Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences with Jennifer McEwen of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation with Dr. Ecoee Rooney of Indicator Sciences
Unexpected Paths to IP Law with Dan Young and Colin White
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
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 | Episode 232: Commercial Real Estate for Life Sciences Companies with Vinnie Durand of Savills
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry with Arda Ural of EY
Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
This week, Heather and Lauren welcome back their colleague Brandon Robinson, head of Maynard Nexsen’s Data Privacy and Cybersecurity team. Following up on our discussion of data privacy risks for health care providers on...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more
For episode 211, Heather and Lauren are joined by their colleague Brandon Robinson, who heads up Maynard Nexsen’s Data Privacy and Cybersecurity team. Brandon shares his wealth of knowledge on cybersecurity best practices for...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Brent Hoard and Andrea...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
Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more
Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more
Maynard Nexsen cybersecurity attorney Sarah Glover joins hosts Heather and Lauren to discuss cyber attacks on health care organizations. Sarah shares her perspective on risk factors, how to mitigate risk, and the cost of data...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
Los prestadores de asistencia sanitaria almacenan y utilizan historias clínicas electrónicas ("HCE") en el contexto de la prestación de dichos servicios sanitarios. Sin embargo, la configuración de dichas HCE por parte de los...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more
Hosts Matthew Roberts and Amanda Loveday welcome their colleague Joe Dickinson, a Nexsen Pruet Cybersecurity attorney, for episode 114. Joe discusses how matters of data governance, privacy, and cybersecurity are increasing...more
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells attorneys Dan Whitehead, Bonella Ramsay, Louise Crawford, and Imogen Ireland convened with industry leaders virtually at the Health Care AI Law and Policy...more
Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...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
Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more
Although the COVID-19 pandemic exposed cybersecurity vulnerabilities across sectors, it has particularly challenged the resilience of information systems for health care and life sciences companies. Because ransomware attacks...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
With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
The healthcare and life sciences (HCLS) sector remained particularly active throughout 2020. Despite the COVID-19 pandemic, deal activity was very strong in the first half of the year — with notable transactions including...more
Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more