bidders for sale of the company

Sources suggest that four private equity firms and activist investor Elliott Management are considering placing a bid to acquire Athenahealth.

Sloan Kettering Researchers Correct the Record by Revealing Company Ties

Several prominent Memorial Sloan Kettering Cancer Center researchers update their conflict-of-interest disclosures in previously published journal articles, adding previously undisclosed financial ties to drug companies.

Theranos Criminal Case Is Broader Than Publicly Disclosed, Prosecutors Say

A judge rejects a bid by former Theranos executives Elizabeth Holmes and Ramesh Balwani to block prosecutors from accessing over 200,000 company documents, alluding to a broader investigation that may extend beyond the two defendants.

Monday Morning Update 10/15/18

Top News

Pathology image detection support system vendor Deep Lens announces $3.2 million in seed funding and availability of its free VIPER service for pathologists.

Co-founders of the Columbus, OH-based company are CEO Dave Billiter, MBA (Cardinal Health) and President Simon Arkell, MBA (Predixion Systems).

The company is based on work first performed at Nationwide Children’s Hospital in Columbus.

I like an uncredited quote in a company blog post that says you can’t rely too much on company experts whose user experience still makes them “FORMER experts in the field.” It also notes that product feedback from anyone other than a customer should be politely answered with, “Your opinion, although interesting, is irrelevant.”

Reader Comments

From Biometric Believer: “Re: biometric ID. Would you mind asking your readers why, with advances in technology and increased fraud, hospitals aren’t deploying more iris scanning to patient care locations?” Good question, although I would expand your question to include palm vein scanning, facial recognition, voice recognition, and other less-used forms of biometric ID that hold equally promising potential without the need to approach someone’s eyeball with a scanner. There’s no question that all of these technologies work, only that consumer perception isn’t always great and healthcare and other industries (even banking) have resisted accordingly despite its obvious utility in fraud prevention. Some problems I see:

• Cost. Although technology costs are going down, deploying biometric readers broadly is a big expense and requires a coordination effort that you don’t want repeat often as those technologies change.
• Workflow integration, which has been mostly solved, I expect.
• The creep factor. Years ago I got the job of convincing nurses that our newly implemented fingerprint scanning for drug dispensing machines did not mean we were storing their fingerprints or checking them for criminal history.
• If hackers breach your system or someone grabs a patient’s fingerprints or takes a picture of their face, your patient is screwed because unlike passwords, they can’t change their biometrics.

My conclusion is that perhaps all of these problems could be solved by using the patient’s own phone as the biometric reader. People are happily using fingerprint recognition, voice recognition, and in some cases with higher-end phones, facial recognition to identify themselves for their own security. You would think that the hospital’s reader could connect via Bluetooth, although that’s a minor patient setup issue as well. Or, to address that issue as well as the fact that not everyone has a cell phone, maybe the hospital could use its own cell phones, handing one over temporarily to the patient to provide a less-threatening biometric ID process using a familiar consumer device.

For Biometric Believer, I created a poll for providers to say if they’re using biometric patient ID or why they don’t. Vote and then add a comment to elaborate.

From Arthur Allen: “Re: HIStalk. I spotted a rare error in Friday’s update. The VA’s assignment of Paul Tibbits to executive director for the Office of Electronic Health Record Modernization is not a direct replacement of Genevieve Morris. Title-wise at least, Tibbits and Morris differ. She was CHIO, but was also ostensibly in charge of OEHRM. Tibbits is the exec director and they described his job a little differently as well,  more of a liaison with OIT, leaving Captain Windom in charge of OEHRM.” Good point, thanks. John Windom, III led the Cerner selection and rollout by the DoD. Arthur is Politico’s e-health editor who made me beam with his “rare” adjective.

From Kermit: “Re: pre-existing conditions. NPR has a good analysis of the nuances.” The article notes that Republican leaders recognize that it’s politically unwise to take a stand against pre-existing conditions since at least 25 percent of us have them, yet their continued efforts to dismantle the Affordable Care Act and to encourage junk insurance plans as an alternative are making them legal once again after several years. Medicare and Medicaid don’t have pre-existing condition limitations, so claims by Democrats that everyone would be impacted by ACA changes isn’t accurate. HIPAA is a factor since most Americans get health insurance through their employer and HIPAA doesn’t allow those insurers to deny coverage or price premiums based on medical history, but even that’s complicated since some HIPAA protections were moved into the ACA and might die along with it if ACA doesn’t survive legal challenges given the White House’s strategy of not defending it vigorously. TL; DR: everybody hates pre-existing conditions except politicians, who will throw those who have them under the bus if it helps their party.

HIStalk Announcements and Requests

I ran this poll to encourage folks who are struggling with an involuntary career change. Respondents who were fired, laid off, or relocated a few years back overwhelmingly say it turned out to be a positive development.

