False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
This week, Heather and Lauren welcome Kimberlee Steele, the Managing Director for North America of SHL Medical, a world leader in the design, development, and manufacture of autoinjectors, pen injectors, and drug delivery...more
Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more
Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,...more
In November, McDermott Will & Emery was pleased to host our annual European Health & Life Sciences Symposium in Paris. Welcoming a large crowd of healthcare professionals, investors and dealmakers for a programme of...more
Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more
After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more
HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more
The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more
On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more
Although healthcare M&A activity in Q3 declined slightly from the previous quarter, analysts believe the activity level declined much less than expected given the numerous headwinds—inflation, rising interest rates, labor...more
Hosts Matthew Roberts, Darra Coleman, and Tina Emerson sit down together for a compelling conversation about health care hot topics currently impacting the industry. They discuss everything from behavioral health issues and...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
Join us in person on Miami Beach for exclusive networking and to hear from leading investors helping shape the future of healthcare private equity. The annual HPE Miami event features a world-class faculty, offers creative...more
At the end of Q3, aggregate funding raised by digital health startups in 2021 surpassed $20 billion. Although 2021 continues to be a record-breaking year for digital health startups, investors gently tapped the breaks in Q3....more
Following a record-breaking first quarter, merger and acquisition (M&A) activity within the healthcare industry kept pace during the second quarter of 2021, showing no signs of slowing. Although the volume of deal activity...more
For the fifth consecutive year, the Bass, Berry & Sims Healthcare Private Equity Team hosted BBS Connect, a forum to connect healthcare dealmakers during the annual J.P. Morgan Healthcare Conference. Over three days –...more
2020 was a tumultuous year for the healthcare industry, which continues to confront the effects of the COVID-19 pandemic. Despite these unprecedented and unpredictable times, healthcare merger and acquisition (M&A) activity...more