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September 26, 2019 News 11 Comments

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The FDA releases new draft guidance documents that cover the safe and effective use of digital health technologies, using a risk-based framework under its Digital Health Innovation Action Plan that addresses provisions of the 21st Century Cures Act. 


FDA will focus its enforcement on software that hasn’t been approved as a medical device but that offers clinical recommendations to providers without transparency about how it derives those recommendations. Examples are flu detection functions that use EHR data and location; software that identifies patients with potential opioid addiction; and machine learning algorithms that predict postoperative cardiovascular events in diabetic inpatients. These software functions do not allow providers to see the underlying logic that is being used and are therefore considered to be medical devices.

FDA will also review software that analyzes or manipulates medical images; designs custom orthopedic or dental implants; monitors physiological signs to predict heart attack or narcolepsy; measures lesions to predict malignancy; and that analyzes images to differentiate between stroke types.

FDA is also interested in software that issues caregiver alerts when detecting life-threatening situations that require immediate action, such as stroke.

Also on FDA’s list of clinical decision support as a medical device is software that analyzes sleep apnea monitor data; calculates insulin doses; and that analyzes genetic variants to issue patient-specific treatment recommendations.

FDA considers consumer technologies to be medical devices if they recommend lifestyle changes for insulin-dependent type 2 diabetics; recommend treatment options based on questionnaire answers; and advise parents whether to take a child to the ED.

Software will not be considered a medical device it if meets these four conditions:

  • It doesn’t process medical images or signals.
  • It doesn’t display or analyze patient information.
  • It makes recommendations to providers to help them make patient care decisions.
  • It enables a provider to see how and why it made a particular recommendation for a patient’s diagnosis or treatment.

FDA makes it clear that software that matches patient information to reference information is not a medical device, such as displaying practice treatment guidelines; issuing warnings for drug-drug interactions and drug-allergy contraindications; checking drug or device orders to see if they follow FDA labeling; recommending additional tests or interventions; and calculating nutritional needs.

Comments on the proposed clinical decision support-related rules are due by December 26, 2019.

Reader Comments

From Going Epic: “Re: RWJ Barnabas. Has 90+ jobs listed that require Epic experience.” Reader Barnabas Rubble said back in a June rumor that they would be replacing Allscripts and Cerner with Epic, although CIO Robert Irwin ignored my resulting inquiry. You have to wonder what Northwell Health is thinking since they are one of few big US Sunrise sites left and they are supposedly making a keep-or-dump decision in the next few weeks. UPDATE: an equities analyst noted that while Allscripts said in its most recent earnings call in talking about new Sunrise sales that “extending and expanding” at Northwell is being decided soon, he thinks that its Sunrise and TouchWorks agreements were extended last year and run for several more. He’s thinking that it’s the IT outsourcing agreement that is expiring and thus being discussed. I think he is correct as I re-read the Q3 2018 earnings call transcript, in which Rick Poulton says that Northwell extended its TouchWorks agreement for five more years, the managed services  agreement is up for renewal but isn’t a high-margin business anyway, and Sunrise wasn’t specifically mentioned. Readers who know more are welcome to chime in. Thanks for the correction.

From Insider: “Re: Cantata Health. Continues to purge employees who have been around since the Keane days. They have abandoned the acute market, with NetSolutions as their only viable product under new leadership.” Unverified. A private equity firm acquired the health IT assets of NTT Data to form Cantata Health in 2017. The company’s website continues to list Optimum.

From Exec Checking In: “Re: your site. My onboarding with a very large global firm required me to sign up for HIStalk updates. It’s the only email I always click on. I have to be up to date on industry news at all times and your site is my best source.” That comment made my day, thanks. I like being required reading, although having people following me voluntarily is even better.

