ONC chief expects rules ‘relatively soon’

With help from Darius Tahir (@dariustahir)

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Quick Fix

— ONC chief expects rules ‘relatively soon’: And other tidbits from this week’s HITAC meeting.

— Patients say they can’t afford to wait for privacy protections: Patients frustrated that they can’t easily access their own health data say information blocking directly impacts their health.

— How China’s using tech to fight coronavirus: Think catering robots, online education and apps to track the spread of the virus.

eHealth Tweet of the day: Ariella Hanker @AriellaHanker: Grant rejected. They liked the research plan; main complaint was that I don’t have grants where I’m the primary PI. (I wrote 95% of my last grant but was listed as co-I bc we thought we’d get a better score; it worked.) How am I supposed to get the first grant if that’s a prereq?

It’s FRIDAY at Morning eHealth. What are we missing? Let us know at [email protected]. Tweet us at @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

Driving the Day

HITAC APPROVES REPORT TO CONGRESS — Here’s what to know about ONC’s federal advisory committee meeting this week:

— Where’s the rule? The ONC rule outlining exceptions to the 21st Century Cures Act’s ban on information blocking is expected “relatively soon,” agency head Don Rucker told an inquiring HITAC member this week. Part of the challenge, he said, to “do this in a way that doesn’t prevent innovation ... and protects the public’s privacy ... .”

But ultimately the biggest issue, he added, remains “the vast amount of health care costs and the lack of patients having agency.”

The rule, which is under OMB review, has drawn sharp criticism from industry giants such as Epic, who argue that it doesn’t adequately safeguard patient privacy. Patients eager to access their data have called that view paternalistic, and see it as an attempt to preserve a status quo that gives software vendors more control over who gets data. Epic has called on HHS to delay finalizing the rules; patient groups and UCSF have urged HHS to finalize them as soon as possible.

Without sharing more details about the timing, Rucker emphasized that the agency is making “very solid progress.”

— Future FDA/HITAC collaboration? HITAC member Steven Lane floated the idea of a closer linkage between the advisory committee and FDA, especially on sharing adverse drug event data and incorporating it into health IT systems. (FDA’s Principal Deputy Commissioner Amy Abernethy joined this week’s meeting, where she described her efforts to shore up the agency’s internal IT.)

— Annual report approved: The committee approved by voice vote an annual report to Congress, incorporating some edits from members.

— New task force takes off: HITAC’s Intersection of Clinical and Administrative Data Task Force, which aims to support data use for clinical care, will hold its first meeting on March 3 and convene weekly until September.

‘KNOWLEDGE AS A HUMAN RIGHT’ — An increasingly vocal group of patients are pushing back against potential delays to the ONC proposal and a companion draft from CMS. Together, the two rules would force providers and insurers to make patient data accessible through APIs, so patients can send it to apps and digital health products they choose.

If finalized, the rules could give patients “unprecedented access to knowledge from HIPAA covered entities. My community needs that knowledge as a human right,” Andrea Downing, a patient advocate and security researcher, told Morning eHealth at Health Datapalooza last week. Downing co-moderates the BRCA Sisterhood Facebook Group, which has thousands of members.

But at the same time, she added, “we need to look at what happens the second something leaves a HIPAA covered entity.”

The privacy issues raised by powerful health technology vendors seem like a transparent effort to preserve business interests, she said. “We need to stop letting data holders with a financial interest either in blocking data from us, or exploiting data about is, from framing it as a zero-sum game. ... Nobody is representing the patients’ interests or rights.”

Downing was among more than 100 co-signers to awidely circulated letter to OMB led by patient Morgan Gleason, which, as we reported, urged ONC to finalize the rules as soon as possible. “We support advancing privacy protections that help keep patient data safe, but this should not come at the expense of sharing the information with our doctors or getting a copy of our own information – our data should move to where we want it to be,” it says.

AMID CORONAVIRUS OUTBREAK, CHINA TURNS TO TECH FOR DAILY ACTIVITIES — China is looking to apps, robots and online services both to help contain the spread of coronavirus and to help citizens carry out daily activities, Tracy Qu and Jane Zhang of the South China Morning Post report. A few examples:

— China’s State Council last week backed the launch of an app that tells users if they’ve been in proximity to anyone who’s reported an infection. The app draws on public transit records including trains and flights.