Marketing Guy was let go the same week he and his newly pregnant wife bought a new house, but he eventually got two job offers, took one that allowed him to move his family to Europe, and rose within that company’s ranks over 10 years. His advice is to keep working hard (even if that work involves job-hunting), keep learning, and stay positive. Hermanator was fired due to office politics from a company he had helped start, but he says it was the best thing that could have happened because he then started an even better company. He advises that folks take a break, reflect, learn from any mistakes they made, focus on their strengths, and find a new opportunity they can get passionate about.

New poll to your right or here: which would you value most highly in your personal doctor? You don’t get an “other” or intellectually lazy “all of the above” option because it’s my poll and I know what I’m trying to assess, but those who feel deprived that they weren’t given an essay question can click the “Comments” link after voting and opine away.

Old friend of HIStalk Alex Scarlat, MD (we first corresponded sometime before 2011, I found by searching my old emails) is doing fun work on his own with machine learning. Check out his DogBreed.io, which can identify a dog breed from a photo with 97 percent accuracy (giving you some idea of the excitement behind using ML for diagnostic imaging analysis). He says he wrote it in under 50 lines of Python code. Alex has also done some work with weather prediction that is showing high accuracy. I have suggested that he consider writing a primer series on machine learning for clinicians for HIStalk, a non-technical review of what’s inside the black box and where it might be good (or not so good) for healthcare applications.

I realized that my ancient Yahoo Mail account is a treasure trove of 80,000 emails going back to August 2004, 14 months after I started HIStalk (I don’t recall which email provider I used before then). Reading the names of defunct companies, seeing email from now-retired or deceased industry people, and marveling at my energy and exuberance in my emails way back then made me nostalgic. Yahoo Mail is still the best service I’ve used and its search is excellent, so let me know if there’s something fun I should search for (people, companies, unflattering terms, etc.) I found my first-ever interview from late 2004 that I thought was lost forever (with Meditech’s Howard Messing); planning emails from the first HIStalkapalooza in 2008; and threats from an industry magazine’s publisher who was unhappy that I ridiculed a newly assigned health IT reporter who was hired from a pastry magazine.

Webinars

October 30 (Tuesday) 2:00 ET. “How One Pediatric CIN Aligned Culture, Technology and the Community to Transform Care.” Presenters: Lisa Henderson, executive director, Dayton Children’s Health Partners; Shehzad Saeed, MD, associate chief medical officer, Dayton Children’s Health Partners; Mason Beard, solutions strategy leader, Philips PHM; Gabe Orthous, value-based care consultant, Himformatics. Sponsor: Philips PHM. Dayton Children’s Health Partners, a pediatric clinically integrated network, will describe how it aligned its internal culture, technology partners, and the community around its goal of streamlining care delivery and improving outcomes. Presenters will describe how it recruited network members, negotiated value-based contracts, and implemented a data-driven care management process.

Previous webinars are on our YouTube channel. Contact Lorre for information.

Acquisitions, Funding, Business, and Stock

Four private equity firms and activist investor Elliott Management are considering placing a bid to acquire Athenahealth, sources suggest. Pamplona Capital, which was previously rumored to be interested in acquiring the company and merging it with its NThrive holding, is not listed in the latest round of rumored potential acquirers but is presumably still in the hunt. ATHN will announce earnings on Thursday. Somehow you get the feeling that Elliott’s malicious manipulation isn’t going to be good for Athenahealth, its customers, or the health IT industry, but I’m sure some money guys will figure out how to enrich themselves while creating nothing more than mayhem.

Valley Presbyterian Hospital (CA) tries to ride the coattails of the new Neil Armstrong movie “First Man” by reminding everyone that it was the first hospital to use telemetry-based patient monitoring back in 1966, when Spacelabs took NASA’s astronaut monitoring product into healthcare.

Sales

• Drug maker Allergan joins TriNetX’s global health research network to analyze patient cohorts, choose study sites, and determine drug study protocol feasibility.
• The Kentucky Hospital Association joins Collective Medical’s care collaboration network to allow state hospitals to identify patients with a history of substance abuse or treats to ED staff safety as well as to identify and support complex patients.

Decisions

• Select Specialty Hospital-Johnstown (PA) will replace Medhost with Epic in 2019.
• Maury Regional Health System (TN) will implement Cerner in November 2018, replacing Meditech.
• Mercy Medical Center (MA) went live with Epic in September 2018.
• Washington County Regional Medical Center (GA) will go live with Evident financial management on November 1, 2018.

These provider-reported updates are supplied by Definitive Healthcare, which offers a free trial of its powerful intelligence on hospitals, physicians, and healthcare providers.

People

Wayne, PA-based behavioral health solution vendor Tridiuum hireshttps://tridiuum.com/tridiuum-expands-executive-team-with-cro/ Chris Salvatore, MBA (Halo Communications) as chief revenue officer.

