Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 218: Artificial Intelligence in Drug Development with John Van Hoy of PPD & Thermo Fisher
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
The Evolving Landscape of Behavioral Health Transactions: Insights from Industry Professionals
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 211: Cybersecurity and Privacy Risks for the Healthcare Industry with Brandon Robinson of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark Moore and Michael Parente of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
The CMS Interoperability and Prior Authorization Rules
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more
On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill almost exactly one year ago. ...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Attacks on the life sciences and healthcare sectors (healthcare providers and health technology, medical device, pharmaceutical and biotechnology companies) increased significantly in the last year, including at the World...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
Blockchain—the tamper-proof electronic ledger network technology—first made headlines with the rise of cryptocurrencies like Bitcoin. Independent of that boom-and-bust cycle, the life sciences industry is now exploring ways...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more
As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more
Cybersecurity continues to be headline-grabbing news, particularly following recent reports of high-profile cyber attacks on a number of major well-known corporations. Conscious of their fiduciary duties, boardrooms of global...more