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March 10, 2020 News 2 Comments

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ONC publishes a six-page summary of changes that were made to the draft version of HHS’s interoperability rules in producing the just-released final version that took public comments into account:

  • Vendors have 36 months to release Electronic Health Information (EHI) Export that supports exporting a single patient’s data and exporting all patient data for users who are switching health IT systems.
  • FHIR Release 4 was chosen as the standard for API certification.
  • Health IT vendors are prohibited from restricting the sharing of screenshots and videos of their screens, but are allowed to limit such use to protect their intellectual property.
  • Compliance with the information blocking provision is not required until six months after the final rule is published and timelines for assessing civil monetary penalties will be determined later.
  • EHI is defined to be the HIPAA-designated record set starting in 24 months, but until then, it is the USCDI standard.
  • It will not be considered information blocking to notify patients that the apps they’ve chosen may or may not follow best practices.
  • An actor can require patient consent or authorization before providing access to EHI, but they must make reasonable efforts to provide a consent form.
  • An actor can limit the content of its response to requests to access, exchange, or use EHI without being considered information blocking, which allows them to negotiate terms.They can also fulfill requests in an alternative manner if they have technical limitations or can’t reach terms with the requester.
  • Fees may be charged for accessing, exchanging, or using EHI.

ONC will host a series of webinars that explain the new rules starting Wednesday, March 11.

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I asked Cerner to provide a high-level summary of what the new regulations mean for developers:

  • The appropriate open and unimpeded access, exchange, and use of EHI is firmly established. Information blocking is barred as a general rule.
  • Most favored nation behaviors and use of unlevel playing fields to favor some over others for participating in health information exchange will not be tolerated by HIT vendors.
  • HIT vendors will need to establish business practices that abide by five vendor-oriented exception conditions that set guardrails for fee development; non-discriminatory business practices; evaluating requests for access, exchange and use of EHI; and for responding to such requests in a good faith manner.
  • HIT vendors will need to embrace the era of the API as a critical basis for interoperability going forward, whether for enabling access by patients / consumers, for exchange of EHI with other providers, and for other needs for interoperability.
  • Current HIT vendors of certified HIT must keep their clients current by making available updated certified HIT capabilities for interoperability and the essential data set required for exchange (Version 1 of the US Core Data for Interoperability- USCDI) within 24 months for most requirements (36 months for EHI Export).
  • HIT vendors will need to attest to HHS and their certifying body as to their compliance with conditions of certification that assure most importantly that they will not engage in information blocking, provide real world support for interoperability, and that they will support API access for all verified registered users (including developers) who seek to connect applications to said APIs to access EHI held by an HIT vendor’s certified products

Reader Comments

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From Jake: “Re: coronavirus. The clinical director for a regional hospital in Oregon, which is undergoing a COVID-19 outbreak, is peddling rumors that the flu vaccine makes you susceptible and recommending $200-$500 immune system testing through her side business. Unconscionable.” Stefanie Haines – who has a BS in clinical laboratory science and a doctorate in healthcare administration – also owns the local fitness center, which is a member of a national chiropractic group that sells various snake oils, like vaccine detox. She uses her Facebook page to push debunked conspiracy theories about vaccines, promotes the fitness center’s own services, and claims that coronavirus is a deep state conspiracy that can be prevented by using her immune system tests and nutritional supplements. You will rarely be wrong if you assume that people and companies will do the most profitable thing over the right thing.

From Amtrakker: “Re: HISsies. Epic again? Seriously?” HIStalk readers did the nominating and voting as always, with me doing nothing except shelling out $99 for SurveyMonkey so I could tie ballots to the email addresses of HIStalk subscribers to prevent the ballot box stuffing that would be guaranteed with the typical online poll. I always hope for dark-horse winners to make my job more exciting than just copying Epic / Judy / John Halamka / KP / beers with Bush slides over year after year to announce the winners, but the majority rules.


HIStalk Announcements and Requests

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I’ll change out this week’s poll early since folks voted quickly, in which three-fourths of respondents said HIMSS did the right thing in cancelling HIMSS20.

New poll to your right or here: To what level are you avoiding crowded places and unnecessary travel due to COVID-19 concerns? I would not want to be in the cruise industry right now – I checked a couple of websites and the discounts are massive, such as an eight-day cruise on a highly rated ship for $299. Ships are still leaving ports, even Seattle, and returning to discharge petri dish passengers to go home all over the country.