Intelligent Medical Objects promotes Eric Rose, MD to VP of clinical informatics.

Announcements and Implementations

Mayo Clinic has been going live with the Visage 7 Enterprise Imaging Platform along with its Epic go-lives, finishing up last week at its Jacksonville and Scottsdale campuses. Mayo now has a single enterprise imaging platform and diagnostic viewer along with Epic-driven interpretation workflow across its national network.

Maitland, FL-based Therigy, which sells specialty pharmacy software for therapy support and patient assessment, says it has reached 100 million patient engagement activity and assessment responses. The company offers care plans and assessments for 20 conditions, with 900 assessments covering 400 medications.

Government and Politics

A tweet by CMS Administrator Seema Verma implies that EHR vendors are responsible for the lack of interoperability adoption (which I’m wording intentionally as a combined technical and business problem as opposed to “lack of interoperability capability” as a purely technical issue). She says “doctors should be able to seamlessly exchange data between EHRs,” failing to note that many of them who are properly motivated already do in proving the product’s capability, while those using the very same EHR often remain as information silos.

The government of China expands its e-healthcare regulations:

• Commercial companies can collaborate with providers to offer electronic diagnosis, telemedicine, or e-hospitals, but they can’t provide those services on their own.
• Only licensed professionals with at least three years of clinical practice experience can offer online diagnostic services.
• Patients can use online clinical services only for follow-up visits. Physicians must refer patients to traditional channels otherwise.
• Remote consultation and prescribing is allowed as an adjunct to a hospital visit.
• Controlled substances may not be prescribed as part of a telemedicine visit.

Other

You won’t like this if you think HIMSS already has too much influence by running its own conference, media, and advertising empire and absorbing competitors by acquisition. HIMSS will help health services research organization AcademyHealth run Health Datapalooza 2019, which used to be a rather quiet conference targeting mostly federal government leaders and data wonks. You may take it to the bank (and HIMSS will) that the exhibit hall is going to get a lot bigger.

HIMSS haters might not like this, either. HHS will work with Healthbox (acquired by HIMSS a few months ago) to convene quarterly Deputy Secretary’s Innovation and Investment Summit meetings to ask investors which policies are standing in the way of innovation. Healthbox is a business accelerator that HIMSS acquired to expand its consulting, investment fund management, and startup assistance programs in uncovering yet another way to compete with its paying members.

Speaking of HIMSS, they’ve yet to respond to my October 2 request for their non-profit Form 990 federal filing, which they are required by law to provide (but maybe not promptly), even though I notice that I fawningly and mistakenly said “please” twice in the same sentence. I’m always interested in its salaries, revenue by segment, and the occasional buried information about its acquisitions.

The American Nurses Association’s journal celebrates National Health Information Technology Week with observations about EHR nurse documentation:

• Data models do not accurately capture nurse assessment and interventions, focusing instead on patient demographics, diagnoses, and procedures instead of the actions that nurses take.
• All care team members should be able to add to the electronic care plan documentation, including non-clinical information such as social determinants of health, and that documentation should be supported by health IT standards.
• A study has found that the EHR requires 593 clicks for a nurse to complete the nursing admission assessment and that 31 percent of the required items were already documented elsewhere, motivating Vanderbilt University Medical Center to create a “click gatekeeper” team that must approve requests to add items to the nurse documentation record.

Several prominent Memorial Sloan Kettering Cancer Center researchers update their conflict-of-interest disclosures in previously published journal articles, adding previously undisclosed financial ties to drug companies. One doctor added 31 company affiliations, while another’s updated long list of company ties includes being paid consulting fees, owning stock options, and co-founding a company. MSKCC says each journal has its own disclosure requirements and some require authors to disclose relationships unrelated to the study being published, complicating the issue.

Weird News Andy titles this story as “CO and Old Lace.” In China, an anesthesiologist who was having an affair with the tutor of his children is sentenced to life in prison for killing his wife who refused to divorce him (his 16-year-old daughter also died as unintended collateral damage) by filling a yoga ball with carbon monoxide, removing the stopper, and placing it the trunk of his wife’s car. The deflated ball raised the suspicions of police, who then found that the doctor had ordered the carbon monoxide from his university employer claiming he needed it to perform animal tests.

