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Theranos rehashed, ARPA-H begins, & why the FDA can't regulate AI alone

 

STAT Health Tech

Four big ideas to change health care

We’re still processing all the news and ideas from the STAT Health Tech Summit last week — especially the big swings to transform care pitched by four health tech leaders. One standout idea came from Julie Yoo, general partner at Andreessen Horowitz: She wants to sell wearables makers on the concept of body batteries to head off what she sees as a looming power crisis for the growing number of health-tracking devices.

“One of the biggest contributors to the lack of compliance on the side of the patient with these longitudinal measurement programs is the need to recharge their device,” Yoo said on stage in San Francisco in a session moderated by Mohana. Pair that with a lithium shortage, and devices that can charge off of your own body heat start to look pretty good. Read the pitches the pitches from Bob Wachter at UCSF, Onduo CEO Vindell Washington, and insitro CEO Daphne Koller. 

Theranos whistleblower slams inaccurate portrayal

Many outlets have told the story of Theranos whistleblower Tyler Shultz. But Shultz said at the Summit that not all the accounts are accurate. Asked about the Hulu series “The Dropout,” Shultz said some of the scenes portraying him missed the mark entirely, including a shot where he is shown deleting fellow whistleblower Erika Cheung’s name on a complaint email she drafted and substituting his own. 

“First of all, that flat out never happened,” Shultz said, adding:  “(Erika) is an extremely bold person who’s perfectly capable of speaking up for herself, which she did.” In shooting down the inaccuracies, Shultz also laid out his lowest moments during the saga. “The bottom for me was definitely when I was being threatened with legal action,” he said. “...I was told that the only people I could talk to about this were my wife, my priest, and my lawyer — and I wasn’t married, and I’m not religious, and my lawyers are extremely expensive, so I really had no outlet.”  

Health care's future takes shape in DC

Radical innovation in health care has a new home. Last week, the Department of Health and Human Services officially established ARPA-H, a new NIH agency for moonshot efforts in biomedical science funded with an initial $1 billion. The agency also got its first acting deputy director, who will report directly to the HHS secretary: Adam Russell, chief scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security. Many details are still up in the air, including where all that innovation will be happening: Cities and states are lobbying to serve as its home base. 

Also last week, a bipartisan group of senators floated a bill to expand Medicare access to telehealth for mental health care. Coverage for telemental health is already in place — Congress made it permanent in 2020. But that provision, set to kick in once the pandemic public health emergency comes to an end, still requires Medicare beneficiaries to have seen their provider in person in the last six months. Telehealth companies have lobbied heavily to remove the restriction. Read more on the bill from Rachel Cohrs.

Opinion: FDA alone can't regulate AI

Plenty of health care stakeholders have pressed the FDA for a better system to regulate AI tools. But a new opinion piece in PLOS Digital Health argues that it’s going to take more than the FDA to oversee these technologies.  The public health researchers from Harvard call for a “distributed approach” to AI regulation that would require local institutions to take an active role in testing and monitoring AI tools to ensure they are used safely, effectively, and fairly.

That would require skills and infrastructure that do not yet exist in most health systems, including a dedicated team of AI specialists to develop standards and train clinicians on the use of AI. It would also require the use of local datasets to validate new tools and registries to track products in use. In short, health providers have to step up in a big way, the authors argue, because AI is simply developing too fast for the FDA to keep up.

The risks of AI without oversight

On a related note: AI can help counteract structural racism in health care, or it can perpetuate it in countless decisions made every day. The latest episode of STAT's podcast Color Code examines the origins and causes of algorithmic racism and a rising movement toward responsible AI. Listen to the full episode here.

Tapping new markets

  • CVS is launching a virtual primary care service. Built on a single digital platform, it will offer chronic disease management and mental health services, in addition to basic medical services. It will be available to Aetna members starting Jan. 1, 2023
  • Wearable device maker Oura is teaming up with Gucci to offer a high-fashion version of its ring to track a user’s heart rate, respiratory rate, temperature, and sleep. It’s 18K gold embossed with a Gucci logo, and retails for $950. So… no, they’re not exactly selling health equity.  
  • Medtronic and DaVita, a kidney care provider, have formed a new company to deliver more effective treatment for patients with kidney disease, such as tools to improve home-based dialysis care. Shares in the new venture will be equally split between Medtronic and DaVita.  

Do the CFO shuffle

  • Senior coordinated care company Clover Health named Scott Leffler as its new chief financial officer, starting in August. He previously was CFO at Sotera Health, a lab testing and sterilization company.   

  • Also filling a new CFO role is John Hofmann, who’s joining EHR company athenahealth after its $17 billion acquisition in February. Hofmann has previously served as CFO at technology companies focused on transportation (Omnitracks) and marketing (Infogroup).

What we’re reading

  • QR codes can help pharmaceutical companies in two big ways, STAT

  • Smarter health: Artificial intelligence and the future of American health care, WBUR 

  • Developing and validating a machine-learning algorithm to predict opioid overdose in Medicaid beneficiaries in two US states, The Lancet Digital Health

Thanks for reading! See you Thursday,

@caseymross, @KatieMPalmer, @mariojoze, @ravindranize
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Tuesday, May 31, 2022

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