— AI companies such as Baidu and SenseTime are using algorithms to identify “maskless” to police people wearing masks in public places.

— Catering robot companies like Pudu Technology and Shanghai-based Keenon Robotics that started out filling a labor shortage in restaurants have expanded to hospitals, Tracy and Jane write.

— Hundreds of thousands of teachers have conducted online classes for 50 million students on Dingtalk, an Alibaba messaging app.

Europe

US CTO: EUROPE’S AI PLAN TOO BLUNT — The European Union’s proposal to create a two-tier classification system for artificial intelligence and regulate accordingly is too clumsy, U.S. Chief Technology Officer Michael Kratsios said Thursday during a talk at the Hudson Institute, our colleague Stephen Overly reports.

The EU proposal divides AI into high-risk and low-risk categories, and regulates the riskier technologies more closely. “We believe this sort of all-or-nothing approach is not necessarily the best way to approach regulating AI technologies,” Kratsios said.

The White House has been outlining high-level principles for regulating AI; health care agencies are still finding their way on oversight. FDA, for example, released a white paper last summer outlining the dilemmas of regulating a technology that, by nature, can evolve as it’s deployed. The agency is also holding a symposium next week on AI and radiology. ICYMI: Here’s Arthur Allen’s recent take on regulating clinical decision support.

ALSO IN EUROPE ... REGULATORS WARY OF GOOGLE’S FITBIT PURCHASE— The European Data Protection Board, the bloc’s umbrella group of privacy agencies, said this week that Google’s $2.1 billion deal to buy Fitbit may put people’s privacy at risk because of the search giant’s accumulation of reams of sensitive data, our POLITICO colleague Mark Scott reports from London.

“The possible further combination and accumulation of sensitive personal data regarding people in Europe by a major tech company could entail a high level of risk to privacy and data protection,” the group said in a statement following a meeting of regulators in Brussels.

“The EDPB reminds the parties to the proposed merger of their obligations under the GDPR and to conduct a full assessment of the data protection requirements and privacy implications of the merger in a transparent way,” the watchdogs said in reference to Europe’s new privacy standards, know as the General Data Protection Regulation, or GDPR.

The agencies urged Google and Fitbit to handle any privacy concerns before the European Commission reviews the deal for possible competition or other regulatory concerns, Mark writes.

... GDPR fines are coming: The head of Ireland’s privacy watchdog said companies would face fines for breaching EU law and that her office was looking to the United States for guidance on how big to make them, our POLITICO colleague Laurens Cerulus reports.

“A fine is an inevitability at some point,” Irish Data Protection Commissioner Helen Dixon told the Irish Independent in an interview but didn’t specify when any decision would be made.

Dixon added that her office, which oversees large tech firms including Facebook, Google and Twitter in the European Union, is looking at fines imposed in other parts of the world for guidance.

The U.S. Federal Trade Commission imposed a penalty of $5 billion on Facebook last July for violating privacy rights as part of the investigation into Cambridge Analytica.

On Tap

MEET THE NEW PERSONALIZED MEDICINE CAUCUS — Rep. Eric Swalwell (D-Calif.), Sen. Kyrsten Sinema (D-Ariz), Sen. Tim Scott (R-S.C.), and Rep. Tom Emmer (R-Minn.) are hosting their inaugural briefing to introduce Congressional Personalized Medicine Caucus on Feb. 26, from 11 a.m.-12 p.m. in the North Congressional Meeting Room of the U.S. Capitol Visitor Center (CVC 268).

What We're Reading

—A CBInsights report out this week delves into the WeChat app’s growing role in Chinese health care.

— Stat’s Rebecca Robbins profiles QBio, which aims to upgrade the physical exam.

— Molly Osberg and Dhruv Mehrotra dive into the privacy perils of online therapy apps for Jezebel.

— PLOS and the University of California have a two-year open-access publishing agreement, they announced in a blog post this week.