Sponsor Updates

• Intelligent Medical Objects chairman, chief innovator, and co-founder Frank Naeymi-Rad, PhD, MS, MBA will be inducted into the American College of Medical Informatics at AMIA’s annual symposium in San Francisco November 3-7.
• InterSystems makes its IRIS Data Platform available in the Microsoft Azure Marketplace.
• Waystar will exhibit at HFMA Region 2 Conference October 17-19 in Verona, NY.
• Nordic will exhibit at the Georgia HIMSS Annual Conference October 16 in Atlanta.
• Clinical Computer Systems, developer of the Obix Perinatal Data System, will exhibit at the AWHONN Iowa Section Conference October 16 in Des Moines.
• Recondo Technology will present at the Health Management Academy’s CFO Forum 2018 Meeting October 17-21 in Deer Valley, UT.
• Experian Health will host its 2018 Financial Performance Summit October 22-24 in Dallas.
• Redox partners with Smart Health Innovation Lab to help innovative healthcare startups accelerate time to integration.
• Sunquest will exhibit at ASHG 2018 October 16-20 in San Diego.
• Surescripts CEO Tom Skelton will keynote the Value-Based Care Summit October 17-19 in Boston.
• T-System offers disaster relief sheets free of charge to hospitals in the path of Hurricane Michael.
• Voalte will exhibit at the 2018 Michigan Nursing Summit October 18-19 in Lansing.
• FormFast joins the Zen Healthcare IT Interoperability Community.
• ZeOmega will exhibit at the 2018 CAHP Annual Conference October 22-24 in San Diego.

Blog Posts

• Getting Unstuck from Your Legacy Integration Technology (Liaison Technologies)
• Communication Plan, Collaboration & Continuity: CMS Emergency Preparedness Rule (LiveProcess)
• MDLive will provide online medical consultations at no cost to patients affected by Hurricane Michael.
• Celebrating Health IT, Industry Collaboration and EHR Optimization (Medicomp Systems)
• Building a Mobility Team (With a Little Help From Mobile Heartbeat) (Mobile Heartbeat)
• Finding the Right EHR to Bring Your Strategy to Life (Netsmart)
• Expanding Access to Quality Home Healthcare Through Mobile Innovation (NVoq)
• Are You Prepared for an Epic Foundation System Refuel Project? (Parallon Technology Solutions)
• Why Are We in Healthcare; Raison D’etre, not D’etat (CloudWave)
• Match, manage, and protect patient data (Experian Health)
• Don’t Touch My Data!! (PatientSafe Solutions)
• 6 tips to improve the patient financial experience (Patientco)
• Let’s Set Our Sights on Advancing Healthcare (PatientKeeper)
• The Unsung Heroes – Case Management Week 2018 (PreparedHealth)
• Pharmacists Want to Play a Bigger Part in Patient Care Yet Are Hamstrung by Poor Access to Patient Data (Surescripts)
• Reducing alarm fatigue requires planning and education. (Voalte)
• Transforming Healthcare Communication to Improve Patient Care (Vocera)
• 7 Things to Do When Medicare Requests Your Patient Records (WebPT)

Contacts

Mr. H, Lorre, Jenn, Dr. Jayne.
Get HIStalk updates. Send news or rumors.
Contact us.

Weekender 10/12/18

Weekly News Recap

• Athenahealth is reportedly choosing from its options to accept acquisition bids from previously rejected suitors, sell out to NThrive, or continue as a going concern
• Several hospitals evacuate patients and suffer damage from Hurricane Michael
• The VA promotes Paul Tibbits to executive director for the Office of Electronic Health Record Modernization
• The DoJ clears CVS Health to proceed with its $69 billion merger with Aetna
• GE Healthcare’s former Value-Based Care Solutions Group, now owned by Veritas Capital, renames itself Virence Health Technologies
• Mayo Clinic completes the final go-lives of its $1.5 billion Epic implementation
• A study of 83 mostly top-rated hospitals finds that patients still struggle to get copies of their medical records

Best Reader Comments

Many states have information blocking (!) from their PDMPs. In fact, many state laws prohibit PDMP data from being exported outside the system to EHRs (it can only be seen in view-only mode on their web browser interface), making use in clinical decision support problematic. It’s not an issue of EHR vendor unwillingness, but rather that they can’t do an implementation if they can’t consistently get the data. (Harry Solomon)

Alerts seem like a perfect opportunity for an AI system rather than manual configuration files that will drive everyone crazy. (rxsdsu)

Tailoring every alert to each clinician requires work and maintenance far beyond the capacity, much less interest, of most IT departments. And, even people who rarely make mistakes still do make mistakes. Having a system that helps prevent that as a safety net is still relevant and helpful. I agree with you that too often a “one size fits all” policy is applied, which is inappropriate.  How much “tuning” can actually be accomplished is a yet to be seen outcome, but I’m not sure it is as much the hospital’s view of physicians as it is the financial and WorkStream reality we currently have. (Michael J. McCoy, MD)

