Med devices need to show the FDA their cyber plan

Hidden in this year's federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid, lies a mandate to protect medical devices from hacks or ransomware attacks.

The law, which went into effect yesterday, explicitly states that companies cannot sell Internet-connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan. It also gives the FDA $5 million to see a higher security standard through. Historically, the agency has lacked the resources to keep up with rapidly-evolving security threats, or the authority to force device makers to comply with its draft guidelines.

"FDA is not going to have to argue with people anymore," Naomi Schwartz, senior director at Medcrypt and former reviewer at the FDA, told me.

Yesterday, the FDA announced it won't officially exercise this authority until October 1. Over the next six months, the agency will work collaboratively with device makers to help them meet the FDA's standards. After that, the FDA will start rejecting devices that do not adhere to the new cybersecurity law.

digital health

Oscar Health taps former Aetna executive for CEO job

Tech-foward insurer Oscar Health has named former Aetna CEO Mark Bertolini to be its new chief executive. Bertolini, who most recently helmed the hedge fund Bridgewater Associates, has been advising Oscar over the past 18 months on how to better incorporate digital services and analytics into the insurance industry.

"I'm returning to the health care industry because I believe there is still work to be done," Bertolini said. At Oscar, that work will include pushing toward profit — the company last year reported a loss of about $610 million on $4 billion in revenue. Read more here.

medical devices

Coming up: Medical device innovation webinar

The Medical Device Innovation Consortium is hosting a webinar today about using computational modeling and simulation to design and develop medical devices. The idea is that developers can better and more efficiently predict device performance by building a digital simulation of how the device would work. This practice can help reduce production costs and speed up time to market, according to the consortium. But companies rarely include computer modeling in their regulatory submissions.

The panel includes speakers from Boston Scientific, Dassault Systèmes, Zimmer Biomet, and the FDA. Tune in for a fun, in-the-weeds medical device discussion — I'll be there!

telehealth

Telehealth services reduced fatal drug overdoses

A study from CDC, CMS, and NIH researchers found that telehealth care offered to people with opioid addiction during the pandemic reduced the risk of fatal drug overdoses. Medications offered in an office setting also helped reduce the likelihood of a fatal overdose, researchers found. The study, published in JAMA, analyzed data among Medicare beneficiaries pre-pandemic and post-pandemic.

Mortality rates were higher generally in the post-pandemic group, but the percentage of deaths due to drug overdoses were similar between the two groups. The key finding: Medicare beneficiaries who received opioid addiction-related telehealth services during the pandemic had a 33% lower risk of a fatal overdose. Notably, only 1 in 5 beneficiaries used telehealth services, and only 1 in 8 received medication treatment.

health tech
Industry odds and ends

Consumer digital health company Transcarent has partnered with health care analytics platform CareJourney. CareJourney will offer the platform data on physician ratings and cost benchmarks.
Inato, a tech platform focused on clinical trial diversity, has raised $20 million in Series A funding. Investors include Cathay Innovation and Obvious Ventures.
Elucid, an AI imaging company targeting cardiovascular disease, hired Andrew Miller as its chief technology officer. Miller was previously CTO at chronic disease management company Engooden Health.
Robotic surgery company Virtual Incision has expanded its leadership team, appointing Piet Hinoul as chief medical officer. Hinoul was previously with oncology company Novocure.
Thierry Bernard, CEO of Dutch molecular testing company QIAGEN, has been named chairman of Advamed's diagnostic board of directors.

Also, a quick correction: in last week's edition, I wrote that GreyMatter Health's device treated PTSD with nerve stimulation. It actually uses self-neuromodulation.

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