The CMS Interoperability and Prior Authorization Rules
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
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
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
On March 13, 2024, Utah Governor Spencer Cox signed Utah State S.B. 149, the Artificial Intelligence Policy Act (the AI Act) into law, which amends the Utah consumer protection and privacy laws to require disclosure, in...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more
Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system....more
A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) - Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more
On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an...more
Mrs. Skounakis died of a coronary artery occlusion after being prescribed an unusual combination of drugs (phendimetrazine and liothyronine) by Dr. Sotillo for weight loss. Her husband sued Dr. Sotillo for malpractice. What...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more