Antitrust Considerations in Long-Term Care — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
The CMS Interoperability and Prior Authorization Rules
Hospice Insights Podcast: What’s the Latest on UPICs? Highlights from Recent Audit Activity, Part I
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
Hospice Insights Podcast - Stories of Successful Hospice Leadership: The CEO and Chief Medical Officer Relationship
Understanding Trends and Challenges in the Behavioral Health Sector
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 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
AGG Talks: Healthcare Insights Podcast - Episode 6: Charting the Future of Nursing Home Staffing
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
Healthcare Document Retention
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
Hospice Insights Podcast - A Rise in Medicare Deactivations: Tips for Avoiding This Financial Pain
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
Preventative Medicine: Health Care AI Privacy and Cybersecurity — The Good Bot Podcast
A recent decision by a California appellate court in Practice Fusion, Inc. v. Freedom Specialty Insurance Company, denying the policyholder more than $118 million in Directors & Officers liability coverage based on an...more
Google and Microsoft are spearheading the Coalition for Secure AI, focusing on supply chain security and mitigation strategies. Whether this attempt at self-regulation will ultimately succeed is unknown, as it overlaps with...more
Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more
In the privacy world, pixels, cookies, and tracking technologies get all the attention these days. Plaintiffs and regulators alike have been working to persuade courts nationwide that the presence of third-party tracking...more
On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers...more
HIPAA applies to both covered entities (e.g., healthcare providers and health plans) and their business associates. A “business associate” is generally a person or entity that “creates, receives, maintains or transmits”...more
Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...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, we take an in-depth look at generative artificial intelligence...more
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more
Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
Brightree by ResMed (“Brightree”), a cloud-based management software platform for healthcare providers, has conducted its biannual interoperability survey, and issued its corresponding biannual Interoperability and Engagement...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
The Israeli Privacy Protection Authority (PPA) recently published a document for public comments entitled, “Protecting Patients’ Privacy When Transferring Medical Information via Digital Devices and Undesignated Software.”...more
On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the...more
On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more
On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more
On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”)...more
On March 20, 2020, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a new guidance document for industry and FDA staff, attempting to “help expand the availability and capability...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more