HIStalk Announcements and Requests


Welcome to new HIStalk Platinum Sponsor OpenText. The Waterloo, ON-based company’s cloud and on-premise Enterprise Information Management products for healthcare drive interoperability, improve information access, eliminate paper documents, and enable data-driven decisions. Among its solutions are RightFax (paperless, secure faxing that creates an organization’s most-connected device with minimal disruption); MedNX (lab report distribution); EMR-Link (lab and imaging orders and results integration and outreach); Intelligent Forms Automation (transition to digital processing); Documentum (information asset management); TeleForm (document-driven workflows); Covisint MIPS reporting; and Magellan (analytics and AI). Banner Health uses the company’s EnCase EDiscovery and EnCase Endpoint Investigator to assess potential cybersecurity issues and to respond accordingly, while Lahey Health uses Documentum to present outside unstructured clinical data within Epic with a single click. Thanks to OpenText for supporting HIStalk.

I noticed that a distant relative is working for a small-town behavioral and substance abuse facility whose website talks about “empowering people” and “putting clinical excellence above all else.” Corporate sleuthing reveals that, like much of healthcare these days, the organization is part of a chain owned by a private equity firm.


October 2 (Wednesday) 1:00 ET. “Conversational AI in Healthcare: What About ROI?” Sponsors: Orbita, Cognizant. Presenters: Kristi Ebong, SVP of strategy and GM of healthcare providers, Orbita; Matthew Smith, AVP and conversational AI practice leader, Cognizant. Conversational AI holds great promise to drive new opportunities for engaging consumers and customers across all industries. In healthcare, the stakes are high, especially as organizations explore opportunities to leverage this new digital channel to improve care while also reducing costs. The presenter experts offer a thought-provoking discussion around conversational AI’s timeline in healthcare, the factors that organizations should consider when thinking about virtual assistants through chatbots or voice, and the blind spots to avoid in investing in those technologies.

Previous webinars are on our YouTube channel. Contact Lorre to present your own.

Acquisitions, Funding, Business, and Stock


Veteran health IT communications executive John Hallock shares insight into the PR run-up to the Athenahealth and Livongo IPOs, stressing that hard data helped craft a narrative that attracted the attention of investors, media, and influencers. Hallock’s comms resume also includes stints at Imprivata, CareCloud, and Change Healthcare.


Best Buy expects to take in $50 billion in revenue by 2025, a move that will be driven in large part by a more aggressive push into senior-focused home healthcare services. The next five years will see the company scale its remote monitoring devices and services through its Geek Squad unit and partner with additional payers to add care coordination services.


Digital stethoscope and ECG technology company Eko raises $20 million.


New Mountain Capital acquires Nashville-based healthcare technology, services, and consulting company Emids for an undisclosed sum. Analysts have speculated that the purchase price is between $200 million and $225 million.


GoodRx adds virtual visits to its prescription drug discount website and app after acquiring telemedicine company HeyDoctor.


Sam’s Club partners with Humana to offer Care Accelerator, health-related discount bundles that include free prescriptions for popular generics, unlimited $1 telehealth visits, dental discounts, free lab tests, and prepaid health debit cards.


  • Tenet Healthcare signs a new multi-year agreement with NTT Data Services for application, infrastructure and security support and development services


image image image image

Greenway Health names David Cohen (Cerner) SVP of product management, David Millen (R1 RCM) SVP of product development, Sri Rajagopalan VP of architecture (SAP America), and Sagy Mintz (Allscripts) VP of quality assurance.

Announcements and Implementations


A KLAS report finds that Cerner customers are more satisfied with advisory and implementation consulting services obtained from third-party firms than those provided by Cerner itself. Firms such as PwC, Atos, and Emids — which sometimes are engaged to fix a struggling Cerner implementation — had zero dissatisfied respondents. Customers complained that Cerner sends inexperienced fresh graduates while third-party firms not only decline to hire inexperienced employees, they often bring on former Cerner people. Customers also report that Cerner lacks a prescriptive implementation methodology, its consultants don’t talk to each other, and high costs and estimate overruns leave customers feeling that they aren’t getting their money’s worth.


CoverMyMeds announces GA of AMP: Access for More Patients, an automated specialty prescription access and adherence support tool for patients developed with parent company McKesson.


