The Privacy Insider Podcast Episode 19: Where Tabletop Games Meet the Future of Privacy with Dr. Tehilla Shwartz Altschuler of the Israel Democracy Institute
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
Getting Personal—Wearable Devices, Data, and Compliance
I-24 – Thankful for Volume 1, 2017, and Relationships
The Intersection of Wearable Technology and the Insurance Industry
The Increasing Visibility of Driver Health
The Ever-Expanding Scope of Social Media Discovery
Wearables and the Future of Intellectual Property Law
What is Graphene? Fenwick Patent Attorney Has the Answer
AI-enabled smart glasses – which combine eyewear with real-time audio, video, and AI functionality – are now entering the workplace. They provide productivity and accessibility benefits by allowing users to capture...more
With the Milano Cortina 2026 Olympic Winter Games at center stage, Milan is well placed to highlight a fashion innovation that is already accelerating in the city: technical textiles and smart textiles that deliver...more
While the world has turned its attention to the Milan-Cortina 2026 Winter Olympics, spectators have been watching more than athletic excellence. The Games have also been a live showcase of patented sports technology. From...more
With the growing popularity of smart glasses and other wearable technology, we have heard a growing number of questions from clients concerned about employees’ use of these devices at work. ...more
On February 11, 2026, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) held a Town Hall to address industry questions and provide further clarity on the January 6, 2026, update...more
On January 6, 2026, the Food and Drug Administration (FDA) issued its General Wellness: Policy for Low Risk Devices guidance (the General Wellness Guidance), signaling that it does not intend to enforce traditional medical...more
Most elite winter athletes have heard a familiar refrain from their coaches: “Train how you want to compete.” But as we approach the 2026 Olympic Winter Games in Milano Cortina, that motto is evolving. Today’s athletes aren’t...more
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision support (“CDS”) software and general wellness products provide clearer, more...more
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates provide important clarification on how certain products may fall within, or outside, FDA oversight....more
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness Policy for Low Risk Devices...more
On January 8, 2026, the Ninth Circuit affirmed the decision of the U.S. District Court for the Northern District of California to grant Apple summary judgment against claims that it monopolized the market for heart rate...more
As we have discussed in prior posts, AI-enabled smart glasses are rapidly evolving from niche wearables into powerful tools with broad workplace appeal — but their innovative capabilities bring equally significant legal and...more
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
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
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
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
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
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
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
Tuesday, January 6, 2026, yielded two surprising updates from the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health....more
As we explored in Part 1 of this series, AI-enabled smart glasses are rapidly evolving from niche wearables into powerful tools with broad workplace appeal — but their innovative capabilities bring equally significant legal...more
On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS)...more
On December 1, the Centers for Medicare & Medicaid Services (CMS) announced the Advancing Chronic Care with Effective, Scalable Solutions Model (ACCESS), a 10-year voluntary alternative payment model (APM) that will pay...more
CMS announced plans to launch the ACCESS Model, a new payment model that tests an outcome-aligned payment approach in Original Medicare with an aim to expand access to new technology-supported healthcare options that help...more