Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention. As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased...more
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the...more
Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more
The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood alcohol levels. Users could simply plug the accessory into the headphone...more
This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more
The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers....more
How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more
The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new...more
On April 5, the Federal Trade Commission (“FTC”) announced that it had created a web-based tool designed to assist developers of health-related mobile apps identify and understand what federal laws and regulations might apply...more
As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more
Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more
It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more
While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more
Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of...more
Recently published studies are illustrating the types of issues that mobile health application, or “app,” developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape....more
Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more