Relatient adds secure two-way messaging between patients and providers to its patient engagement software.


Wolters Kluwer Health adds clinical natural language processing capabilities to its Health Language data extraction and integration software.

Government and Politics


The VA’s OIG finds that its providers aren’t checking PDMPs regularly, placing patients who take opioids at risk because they don’t see their non-VA prescriptions.


The Chalmers P. Wylie Ambulatory Care Center in Columbus, OH will become the first VA facility to replace Epic scheduling with Cerner next April, coinciding with the VA’s rollout of Cerner at facilities in the Pacific Northwest.

Sponsor Updates

  • AdvancedMD will host its global user conference, Evo19, October 2-5 in Orlando.
  • Elsevier Clinical Solutions will exhibit at the Emergency Nursing Association event September 29-October 2 in Austin, TX.
  • EClinicalWorks will exhibit at the APHCA Annual Conference October 1-3 in Gulf Shores, AL.
  • Ellkay and Healthwise will exhibit at AdvancedMD Evo19 October 2-5 in Orlando.
  • Goliath Technologies publishes a new solutions brief, “Goliath Technologies + IGEL: Improving patient care through proactive, fast and secure delivery of clinicians’ digital workspaces and EHR applications.”
  • Redox will host its third annual Healthcare Interoperability Summit October 15 in Boston.
  • Meditech maintains its momentum in the Canadian EHR market with 47% market share and a number of new customers and product expansions.
  • ITether adds access to Healthwise’s evidence-based curriculum to its outpatient care coordination and patient engagement software.
  • GetWellNetwork collaborates with Cerner to improve care coordination and patient engagement before and after hospital admission.
  • The Chartis Group publishes a new paper, “How Does Your Physician Enterprise Measure Up?”
  • StayWell’s My StayWell Platform and Krames on FHIR and Krames On-Demand products achieve ISO 27001:2013 certification for its information security management system.
  • Mobile Heartbeat collaborates with Eisenhower Health (CA) to improve emergency response communication.

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Mr. H, Lorre, Jenn, Dr. Jayne.
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Currently there are "11 comments" on this Article:

  1. In response to Cerner and KLAS … I’m to the point where, before I get service done at your facility? I asked what EMR it is… if it’s Cerner, I go somewhere else

  2. University Hospitals (in Cleveland area) also uses Sunrise and doesn’t seem to have any plans to migrate off. I don’t think there are any other health systems out there that don’t have a plan to migrate.

  3. I really appreciate your penchant for the correct use of grammar and spelling. Your caution on the proper use of EDT versus EST are duly noted. However, in the last several HIStalks, I’ve noticed your own oversight. The correct spelling of MEDITECH is all caps, not “Meditech”. Just making a small respectful observation.

    • I follow AP Stylebook, which says company names should not be capitalized unless they form an initialism (such as IBM). The Boston Globe doesn’t capitalize Meditech, either, for the same reason. The guide is:

      Do not use all-capital-letter names unless the letters are individually pronounced. For example, “BMW.” Other should be uppercase and lowercase. For example,

      Ikea, not IKEA
      USA Today, not USA TODAY
      Do not use symbols such as exclamation points, plus signs, or asterisks that form contrived spelling that might distract or confuse a reader. For example,

      Yahoo, not Yahoo!
      Toys R Us, not Toys “R” Us
      E-Trade, not E*Trade

  4. RE: FDA CDS rules

    If enacted, looks like a few possible outcomes might be:

    1. Major hiring push at the FDA
    2. Lagging approvals of CDS
    3. Lagging drug approvals since the staff are now working on CDS

  5. RE Spelling
    Me I’m offended by those “CVS/Pharmacy” signs. Any DOS nerd knows CVS is a subdirectory of the all pharmacies, so it should be “\Pharmacy\CVS”.

    • You had me at “DOS nerd”. But as DOS nerds know, DOS used a FAT-16 filesystem that didn’t recognize lower case letters.

      Therefore, the right answer is “\PHARMACY\CVS”.

      Being technically right is the best kind of right!

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