I posted a list of sponsor virtual sessions that were repurposed from the lost HIMSS20. Most of them are, like their original counterparts, scheduled for this week. It’s a good time to get some desk-side education.

It is time (pun intended) to stop with “EST.” It will be “EDT” until November 1, or just “ET” if you want to wash your hands of the distinction in favor of a year-round replacement that prevents you from embarrassing yourself.


Webinars

March 25 (Wednesday) 1 ET: “Streamlining Your Surgical Workflows for Better Financial Outcomes.” Sponsor: Intelligent Medical Objects. Presenters: David Bocanegra, RN, nurse informaticist, IMO; Alex Dawson, product manager, IMO. Health systems that struggle with coordinating operating rooms and scheduling surgeries can increase their profitability with tools that allow for optimal reimbursement. This webinar will identify practices to optimize OR workflows and provider reimbursement, discuss how changes to perioperative management of procedures can support increased profitability, and explore factors that can impede perioperative workflow practices.

March 26 (Thursday) 12:30 ET. “How to Use Automation to Reduce ‘My EHR is Slow’ Complaints.” Sponsor: Goliath Technologies. A common challenge is that a clinician is ready to work, but their technology is not. EHRs can be slow, logins not working, or printers and scanners are offline. Troubleshooting these end user tickets quickly is nearly impossible, especially in complex environments that might include Citrix or VMware Horizon. This webinar will present real-world examples of how leading health systems are using purpose-built technology with embedded automation and intelligence to proactively anticipate, troubleshoot, and prevent end user performance issue across their IT infrastructure and EHRs.

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


Acquisitions, Funding, Business, and Stock

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HealthStream acquires 20-employee nurse scheduling app vendor NurseGrid for $25 million in cash. Nurses use its mobile app to manage their schedules, trade shifts, and communicate with each other, while managers use it to publish work schedules. HealthStream expects the money-losing company to contribute less than $500,000 to its revenue in 2020.

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Genstar Capital recapitalizes ConnectiveRx, continuing as the majority investor and bringing in new funds as minority participants. The company has doubled in size since Genstar’s initial investment in 2015.


People

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Philip Meer, MBA (Evariant) joins PatientKeeper as CEO.


Announcements and Implementations

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FormFast changes its name to Interlace Health.

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OptimizeRx adds COVID-19 related CDC alerts to its health network of EHR users.

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Intelligent Medical Objects partners with Perspecta and the Regenstrief Institute to integrate its Precision Patient Summary with the clinical data viewers of those organizations, which includes the VA through its use of Perspecta’s HealthConcourse.

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Salesforce announces enhancements to Health Cloud: provider management, provider search, provider relationships, an analytics solution for care management, and integration with Bridge Connector’s Destinations for integrating EHR data.

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Parkland Center for Clinical Innovation publishes “Building Connected Communities of Care: The Playbook for Streamlining Effective Coordination Between Medical and Community-Based Organizations.”

AMA will fast track development of a CPT code for coronavirus tests.


Government and Politics

Premier expressed satisfaction with the new ONC rule, but would like to see more security and privacy requirements implemented for third-party app vendors. They are also disappointed that CMS does not go further to reduce provider burdens, particularly with the new ADT Conditions of Participation requirements and their accelerated implementation timeframe.


Other

The American College of Healthcare Executives, America’s Health Insurance Plans, American Organization for Nursing Leadership, Future of Individualized Medicine, American College of Medical Genetics and Genomics, National Comprehensive Cancer Network, Congress on Healthcare Leadership, VMed, ACC, ENDO, and several other groups join HIMSS and AMIA in cancelling upcoming conferences due to COVID-19 concerns. Massachusetts has declared a state of emergency after 51 new coronavirus cases were found, with 70 of the state’s 92 cases related to a drug company’s 175-attendee conference in Boston last month.

