AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Health + Tech - Leveraging AI to Drive Growth
Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 157: Sarah Glover, Maynard Nexsen Cybersecurity Attorney
Podcast - Insights on the FTC's Approach to Digital Health Companies
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Podcast - SEC's Oversight on Cybersecurity Requirements
Podcast - Digital Health Market Assessment
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Video: Leaders Moving Business Forward Featuring Clear Eye Test
Guidepost in Motion: Vori Health Launching a Virtual Healthcare Start-Up from a Compliance Perspective
Leaders Moving Business Forward with Naveen Kathuria of eFamilyCare
Health+Tech - Episode 3: Leveraging Technology to Improve Physician Contracting
Health+Tech - Episode 2: Edge of Digital Health Transformation
Healthcare Headlines Episode 1 - Telehealth: Future Trends & Industry Impact
Healthcare Tech: How Are Licensing Agreements Bridging the Industry Divide?
It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At...more
New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more
What You Need to Know in a Minute or Less - The use of pixel technologies on websites and mobile apps in the health care field has garnered considerable attention from regulators and the plaintiffs’ class action bar....more
Summary - On May 18, 2023, the Federal Trade Commission (“FTC”) announced a Notice of Proposed Rulemaking (the “Proposed Rule”), which both clarifies the scope of the Health Breach Notification Rule (“HBN Rule”) to include...more
The Federal Trade Commission (FTC), at its May 18, 2023, open Commission meeting, voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment...more
Report on Patient Privacy Volume 23, no 2 (February 2023) DCH Health Systems, based in Tuscaloosa, Ala., said it fired an employee in December after a routine privacy audit revealed evidence that the worker had accessed some...more
For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more
The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...more
California Attorney General Rob Bonta has issued statement about protecting health data in mobile apps in view of the upcoming SCOTUS decision in Dobbs. In the process, he also signaled continued enforcement....more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more
The regulatory scrutiny on telemedicine and digital health companies continues to tighten, whether it is privacy warning shots, new direct-to-consumer (DTC) advertising limits, a wave of reimbursement audits, or multistate...more
Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While...more
A key tech initiative as COVID-19 vaccinations begin rolling out are digital health passports. One example is being developed by a group of large tech companies along with the Mayo Clinic as part of the Vaccination Credential...more
The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps)....more
Consumer-directed health apps are experiencing a boom thanks to COVID-19, as consumers seeking to avoid doctors’ office waiting rooms are increasingly relying on apps to measure and maintain their health. That trend is...more
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more
Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC. This year, Health Datapalooza was co-located with the National Health Policy Conference, providing attendees with an...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
Last month, the Food & Drug Administration (FDA) issued a long-awaited revision to its Policy for Device Software Functions and Mobile Medical Applications Medical App - Guidance for Industry and Food and Drug Administration...more
Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more
On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more
A recent issue of MIT’s Technology Review magazine is titled, “Look how far precision medicine has come.“ At least part of the premise is that personalized medicine or precision medicine is not perceived as having made the...more
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more