By DARIUS TAHIR 03/23/2020 10:00 AM EDT
FDA is getting more active on the digital health front amid the coronavirus crisis:
— Coronavirus claims: The agency is easing enforcement on remote patient monitoring devices and clinical decision support software related to coronavirus, in a new guidance issued Friday. Such products, ideally, can allow providers to better manage patients from afar, keeping people from infecting or being infected.
For devices, manufacturers can make “limited” label modifications if those changes are related to coronavirus, though manufacturers will have to delineate which claims are FDA-cleared and which are expansions, along with providing data about the justifications for those claims. This might clear products intended for hospital use to be moved into the home, for example.
Manufacturers can also effectively turn on features, like wireless or Bluetooth, provided they build in cybersecurity controls.
Commenters on the guidance were bullish. Epstein Becker & Green digital health lawyer Bradley Merrill Thompson said in an email that the guidance is “very practical and doesn’t open the floodgates wide to potential fraudsters,” saying it should support “people looking for solutions in telemedicine and remote monitoring.”
— Test kit approvals, warnings: While the agency approved a rapid, point-of-care test Saturday, it also issued a warning to consumers: Test-at-home coronavirus kits aren’t approved. Judging by your correspondent’s groaning inbox, there are an awful lot of companies claiming they’ve got great mail-at-home tests — and perhaps consumers should be wary.
STIMULUS BILL UPDATE — Senate Majority Leader Mitch McConnell tried, and failed, to start the legislative machinery Sunday afternoon; as of this writing, it appears McConnell will give it the old college try again today. That means much of the legislative text is still in flux. Here’s the state of play:
— Senate GOP proposal: Senate Republicans proposed yet another slug of support for telehealth, as their plan would allow Medicare recipients to access telehealth even if they don’t have a preexisting relationship with their doctor.
And it turns up the dial on support for the VA’s network infrastructure buildout: Whereas the administration requested $1.2 billion, the bill would deliver $2.25 billion. The cash infusion would come amid multiple reports of VA employees struggling with the department’s sluggish network.
The bill also advances a long-sought goal of many in the health care industry: overhauling the privacy law governing substance use records, called 42 CFR Part 2. The law currently requires explicit patient consent every time data is shared within the health care system, and prevents sharing such data outside of it, for purposes like law enforcement investigations.
The GOP proposal would change the first part of the equation, allowing patients to consent once to sharing data within the health care system. After consent, the data is subject to HIPAA standards; patients can withdraw consent subsequently. And the proposal retains the old restrictions of use outside the health care system.
The legislative effort drew cheers from the longtime overhaul advocates, with the Partnership to Amend 42 CFR Part 2 writing, “This compromise alleviates the roadblocks” to connected care.
A Part 2 overhaul has gotten close before, passing the House but dying in the Senate in 2018. The key here is Democrats, many of whom have been cool on the proposal. Advocates are optimistic that this time, it’ll happen.
— Big picture on privacy: The privacy and security of patients’ data must be a cornerstone of any forthcoming coronavirus relief package, and the “waiver of any privacy protection must be intended to exclusively serve public health,” a coalition of civil-society groups told Congress in a letter sent to leadership on Friday.
The coalition — including Access Now, Amnesty International, New America’s Open Technology Institute, Public Citizen and nine other organizations — insisted that any pending legislation include cybersecurity protections to prevent breaches or other unauthorized disclosures.
“Any data processing or remote technology deployment should not minimize needed security protections in the context of pandemic response,” they said, adding that data ought to be “maintained in a secure environment and transmitted through secure methods.” Their other priorities included time limits on any privacy waivers, transparency about how data is collected and shared, minimization to protect patients’ identities and accountability for breaches and other failures.
IN THE STATES — Some states are stepping up their telehealth efforts:
— New Jersey: The state attorney general, Gurbir Grewal, has waived licensure requirements, allowing out-of-state physicians to provide services in New Jersey, our colleague Sam Sutton reports. Jersey is only the latest to make such a move; other big states, like Texas, have also taken this step.
— New York: The Empire State is encouraging residents to use telemedicine more as the hospitals begin to deal with the influx of sickened patients, our colleague Amanda Eisenberg reports.
“We know the vast majority of these patients who come in with Covid-19 are mildly symptomatic,” said Dr. Viraj Lakdawala, clinical director of virtual urgent care at NYU Langone Health. “We know that bringing them into the office or hospital isn’t going to change our management [of their care].”
IN THE ADMINISTRATION — The administration continues to struggle as the coronavirus crisis unfolds:
— Short-termism: The Trump administration is struggling with short-term thinking and "half-baked promises," our colleague Dan Diamond reports. Among those promises: the much-hyped Google website, which turned out to be far more limited than what the president initially touted.
Now the administration is huffing to catch up to the latest supply issues: specialized swabs for testing and personal protective equipment for health care workers.
— NIH halts much research: The National Institutes of Health is halting all non-mission critical lab operations to slow the coronavirus outbreak, the agency announced Friday. The institutes had already announced a pause in much of the in-person parts of the All of Us study, which is examining the effects of genetics longitudinally.
IBM, OTHERS TO UNLEASH SUPERCOMPUTERS ON COVID — President Donald Trump is tapping powerful supercomputing companies to help medical researchers discover treatments for coronavirus, our POLITICO Tech colleague Steven Overly reports.
IBM will lead the COVID-19 High Performance Computing Consortium, which will review research proposals on modeling the virus’ spread and prospective treatment. The effort comes as White House Office of Science and Technology Policy encourages the tech industry to contribute its computing power to the pandemic.