Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
Podcast - Regulating AI in Healthcare: The Road Ahead
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 244: The Future of Independent Physician Practices with Ray Waldrup of The Leaders Rheum
Empowerment Through Hero Generation with Nicole a`Beckett and Dr. Shruti Roy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
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
Hospice Insights Podcast - But Wait: Things to Consider Before Adopting AI Tools In Your Hospice
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Health + Tech - Leveraging AI to Drive Growth
Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 157: Sarah Glover, Maynard Nexsen Cybersecurity Attorney
Podcast - Insights on the FTC's Approach to Digital Health Companies
Over the past several years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to recognize and pay for non-face-to-face services that improve care management...more
Comments on the RFI, due by June 16, present a rare opportunity to shape future technology standards, reporting requirements, and business opportunities....more
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more
The Federal Trade Commission (FTC), at its May 18, 2023, open Commission meeting, voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment...more
On May 18, the Federal Trade Commission (FTC) proposed changes to the Health Breach Notification Rule (the HBNR or the Rule), including clarifying the rule’s applicability to health apps and other similar technologies. These...more
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more
The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
Key Wireless Deadlines- NIST Requests Comment on Staging Cybersecurity Risks for Enterprise Risk Management and Governance Oversight: The National Institute of Standards and Technology (NIST) seeks comment on Draft NISTIR...more
n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...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
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
The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more
Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more