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Digital Health

Bass, Berry & Sims PLC

Red Light / Green Light: Navigating the Traffic Signals from the 44th Annual J.P. Morgan Healthcare Conference

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As we rang in the new year and gathered in San Francisco for the 44th Annual J.P. Morgan Healthcare Conference, one theme consistently emerged: healthcare investing remains a market defined by contradiction....more

Latham & Watkins LLP

FDA Issues Updated Guidance Loosening Regulatory Approach to Certain Digital Health Tools

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The updated guidance expands the scope of digital health tools, including certain types of wearables or clinical decision support software, that are legally exempt or otherwise free from FDA medical device oversight....more

Sheppard Mullin Richter & Hampton LLP

“Deregulation” on the Menu: Big Changes for Wellness and CDS Technologies

Last week, the U.S. Food and Drug Administration (“FDA”) rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final...more

Sheppard Mullin Richter & Hampton LLP

Day 3 Notes from the 44th Annual J.P. Morgan Healthcare Conference

I have to admit to an instinctive gut reaction of skepticism when Kimberly Powell of NVIDIA on Monday said that “AI is a once-in-a-lifetime shift for the healthcare industry.” Intellectually, I am excited by AI and its...more

Loeb & Loeb LLP

FDA Updates Its "General Wellness" Device Framework—What Companies Need to Know

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Since 2019, companies that offer software and/or hardware devices aimed at promoting consumer health and wellness have had little more to rely on than a single short U.S. Food and Drug Administration (FDA) guidance document...more

Loeb & Loeb LLP

AI Outlook 2026: Celebrating Client Innovation and Exploring Future Trends

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Artificial intelligence (AI) offers extraordinary opportunities but also complex challenges as it reshapes industries and redefines how businesses operate across sectors. ...more

Ropes & Gray LLP

DOJ’s Done Global Telehealth Prosecution Signals Expanded Criminal Risk for Telehealth Platforms, MSOs, and Investors

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Amid increasing investor interest in the telehealth sector, a recent Department of Justice (“DOJ”) prosecution involving Done Global underscores evolving enforcement risks for telehealth platforms, management services...more

ArentFox Schiff

FDA Issues Updated Guidance on Low-Risk General Wellness Devices and Clinical Decision Support Software

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On January 6, the US Food and Drug Administration (FDA) released two significant updates potentially important for companies operating in the consumer health technology space....more

Foley & Lardner LLP

Protecting the AI Advantage: Why Patents Are a Critical Growth and Risk-Management Tool for Digital Health Platforms

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For CEOs, general counsels, and CTOs, the question is no longer whether patents matter. The question is whether the company has an intentional strategy to identify, capture, and deploy intellectual property in alignment with...more

Moritt Hock & Hamroff LLP

Telehealth Plays A Growing Role In Tackling New York’s Mental Health Crisis

In the wake of the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) made permanent several major expansions to telehealth coverage under Medicare by broadening the list of services that could be...more

Blank Rome LLP

FDA Loosens the Reins on Wearable Tech

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FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its policy on general...more

Sheppard Mullin Richter & Hampton LLP

Day 2 Notes from the 44th Annual J.P. Morgan Healthcare Conference

J.P. Morgan continues to surprise us at lunch, with the Mayor of San Francisco sharing on Monday an update on recent improvements in the city. Then on Tuesday at the Grand Ballroom lunch, it was the first episode of my...more

Sheppard Mullin Richter & Hampton LLP

Notes from Day 1 of the 44th Annual J.P. Morgan Healthcare Conference

At the 44th Annual J.P. Morgan Healthcare Conference, Jamie Dimon (CEO of J.P. Morgan) told the audience that we should be teaching healthcare in school from kindergarten to 12th grade. He was right…but we don’t. And,...more

Ankura

Navigating China’s Health Transformation: Opportunities and Challenges for Multinationals

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The intensity of China’s transformation over the past decades has unleashed unparalleled momentum while also presenting profound challenges to its socioeconomic ambitions, impacting how multinationals navigate this new...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: AI and the FDA

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the twelfth episode of When Your Life Sciences Are on...more

Haynes Boone

The FDA Opens a Wider Door for Wellness Wearables

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As Americans kick off the new year with resolutions to get fit, sleep better, and take better care of themselves, the FDA has broadened access to the wearable wellness device market to a greater number of products. In a...more

Quarles & Brady LLP

Utah Authorizes AI-Based Prescription Renewals

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Utah has issued a policy, through the Utah Department of Commerce and its Office of Artificial Intelligence Policy, authorizing a pilot program that allows an artificial intelligence (AI) system to autonomously renew certain...more

McDermott Will & Schulte

FDA loosens the reins: New AI and wearables guidance

On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off approach to digital health product regulation. Both updated guidance...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions: Year in Review

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At the end of 2024, we predicted that the healthcare mergers and acquisitions (M&A) market would pick up steam in 2025 given the combination of decreasing interest rates, a potential shift in the regulatory landscape with the...more

McGuireWoods LLP

Signaling More Flexibility, FDA Says More Wearable Devices Qualify for General Wellness Exception

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The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a more flexible regulatory...more

Orrick, Herrington & Sutcliffe LLP

FDA Eases Oversight for AI-Enabled Clinical Decision Support Software and Wearables

FDA Commissioner Marty Makary announced policy shifts that ease the path to market for certain digital health technologies, including AI- and generative AI-enabled clinical decision support software (CDS) and consumer...more

King & Spalding

FDA Updates General Wellness and Clinical Decision Support Guidance Documents

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On January 6, 2026, the Food and Drug Administration (FDA) published revised, final versions of its guidance documents on general wellness products and clinical decision support (CDS) software, superseding the prior versions...more

McDermott Will & Schulte

May 2026 deadline: HHS imposes accessibility standards for healthcare company websites, mobile apps, kiosks

A US Department of Health and Human Services (HHS) Section 504 final rule imposes a May 2026 deadline on covered healthcare companies. Never before has a rule required all recipients of federal financial assistance –...more

Hogan Lovells

JPM 2026: AI compliance and BIOSECURE top list of device supply chain concerns

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As life sciences companies expand internationally, regulatory readiness must evolve into a strategic capability that supports global business planning and innovation....more

Polsinelli

Ringing in the New Year with Digital Health: FDA Updates Guidance Documents on Clinical Decision Support Software and General...

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Key Takeaways: FDA updated two key digital health guidance documents to align with the Administration’s emphasis on deregulation and innovation in health care technology, including the use of generative AI....more

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