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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
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 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
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 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 198: Artificial Intelligence in Healthcare and Life Sciences with hosts Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
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
MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more
Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more
Revisiting…Are Automakers Making Sufficient Efforts to Protect Customer Data? As a follow-up to our previous article and webinar, “Are Automakers Making Sufficient Efforts to Protect Customer Data?", we are addressing the...more
Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more
AI-Created Art isn’t Copyrightable, Judge Says in Ruling that Could Give Hollywood Studios Pause - “A federal judge upheld a finding from the U.S. Copyright Office that a piece of art created by AI is not open to...more
This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
This is Part Nine in a series of legal updates on the Washington My Health My Data (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
This is Part Seven in a series of legal updates on the Washington My Health My Data (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more
Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more
The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more
On 13 June 2022, the Department of Health and Social Care released its new Strategy for the use of health and social care data in the UK (Data saves lives: reshaping health and social care with data), which should be read in...more
Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more
In mid-January 2021, the European Data Protection Board (EDPB) announced by press release that it has adopted jointly with the European Data Protection Supervisor (EDPS) written Opinions on the European Commission’s drafts...more
Key Takeaways - A new draft EU Regulation aims to encourage the sharing and re-use of data and foster a data-driven economy that shares the benefits of Big Data whilst respecting individuals’ rights in personal data and...more
With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Services has released guidance that provides a set of good practice principles for third-party partners to follow....more
On January 1, 2020 California Consumer Privacy Act (“CCPA”) largely came into effect, albeit with several last-minute modifications and a need to promulgate regulations. ...more
The COVID-19 pandemic has generated a renewed focus on biotechnology and life sciences companies. Non-U.S. investors need to be aware of the potential that the Committee on Foreign Investment in the United States (CFIUS) may...more
The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
The Situation: The Committee on Foreign Investment in the United States ("CFIUS," or the "Committee") recently published draft regulations implementing the Foreign Investment Risk Review Modernization Act ("FIRRMA"), which...more
The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more
On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges and opportunities in two of the sector’s...more