As Warren Buffet has said, “When the tide goes out, it is easy to see who is swimming naked.” Jack Welch was really running a hedge fund within the GE Capital division. It accounted for over 50 percent of corporate profits many years. Everybody thought he was a management genius based on his PR announcements. Turns out he was nothing more than a hedge manager and the tide went out in 2009. He jumped ship and left the ruins to Jeff Immelt, who couldn’t turn it around for whatever reason. Now it looks like GE will follow many other firms like Xerox, Eastman, Alcoa, etc. Many years ago, I worked for GE and the inbreeding was smothering. (HISJunkie)

Totally agree with Mr. H about careers. Each time I was shown the door (boss conflict, downsizing, and failed salesmanship), I fell up to a better job, better pay, and more interesting work. Keep the resume ready, network all the time (it’s fun finding out who is where and what they are doing), keep records of your contacts, and keep reading HIStalk! (Laid Off)

Watercooler Talk Tidbits

Readers funded the DonorsChoose teacher grant request of Ms. J-J, who asked for tablets and a printer for her Georgia class (whose 18 students, she notes, include six English language learners and three who are homeless). She reports, “The tablets we received allow students to work independently in small groups on lessons and activities that help to increase learning and comprehension. The printer has also been a huge help because now we can send information about school and additional practice work home to parents without hassle. I am beyond thankful that my class was chosen and was able to benefit from the generous donation that you sent.”

Here’s a summary of how my DonorsChoose project works:

• I accept donations from individuals, but mostly companies willing to donate a significant sum in return for being included in my HIMSS-related activities, such as CIO/CMIO lunches.
• Donors place their donation directly with DonorsChoose and thus receive charitable donation documentation directly from that organization for tax purposes. I never touch their money directly.
• Their donation is matched by an anonymous vendor executive (who pretty much every HIStalk reader knows), doubling the original donation. That will continue until those matching funds are exhausted.
• I choose STEM-related DonorsChoose projects that resonate strongest with me, most of those involving additional matching money from foundations.
• I immediately describe on HIStalk the projects I chose, and when I receive updates and photos from the teacher involved, I post a summary. You don’t see them all right away since I run just one update each week, but I include all of them eventually.
• As an example of the buying power of a donation, the project above totaled $735, which includes $30 to DonorsChoose for doing all the labor and an additional 20 percent general donation to DonorsChoose that I always select. Of that, the matching offer from Arthur M. Blank Family Foundation covered $368, and of the remaining $368, half of that was provided by my anonymous vendor executive. The original donor’s $184 donation thus provided this classroom with six Kids Edition Kindle Fire tablets and a Xerox wireless printer.

A researcher says high-profile cases, such as the Golden State Killer, that were solved through DNA forensics prove that just about every American could be genetically identified if just 2 percent of us have our DNA tested through consumer sites such as MyHeritage and Ancestry.com. Such matching requires only a third-cousin or higher relationship and the authors say that “such database scale is foreseeable for some third-party websites in the near future.” 

Baylor St. Luke’s Medical Center (TX) threatened to punish an internist in “an assassination” in retaliation for his complaining about unnecessary services his patients received in the ICU. A private practice physician who serves on the hospital’s medical executive committee warned Tomas Rios, MD that “you’ve got to get the guy you’re going after and none of the people who were involved get implicated” and suggested that he resign instead. A hospital committee found Rios in violation of patient care standards just weeks later. The hospital says in response to his lawsuit that Rios is not a board-certified intensivist and opposes the closed ICU process that would place them in charge of all ICU patients, while legal experts have noted that hospitals have in some cases used peer review threats to silence doctors from speaking out about patient care issues.

Five New York City doctors are called “drug dealers in white coats” by the US attorney who has charged them with writing prescriptions for 5 million oxycodone pills to patients with no documented medical need who paid them $5 million. Neighbors called police several times to complain about lines of people at all hours outside of the office of one doctor who had two of his own employees, along with several patients, die of overdoses. Another doctor took in so much cash that he had to count it using one of those bill counters that banks use, after which he would hand out wads of cash to his employees. Another doctor prescribed 12,000 tablets for a single patient over five years. A pharmacist who received free lunches and a trip from a customer observed, “I guess you could call us licensed drug dealers. Oxy pays the bills around here.”

A Chinese tech site finds that fitness trackers will display a heart rate when wrapped around anything cylindrical, most impressively a roll of toilet paper or the arm of a stuffed animal. Apparently the light sensors that attempt to detect a pulse rate are easily confused by reflections, although they still read a human pulse accurately.

It’s all in the fine print: a small research study concluding that paper towels are better than air dryers in hospital handwashing was funded by the paper towel lobbying group.

