December’s heavy health IT agenda

With help from Darius Tahir and Mohana Ravindranath

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END OF THE YEAR REG-DROP FESTIVAL: As we enter the final month of 2018, the federal agencies of interest to the health IT world are pregnant with developing rules. The following measures are under review at OMB’s Office of Information and Regulatory Affairs, which generally has 90 days before returning rules for agency release. Listed by extent of pregnancy:

— ONC 21st Century Cures Act interoperability, information blocking, and the Health IT cert program (submitted on Sept. 17)
— CMS Interoperability and Patient Access rule (submitted Sept. 21)
— Office for Civil Rights: Request for information on changes to HIPAA to support coordinated care (Nov. 13)
— CMS Medicare Shared Savings Program; Accountable Care Organizations (Nov. 30)

Other pending rules, RFIs and guidelines, etc., that may see developments in December (h/t to Jeff Smith, vice president for public policy at the American Medical Informatics Association):
— NIH Data Management and Sharing Plan RFI
— CDC National Test Collaborative RFI
—NIST Securing Telehealth Remote Patient Monitoring Ecosystem White Paper
—NIST Privacy Framework
—OIG — Medicare fraud anti-kickback law reform
—FDA NPRM on Consent Alignment with Common Rule

“Depending on your viewpoint,” Smith says, “There are either a lot of presents under the Christmas tree or a lot of coal in your stocking.”

WHITE HOUSE WELCOME WAGON: The White House is hosting an “executive forum on health care data interoperability” Tuesday afternoon. We know of various EHR vendors, health care executives, interoperability mavens and other usual suspects who have been invited. The Holiday Season event kicks off with remarks from CMS Administrator Seema Verma and ONC chief Don Rucker, who presumably will not share that much about their big rules at OMB.

... After that, the guests in their finery will hold “breakout sessions.” Let’s hoping there is punch, peppermint bark, and mistletoe — under which providers, vendors and payers can kiss and make New Year’s resolutions!

… People, you have two hours to create a beautiful, intricate data sharing patisserie. On your mark, get set, bake!

Tweet of the Day: Farzad Mostashari @Farzad_MD Many deaths occur within MINUTES of discharge. I remember mapping the locations of all OD ambulance runs in NYC, and there was a tiny area in Long Island City with rates that were just unbelievable. It was where the bus from Riker’s Island would drop off released inmates

Welcome to Monday’s Morning eHealth. Across the nation and the world, smart health IT nerds are looking up from steaming coffee mugs, sighing with satisfaction and mouthing the immortal words, “consolidated clinical document architecture.” Send tips to [email protected], and don’t forget to mention us in your tweets: @ravindranize, @arthurallen202, @dariustahir, @POLITICOPro, @Morning_eHealth.

GETTING ALL OF US TO ALL OF US: To create what could be the largest, most diverse biological and social database of humanity in history, NIH has a largely non-technical challenge: convincing people who distrust government research to hand over their blood samples and electronic health records.

... NIH’s All of Us project aims to recruit one million participants whose medical and lifestyle data could help researchers investigate a wide range of conditions, a key building block of precision medicine.

... In the early stages of enrollment, NIH has two main strategies for reaching groups historically underrepresented in medical research: using targeted in-person and online messaging to appeal to specific community values, and rewarding participants with detailed insights about their own health.

... Morning eHealth’s Mohana Ravindranath explores NIH’s methodology for breaking through the wall of mistrust here for Pros.

MORE FROM ONC ANNUAL MEETING: The long-awaited rulemaking that would define exceptions to the 21st Century Cures Act’s ban on information blocking won’t interfere with HIPAA and will consist of “largely common sense types of things,” ONC head Don Rucker said at the final day of ONC’s annual meeting Friday. Rucker told audience members during a keynote that anyone charged with making that rule “would come to something similar,” Mohana reports from the scene.

... ONC Chief Clinical Officer Andrew Gettinger said the agency will spend the next few months reviewing feedback on its just-released draft strategy for reducing clinician burden from health IT. The feedback, review and rule clearance process would take until at least the spring, but predicted a final strategy release some time in 2019.

VA EXPANDS TELEMEDICINE: The agency announced Friday that it has established a tele-counseling service within its Vocational Rehabilitation and Employment Program.

FDA AWARDS DEVICE MAKERS: —Eight medical device makers, including two IT companies, won an opioids-related innovation contest sponsored by the FDA. CognifiSense, which is developing a virtual reality therapy, and iPill Dispenser, which uses a biometrically controlled mobile app to cut overconsumption of pills, were among the winners. More details here.

FDA PRE-CERT GUIDANCE SLIPS: It may come in January, digital health leader Bakul Patel said on Thursday. FDA wants to incorporate comments on its current pilot before moving to the second stage of the program, he said. The agency has been working with software developers such as Apple and Johnson & Johnson on the pre-certification pilots since last year. During the next stage, the agency will create methods to assess the performance of products from pre-certified companies after they enter the market and tweak the level of review needed for them, Patel said. More from Darius Tahir’s story here.

SOME COMMITTEE RANKING MEMBERS FOR YOU: The House Republican Conference on Friday ratified the following 116th Congress ranking members of interest to health IT folks: Appropriations: Rep. Kay Granger (TX-12); Armed Services: Rep. Mac Thornberry (TX-13); Budget: Rep. Steve Womack (AR-03) ; Energy and Commerce: Rep. Greg Walden (OR-02); Veterans’ Affairs: Rep. Phil Roe (TN-01) Ways and Means: Rep. Kevin Brady (TX-08)

KUSTER TO THE RESCUE: Rep. Annie Kuster (D-NH), a leading Democratic voice on the House Veterans Affairs Committee, was elected Friday to vice chair of the centrist New Democrat Coalition of 90 members of Congress.

Tuesday
9 a.m. Health Affairs telehealth briefing

Wednesday
noon AMIA and AHIMA briefing on patient data

A Federal New Network perspective on what the VA is doing wrong in its Cerner implementation.

A profile of Kerstin Arnold, who may be the single most important Texas lawyer involved in the opioid epidemic as general counsel of the Texas State Board of Pharmacy

Article in Current Anthropology explores the military’s effort to “kill-proof” its soldiers with biomedical armor

Axios does a deep dive on the ‘new digital divide’ that’s actually pretty interesting.

An argument in Forbes for the significance of Amazon’s move into health natural language processing.

In BMJ, What happens when the world’s biggest medical device maker becomes a “health services provider”?

Journal of the American Heart Association article on creating a prognostic tool for patients with peripheral arterial disease using data elements auto-extracted from an EHR