C&M Health Law

C&M Health Law

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

Tag Archives: 21st Century Cures

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

Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

Posted in Health IT
On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the… 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

The AMA Takes a Position on Mobile Health Applications

Posted in Health IT
The AMA recently adopted a set of principles on mHealth applications (mHealth apps) and other similar digital health tools, to guide coverage and payment policies and the AMA’s advocacy efforts. While many have touted the potential health benefits of mHealth apps and digital devices, the AMA also raises concerns about the potential health and safety… Continue Reading