In Case You Missed It

• News 10/12/18
• EPtalk by Dr. Jayne 10/11/18
• News 10/10/18
• Curbside Consult with Dr. Jayne 10/8/18
• Monday Morning Update 10/8/18

Get Involved

• Join my Rolodex to provide occasional news reaction or ideas
• Contribute regularly as a provider CIO, IT director, or informatics nurse (anonymous or not)
• Be interviewed (providers)
• Deliver an educational webinar (providers)
• Sponsor
• Report a news item or rumor (anonymous or not)
• Sign up for email updates
• Connect on LinkedIn
• Contact Mr. H

Morning Headlines 10/12/18

Athenahealth is reaching out to previously rejected suitors

The New York Post reports that Athenahealth is waffling between accepting acquisition bids from companies it previously rejected, merging with NThrive, or remaining as is.

2 Florida hospitals in wake of Hurricane Michael evacuating all of their 330 patients

Bay Medical Sacred Heart and Gulf Coast Regional Medical Center evacuate 330 patients after suffering extensive damage, including downed computer systems, during Hurricane Michael’s destructive trek through Panama City, FL.

Penn Medicine Launches Initiative to Transform Electronic Health Record Systems

Penn Medicine launches an internal EHR campaign that it hopes will get its Epic end users thinking about how to use the software more for care delivery than documentation.

News 10/12/18

Top News

Bay Medical Sacred Heart and Gulf Coast Regional Medical Center evacuate a combined 330 patients after suffering extensive damage during Hurricane Michael’s destructive trek through Panama City in the Florida panhandle. Damage to the facilities included a collapsed roof, cracked walls, blown-out windows, and in the case of Bay Medical, cooling and plumbing issues and loss of its information systems.

Bay Medical cardiologist Sam Patel, MD told the local news Michael’s winds were, in his experience, worse than Katrina’s: “The wind damage was pretty phenomenal. Windows were being blown in and water was coming in. Luckily, none of our patients had any injuries due to the storm. It was about two to three hours of pure hell.”

The category 4 storm, which achieved wind speeds of up to 155 mph, caused the closure of four hospitals and 11 nursing homes in Florida.

Webinars

October 30 (Tuesday) 2:00 ET. “How One Pediatric CIN Aligned Culture, Technology and the Community to Transform Care.” Presenters: Lisa Henderson, executive director, Dayton Children’s Health Partners; Shehzad Saeed, MD, associate chief medical officer, Dayton Children’s Health Partners; Mason Beard, solutions strategy leader, Philips PHM; Gabe Orthous, value-based care consultant, Himformatics. Sponsor: Philips PHM. Dayton Children’s Health Partners, a pediatric clinically integrated network, will describe how it aligned its internal culture, technology partners, and the community around its goal of streamlining care delivery and improving outcomes. Presenters will describe how it recruited network members, negotiated value-based contracts, and implemented a data-driven care management process.

Previous webinars are on our YouTube channel. Contact Lorre for information.

Acquisitions, Funding, Business, and Stock

TransUnion acquires revenue cycle vendor Rubixis in an effort to strengthen its post-discharge revenue recovery services.

Amazon patents speech analysis technology that may give Alexa the ability to detect illness and mood in a user’s voice, and then recommend and order products from Amazon’s marketplace. The patent filing also suggests that products and services from advertisers would be the first of Alexa’s suggestions.

The DoJ clears CVS Health to proceed with its $69 billion merger with Aetna, which will operate as a standalone business once the deal closes at the end of Q4. First proposed late last year, the deal gained steam after Aetna sold off Medicity in May, and is now contingent on the payer selling off its Medicare prescription drug Part D plans. It has gotten pushback from trade associations like the AMA, which believes the merger will negatively affect patients by offering them fewer choices and, ultimately, higher prices.

Government and Politics

The VA promotes financial management exec Paul Tibbits to executive director for the Office of Electronic Health Record Modernization. Tibbits takes over the role from Genevieve Morris, who resigned in August over differences with leadership in project direction.

NASA pilots Wolters Kluwer Health’s UpToDate clinical decision support software aboard the International Space Station. To work around spotty Internet connectivity, astronauts are using the MobileComplete version, which gives them the ability to download content for offline access.

Sales

• Sovah Health (VA) will implement lung cancer screening software from Eon at its Martinsville and Danville campuses.
• Cornerstone Hospice and Palliative Care selects Netsmart’s MyUnity EHR for post-acute providers.

People

AMIA will honor National Library of Medicine Director Patricia Brennan, RN with the 2018 Morris F. Collen Award of Excellence at its annual symposium next month.

William Turner (GovernmentCIO) joins Healthcare Management Solutions as chief strategy officer.

Announcements and Implementations

Penn Highlands DuBois (PA) goes live with tele-ICU capabilities from Advanced ICU Care that will connect its providers with specialists at UPMC.

Avera Health will use an $8 million grant to develop a behavioral health team at its ECare telemedicine hub in South Dakota. Virtual services will initially cater to ED and psychiatric hospital patients, then expand to first responders.

Urgent Care Group implements DocuTap’s EHR and practice management software at its MedCare Urgent Care facilities in South Carolina.

