Inspectors general plan joint audit of VA/DOD interoperability

With help from Arthur Allen (@arthurallen202) and Mohana Ravindranath (@ravindranize)

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Quick Fix

— Inspectors general plan joint audit of VA/DOD interoperability: Agency wathchdogs plan to do a joint audit on the Cerner EHR system’s interoperability potential.

— FDA gets a snapshot on AI regulation: The agency is going to have to very carefully regulate the use of artificial intelligence in radiology.

— Verma acknowledges senators’ diabetes program letter: The CMS administrator said in a newly reported letter her agency is exploring how to include virtual DPP in Medicare.

WEDNESDAY: Your correspondent is pretty excited to watch Zion Williamson (try to) dunk on LeBron. Discuss dunks by email at [email protected]. Talk dunks socially @dariustahir.

eHealth tweet of the day: Bob Herman @bobjherman “Notable exceptions from today’s stock market beating: Domino’s (up 2 percent) and Teladoc (up 4 percent). Coronavirus apparently means staying indoors and video chatting with doctors about why we don’t feel so hot from our new all-pizza diets.”

Driving the Day

INSPECTORS GENERAL TO AUDIT CERNER EHR — The Pentagon and VA inspectors general are set to assess the system’s interoperability, the watchdogs said in a letter.

The departments’ EHRs will more readily share data if they’re closely aligned in their design. But providers will want systems to be customized for their specific needs.

The Pentagon’s EHR launch was marred by reports of safety problems. The Veterans Affairs Department has delayed testing of the new Cerner EHR, intended for the Pacific Northwest, citing an incomplete product.

FDA GETS A SNAPSHOT ON AI REGULATION — How should FDA regulate AI in radiology? Very carefully, if you believe experts and industry representatives who spoke at an agency workshop on Tuesday.

The performance of AI can depend tremendously on context — say, whether a polyp is flat or raised, said Ronald Summers, a senior radiology scientist at NIH. The results may be inexplicable, and AI systems can be brittle — lacking consistency across datasets or different types of imaging hardware.

One big conundrum stems from how health systems deploy AI to read images. They can set error thresholds lower — and run the risk of false negatives — or high, producing more false positives that human radiologists will have to carefully examine, which sort of undercuts the whole purpose.

It’ll be safer to set them high. “It’s not unreasonable to expect superhuman performance from AI,” said Keith Dreyer, chief data scientist at Partners Health. “Each false negative could represent a loss of life.”

Despite the poor job radiologists do reading mammograms, for example, “we may be more comfortable with human error than we would be with computer error,” said Constance Lehman, chief of breast imaging at Massachusetts General Hospital.

There were optimists in the crowd as well. Software will produce bad results sometimes, but clinicians can catch them, said Bibb Allen, chief medical officer of the American College of Radiology’s Data Science Institute. Judgement, after all, is the humans’ job. “AI is kind of like my dog,” he added. “It’s pretty non-judgmental.”

— One takeaway: FDA invited comments and asked participants whether it should issue guidance for AI in radiology submissions.

VERMA ACKNOWLEDGES SENATORS’ DPP LETTER — CMS is “currently exploring ways” to allow virtual providers of the diabetes prevention program to gain Medicare reimbursement, agency administrator Seema Verma wrote to senators in a newly-reported January letter.

The Verma letter is a response to an October missive from a bipartisan group of 19 senators over whether the agency was working on changes to accommodate the providers – who might fill in some of the gaps left by the in-person version. Many cities lack convenient access to providers.

The back-and-forth comes amid perceptions of stagnation around the program. Previous reporting by POLITICO showed that mere hundreds of Medicare beneficiaries accessed the benefit in 2018 when tens of thousands were expected to.

BETTER DATA SHARING FOR RESEARCH — A new policy agendafrom ONC sketches out a world in which the IT systems hosting clinical information and research can seamlessly exchange data.

The agency outlines several policy priorities to make sure information can reach interested researchers, including improving data quality at the time it’s captured, and to improve data aggregation tools. Officials paired the release with dual pieces in JAMIA, both outlining the agenda and detailing support from agencies including FDA, NIH and the Veterans Health Administration.

AMA’S DATA SHARING PLAYBOOK — The big physicians’ group been working on its new patient data sharing playbook long before ONC and CMS released their data sharing draft proposals, association board chair Jesse Ehrenfeld told Morning eHealth.

But some of the questions it aims to answer — such as how much providers can charge, and when certain privacy laws apply — may become more urgent as those rules are finalized and implemented, Ehrenfeld said. ‘

The national conversation pitting patient privacy protections against access creates a “false dichotomy,” and Ehrenfeld said he hoped the playbook demonstrates to patients and physician how it’s possible to share data with patients safely today.

“I get asked all the time by colleagues very simple things [like] ‘Is it okay to use text messaging to share information?’ There’s nothing in HIPAA that says that you can’t. There need to be policies and practices around that but it really needs to be driven by the patient,” he said.

“What we don’t want to see is physicians, or other health care providers or facilities hunker down and take the path of most resistance that inhibits the ability for information to be shared with patients because they’re confused.”

Health IT Business Watch

BIZ NEWS — Health tech had a busy few days:

— Apple/J&J heart study: Apple, Johnson and Johnson, and startup Evidation are embarking on a three-year, randomized, 150,000-patient study to see whether the combination of an iPhone, an Apple Watch, and an app can help senior patients avert stroke. The study will test the Watch’s atrial fibrillation detection feature, and the Heartline app’s engagement features.

The Apple Watch, as we’ve previously noted, has been rolled out over a massive population with uncertain prospects. Atrial fibrillation is clearly problematic for many patients, but it’s unclear whether detecting the condition in younger, asymptomatic users — the population left unexamined by this study — is helpful.

— Aetion partnership: Aetion, a startup specializing in real-world evidence, is partnering with Institute for Clinical and Economic Review, the organization best-known for its cost-effectiveness assessments for drugs. The organizations say that Aetion’s rapid generation of real-world evidence from actual clinical practice will help complement the clinical trial evidence.

— EU official: privacy regulators not part of Fitbit/Google review: EU official Margrethe Vestager, the union’s top official on competition, said that privacy regulators won’t play a part in the merger review between Fitbit and Google, our colleagues reported. The EU’s privacy protection board had – like many privacy hawks – said the deal poses risks for users’ privacy.

PERSONNEL NOTES — Sara Singleton, formerly of the Cystic Fibrosis Foundation and the Obama-era HHS, is joining Leavitt Partners to advise on social determinants of health issues, our Influence colleague Theodoric Mayer reports.

What We're Reading

Ronny Jackson, the erstwhile nominee to run the VA, is having a rough go running for Congress in Texas, the New York Times reports.

Consumer Reports reveals how GoodRx shares data with social networks.

Bloomberg goes deep on the rise and fall of consumer genetics testing firms.