C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Tag Archives: FDA

FDA’s Medical Device Safety Action Plan

Posted in Digital Health, FDA, Health IT
On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request… Continue Reading

FDA Advances Flexibility-Based Framework for Digital Health and AI

Posted in FDA, Health IT, Medicaid, Medicare
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation. During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and… Continue Reading

FDA Issues New Guidance for Clinical and Patient Decision Support Software

Posted in Digital Health, EHR, Health IT
This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers.… Continue Reading

FDA Finalizes Guidance on Low Risk “General Wellness Products”

Posted in Health IT
In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides… Continue Reading

DOL, HHS & Treasury Issue Guidance on Contraceptives and Other Preventive Services under ACA

Posted in Employee Benefits, ERISA, Health Care Reform & ACA
On May 11, the Departments of Health and Human Services (HHS), Labor (DOL) and Treasury (collectively, the “Departments”) issued Part XXVI of their FAQs about Affordable Care Act implementation. This latest FAQ provides additional guidance regarding “first-dollar” coverage of preventive services under the ACA (i.e., the requirement to provide certain preventive services without the imposition… Continue Reading