Surescripts sees utilization of its Record Locator & Exchange service jump 40 percent since launching last year thanks to increased adoption amongst Epic, NextGen, and EClinicalWorks users.

Northern Light Health’s A.R. Gould Hospital (ME) transitions to Cerner as part of what seems to be a nearly system-wide roll out that coincides with a rebranding from Eastern Maine Health System.

Good Shepherd Health Care System (OR) will go live on Epic next month through a $3 million sharing agreement with Legacy Health.

Other

Penn Medicine launches an internal EHR campaign that it hopes will get its Epic end users thinking about how to use the software more for care delivery than documentation. The transformation project will include an innovation tournament that will pair IT staff, data scientists, and clinical educators with clinicians to create software improvements.

Public hospitals in Melbourne, Australia rake in $45 million in car parking fees thanks to daily rates as high as $35, and government officials who don’t mind turning a blind eye despite promising to lower prices. The public’s outrage has also extended to Sydney, where its Eye Hospital has earned the dubious honor of charging the highest parking rate in the country – $64 for six hours.

Children’s Hospital of Philadelphia researchers use EHR data from its Epic system to develop an automated malnutrition screening tool that alerts providers to at-risk patients.

Cerner CEO Brent Shafer shows off his musical chops at the company’s closing night conference bash.

Military Makeover host Montel Williams credits the use of telemedicine by NYC paramedics with helping to save his life after suffering a rare type of stroke while working out in a hotel gym.

Sponsor Updates

• Primus Capital’s growth investment in Hayes will support continued development of its MDaudit Enterprise revenue integrity software.
• Elsevier provides point-of-care tools to NHS Wales in the UK.
• The EClinicalWorks National Conference attracts over 5,000 attendees.
• FormFast will exhibit at Health Connect Partners Hospital & Healthcare IT Conference October 15-17 in Chicago.
• Glytec publishes a new e-book, “Hypoglycemia in the hospital: Why is it costing you millions and what can you do?”
• Hayes will exhibit at the 2018 Revenue Integrity Symposium October 16-18 in Phoenix, AZ.
• Iatric Systems will exhibit at the HIMSS Healthcare Security Forum October 15-16 in Boston.
• InterSystems will exhibit at Healthcare Providers Transformation October 16-17 in Denver.
• The American Medical Informatics Association will induct Intelligent Medical Objects CEO Frank Naeymi-Rad, PhD, MBA into the American College of Medical Informatics.
• Kyruus will host the Annual Thought Leadership on Access Symposium October 15-17 in Boston.
• Meditech will host the 2018 Physician and CIO Forum October 17-18 in Foxborough, MA.
• AxialHealthcare will incorporate medication history from Surescripts into its analytics-based pain management software.
• Diameter Health earns ONC 2015 Edition Health IT Module Certification from the Drummond Group.
• PatientPing congratulates its national network of ACOs on generating shared savings of $270 million.

Blog Posts

• Bright Medical Horizons in Nashville (EClinicalWorks)
• User Story: Hospital IT Fixes 100’s of Citrix Print Issues (Goliath Technologies)
• Specialty-Specific Conferences: Food, Fun, and Face-to-Face (PMD)
• Four Ways Data is Disrupting the Healthcare Industry (Healthgrades)
• New Book from Next Wave’s Lynn Vogel Provides an Inside Look into the Complexity of American Health Care (Huntzinger Management Group)
• CRM for Healthcare Marketing (Influence Health)
• 4 ways integrated technologies are improving cancer care in Australia (Meditech)
• Examining Mergers and Acquisitions in Healthcare – Don’t Forget About the Patient (Loyale Healthcare)

Contacts

Mr. H, Lorre, Jenn, Dr. Jayne.
Get HIStalk updates. Send news or rumors.
Contact us.

EPtalk by Dr. Jayne 10/11/18

I was excited to hear that Atul Gawande, MD has been booked as the opening keynote speaker for HIMSS19. Many of us were initially enthusiastic about the efforts by Amazon, Berkshire Hathaway, and JP Morgan Chase to revolutionize healthcare delivery. That enthusiasm was somewhat tempered by the clarification that they’re really focused on solving the issue for themselves as employers, although it may eventually be extrapolated to the world at large. Regardless, Dr. Gawande has significant street cred in the healthcare trenches, and as a practicing physician, I’d much rather hear from him than from some of the other recent HIMSS headliners.

I was also excited to hear some information coming out of the American Academy of Family Physicians annual meeting this week. The American Board of Family Medicine used the meeting to announce a pilot program starting in January that will “assess the value and feasibility of a longitudinal assessment option to the 10-year secure examination.” Completing educational opportunities on an ongoing basis rather than cramming for an exam every 10 years is much closer to what we do every day in practice and was the preferred choice for recent exam-takers who were surveyed by the University of Florida in conjunction with ABFM’s assessment of the role of the exam. The questions will be administered quarterly and providers can use resources to find the answers, which better demonstrates our ability to manage knowledge rather than memorize.

