Today: FDA tackles medical device cybersecurity

With help from Arthur Allen (@arthurallen202) and Darius Tahir (@dariustahir)

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Industry and regulators alike are focused on the security and privacy of medical data this week. Health tech Twitter celebrated #DataPrivacyDay Monday with spirited patient protection discourse; today, some related concerns might make their way to Washington for an FDA meeting. Here’s what we’re watching:

— FDA tackles medical device cybersecurity: On their first day back after the government shutdown, some FDA employees on Monday saw formidable backlogs; the agency presses on today with a public workshop on protecting medical devices.

— Industry’s cyber gameplan: In advance of the workshop, health companies and providers offered their own recommendations for securing those devices.

— Upcoming meeting on clinical trials and tech: FDA Commissioner Scott Gottlieb said the agency would also call a future meeting on using real-world evidence in clinical trials.

eHealth Tweet of the day from Sen. Marsha Blackburn (R-Tenn.): @MarshaBlackburn It’s #DataPrivacyDay and I’m thinking about “Who owns the Virtual You?” Digital commerce has revolutionized our society - but how does it affect our privacy? Reply to this tweet and tell me your thoughts about your online privacy and how it should be protected.

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FDA TACKLES MEDICAL DEVICE CYBERSECURITY — The FDA is hoping to update its approach to medical device cybersecurity with today’s public workshop, where the agency will review draft guidance on the kinds of information developers would need to submit to demonstrate device safety. Morning eHealth’s Darius Tahir will be monitoring the two-day meeting, which includes a session called: “Preparedness and Response: Wanna Cry Again?” — a nod to the 2017 ransomware attack that targeted National Health Service hospitals in the UK.

INDUSTRY’S CYBER GAMEPLAN — Hospitals, providers, and other users of health IT and medical devices must continuously improve their security practices, a new report released Monday states. The report, from the Healthcare and Public Health Sector Coordinating Council’s cybersecurity working group lays security plan on health IT and medical devices ahead of today’s FDA meeting.

Consumers need to have security documentation which describes many of the technical ins and outs of their products; and organizations must have plans to patch and decommission old products that fall out of use.

... Speaking of security, an American man stole and published the names and HIV status of more than 14,000 people diagnosed in Singapore, The Wall Street Journal reports.

UPCOMING MEETING ON CLINICAL TRIALS AND TECH — Gottlieb says the FDA will convene a meeting examining how real-world evidence can be used in clinical trials, Darius reports. The FDA commissioner, who believes technology can speed up clinical trials, substitute for them or reduce their costs, spoke Monday at the Bipartisan Policy Center.

Using real-world evidence has private-sector appeal; companies like Apple and Google have built software enabling research studies into their respective smartphone operating systems. Researchers have been able to use that software to build studies examining diseases like Parkinson’s. Pros can read more from Darius here.

The deadline for comments on ONC’s clinician burden reduction draft has closed, and the usual players are weighing in: AMIA calls for more funding for documentation-related R&D ... AHIMA strongly believes health institutions should set policies on using copy-paste in the EHR, to prevent that function from propagating incorrect information ... MGMA suggests extending Stark and Anti-Kickback protections so that health systems can donate health IT and hardware ...

CALIFORNIA PRIVACY LAW ADVOCATE HEADED TO THE HILL FOR MEETINGS — Alastair Mactaggart, who was the driving force behind California’s landmark consumer privacy law, will hold meetings in Washington next week to urge lawmakers eyeing federal privacy legislation not to override state rules, our POLITICO Tech colleague Nancy Scola reports.

Mactaggart told POLITICO he’ll huddle with the offices of Democratic Sens. Ron Wyden (Ore.), Ed Markey (Mass.) and Richard Blumenthal (Conn.) as well as Gail Slater, President Donald Trump’s adviser on tech and telecom issues who’s acting as a White House point person on privacy.

Whether any new federal privacy legislation would override the laws of California and other states is a major sticking point in negotiations, according to those involved in the discussions.

Republicans have called federal preemption necessary to avoid a confusing patchwork of state laws, while many Democrats say federal privacy rules must be sufficiently robust to even consider that scenario.

Sen. Marco Rubio (R-Fla.) recently introduced a privacy bill that would override state laws. Mactaggart said he’s not yet scheduled to meet with Rubio’s office, but would be open to doing so.

SENATE HEARING ON HEALTH CENTERS — The Senate HELP Committee hearing on health centers in underserved communities is scheduled for 10 a.m. today. Staffers didn’t say if health IT would come up, though Chairman Lamar Alexander has long championed EHR reform.

... Alexander does plan to address the role community health centers have in increasing access to care and addressing the opioid crisis, according to his office. Earlier this month, Alexander and Sen. Patty Murray (Wash.), the panel’s top Democrat, introduced legislation that would extend federal funding for organizations providing care in underserved areas.

... House panel cancels shutdown hearing. The House Energy and Commerce Committee has canceled a hearing it had planned for Thursday, following the reopening of the government last week. Chairman Frank Pallone last week indicated the hearing would have looked at impacts to agencies like EPA, the Consumer Product Safety Commission, FTC, FCC and FDA. The House is not scheduled to be in session Thursday.

STARKS TO BE SWORN IN AS FCC COMMISSIONER WEDNESDAY — The Senate voted to confirm Geoffrey Starks to the open Democratic seat at the FCC earlier this month, and he’ll be sworn in Wednesday, our POLITICO colleague Margaret Harding McGill reports.

The swearing-in will take place ahead of Wednesday’s January meeting, the official said. The FCC last week said it will hold the meeting at 11 a.m., but it scrapped plans to hold any votes due to the partial government shutdown. The commission will host the meeting at agency headquarters, scrapping contingency plans for a conference call had the government remained closed.

The VA is recruiting a deputy chief medical officer at its Office of Electronic Health Record Modernization, which is overseeing the decade-long, multi-billion dollar effort to switch to Cerner’s EHR. Candidates should be able to "[s]hare best practices, processes, structures and policies with DoD” and "[m]anage and monitor budgets and productivity improvements,” according to a VA blog post.

— Sheelah Kolhatkar writes in the New Yorker on a whistleblower highlighting fraud within companies offering Medicare Advantage plans.

— NYT’s Aaron Carroll writes on pharmacists’ role in deprescribing drugs.