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ICU doctors in Italy warn that government reassurances aside, conditions there have deteriorated as COVID-19 ramps up:

  • Hospitals are getting dozens of admissions for fever, breathing problems, and cough each day, all with positive swabs and all being diagnosed as bilateral interstitial pneumonia.
  • Up to 10% of cases are requiring ICU care for extended periods.
  • Hospitals that are overwhelmed at 200% of capacity have converted all ORs to ICUs and are diverting all other emergencies, including trauma and strokes (note: Italy has more physicians and hospital beds per capita than the US).
  • Hundreds of patients who have severe respiratory failure are being given nothing except a reservoir mask.
  • Patients who are over 65 or who have other medical conditions aren’t even being assessed.
  • The situation progressed from a few positive cases, then to some respiratory failures that took up ED resources, then to respiratory deterioration that filled ICUs.
  • Staff illness made it hard to cover shifts, while mortality from other causes then spiked because of lack of resources.
  • Doctors and nurses have infected their own relatives, some of whom are dying. 

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Former FDA Commissioner Scott Gottlieb, MD says it’s too late for COVID-19 containment and thus contact tracing is a waste of resources, predicting that more widespread testing will reveal existing large outbreaks. He says the next two weeks will be “very difficult” and urges shutting down movie theaters and other places where people gather indoors, requiring business to offer teleworking, and slowing transportation. He also says that while coronaviruses usually don’t circulate in the summer, nobody knows about this one. He says that March and April will be tough months, but the epidemic curve could start to go down at the end of April and the situation should improve considerably by summer. He says sporting events such as the NCAA’s Final Four may need to played in empty gyms and conferences should be cancelled: “Do you want to continue to hold conferences and have to run the risk that your entire attendee list is put into a quarantine because there was someone there who is infected?” He concludes that COVID-19 is a pandemic even though WHO is “not wanting to label it yet out of some odd sense of political correctness that I can’t fully appreciate.”

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Let’s clear those pre-HIMSS20 tweet buffers, folks (especially the HIMSS-employed ones).

It looks as though the “FHIR Festival” website has gone dark, which I assume is because HL7 and maybe HIMSS expressed minimal amusement at its use of trademarked terms. It was a parody site, which is legal to the extent that you can afford lawyers to argue your case. The good news is that it wasn’t really all that funny once you recovered from that initial small giggle from being caught off guard.


Sponsor Updates

  • Customers of professional liability insurer IronHealth can apply their risk management reimbursement dollars toward PeriGen’s PeriWatch Vigilance early warning system for labor problems.
  • Bright.md offers free coronavirus screening tool to hospitals.
  • Diameter Health adds new FHIR product capabilities to its data normalization and enhancement platform to enable payers and HIEs to share larger sets of data with other healthcare stakeholders.

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Currently there are "2 comments" on this Article:

  1. The final rule is here! And for all of the Epic-bashing on CNBC and the comments on this page, the ONC ended up implementing pretty much all the suggestions in Judy’s letter. If we go by editorialized headline logic, I guess that means the ONC now supports information blocking and making it harder for patients to access their records, since that’s what Judy’s letter allegedly advocated?

    Kidding aside, I trust others will offer their analysis of the weighty rules in coming weeks. But overall seems like a reasonable compromise to the USCDI dataset, allows EHR vendors to recoup some costs and protect IP, and will give patients and apps API access to considerable data with a path to expand the dataset in the future.

    The big thing that’s missing for me personally is any accountability for breaches of apps or app vendors. My reading of the summary is that app vendors will not be HIPAA covered entities even if they are accessing and storing PHI. ONC is basically waving their hands saying consumers and app vendors can figure this out for themselves with a Terms of Service agreement. Key language from the summary:

    “In effect, this places more of an obligation on the party requesting the EHI and the individual to attempt to satisfy the precondition byproviding a consent or authorization.”

    While this is good for data access, I full expect a medical industry Equifax/Facebook-CA 2.0 type situation at some point in the next few years, where vast amounts of PHI are leaked to the internet, and if you’re affected you get to submit a claim through a complicated website that will crash, and 8 to 16 weeks later you get a check for 47 cents. Takeaway: be careful what apps you give access to your data.

  2. Does the final rule cover image data? It looks like the USCDI does not include image files, but the HIPAA designated record set does. The only exclusions in 45 CFR 164.524(a)(1) are psychotherapy notes and information to be used in “civil, criminal, or administrative action or proceeding.” So in 24 months (March 2022?), the final rule can be assumed to cover image data (e.g. DICOM files) as well?







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