I’m doubly excited since I have to recertify in 2019, although I already spent nearly $1,000 on a self-study board review course. The proposal still has to be approved by the American Board of Medical Specialties Committee on Continuing Certification in November. There aren’t any details on how large the pilot will be or whether everyone who wants to participate can actually take part, so I might still have to take the exam. I’ll be crossing my fingers, though.

The use of ride-sharing services as an alternative to ambulances for transportation to the hospital is getting some coverage in mainstream media. Data from 2011 shows that the US spent $14 billion on ambulance services, more than a third of which was paid for by Medicare. Inappropriate use is estimated at approximately 30 percent.

Although it sounds like a good idea from a cost perspective, I’ve found that in practice, patients don’t do the best job of determining whether an ambulance is necessary or not. We’ve had patients in the midst of active heart attacks at our urgent care who want to argue with us about an ambulance transport because of the cost. I’d hate to see someone in that situation summoning an Uber to their home because they’re worried about the money.

In order for this lower-cost transportation to be appropriate, patients are going to need education on whether it’s the right option for them. Maybe the ride sharing services need to add some screening questions to the app to not only help patients, but also to protect drivers from unwittingly picking someone up who needs serious medical attention. So far, what I have heard about Uber Health is that it will allow providers to order transportation, but doesn’t necessarily address the issue of patients trying to get rides on their own. I’m still up for some screening questions in the apps themselves.

Last week, the US Senate sent for presidential signature a bipartisan package fighting the opioid epidemic. The bill passed the Senate by a vote of 98 to 1, showing that political adversaries can and actually will cooperate when the circumstances are right. The only opposition was from Senator Mike Lee of Utah. The 600-plus page bill includes relaxation on Medicaid payments for inpatient treatment, increased surveillance on opioids being imported by mail, and allows certain midlevel providers to prescribe buprenorphine treatment. It doesn’t appear to have been signed yet, but I’m keeping my eye out.

The opioid bill is timed nicely with the release of the Surgeon General’s report on “Facing Addiction in America.” Assisting in management of opioid use (not only prescription, but illicit versions) is an area where EHR technology can be expanded for better support of clinicians. It’s not just about making it easy to link the EHR to the state prescription drug monitoring program (assuming the state has one, which one state does not) but in getting those links into the right part in the prescribing workflows and making the connections fast enough that they don’t impede provider workflow. It’s also about providing clinical decision support including morphine equivalents for drugs patients are already taking as well as those providers are considering for a new prescription. These should be relatively simple things to code, but don’t seem to be given much bandwidth on the development calendars of vendors.

It’s National Health IT Week, but I didn’t see a celebration in the physician lounge. Most of my local physician colleagues still see healthcare IT as a threat, not necessarily because of what it offers at face value, but because it’s a proxy for the perceived decline of medical practice as they used to know it. National Coordinator for Health Information Technology Don Rucker, MD blogged on the HIMSS site about how automation in healthcare is transforming medicine. Rucker talks a fair amount about the 21st Century Cures Act and its prohibition on information blocking.

Despite being signed into law in December 2016, it hasn’t done anything to improve information blocking in my region, which is largely due to competing health systems that refuse to share data even though they could do it fairly easily if they wanted to, especially now that all of them are on the same vendor platform. As an urgent care physician, I can’t even get their physician-owned practices to give me a medication list over the phone (despite the fact that it’s permissible under HIPAA for treatment, payment, and operations), let alone gain access to their clinical data repositories to find out what testing has already been done for patients before they arrive in my exam room.

Speaking of automation (or lack thereof), I’m still battling a billing issue with the hospital where I had emergency surgery over a year and a half ago. They sent me a bill last month for which I had no explanation of benefits document, which is unusual since I save every scrap of documentation around my healthcare. I hadn’t yet had time to call my insurance and see what the story was, but in the mean time, the hospital sent me to collections less than 30 days from the date of the statement.

I hopped on the phone to the payer, who had no record of a claim for that date of service, then had to call back to the hospital’s outsourced collections company, which provided me a supposed claim number. I called back to the payer to learn that the provided claim number didn’t even fit the standard format. They dug a bit deeper and found a charge for the same amount, but on a different date of service. It turns out it was paid, no one knows why I didn’t receive an explanation of benefits, and no one can explain why I was billed more than 18 months after the fact or why I was sent to collections less than 30 days after the bill was mailed. I paid my co-insurance online after sorting it all out, so hopefully this adventure is at an end.

What’s the longest running medical bill saga you’ve ever seen or experienced? What are you doing to celebrate National Health IT Week? Leave a comment or email me.

Email Dr. Jayne.