Tag Archives: FDA

Five Ways the SCOTUS Decision on ACA Will Affect mHealth

Posted on June 28, 2024 by

The upholding of the majority and key points of the ACA by the Supreme Court was a monumental step in changing healthcare in the USA. It is reform. It is not the creative destruction that is necessary in … Continue reading →

Posted in FDA, health insurance, healthcare economics, Healthcare IT, healthcare reform, informatics, medical apps, mHealth, mobile health, politics, technology, wireless health | Tagged , , , , , , , , , | 3 Comments

Medical Device Recalls: Implications for Digital Health Technologies

Posted on April 12, 2024 by

Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication. A recall of those types of products often implies taking them off the market as … Continue reading →

Posted in digital health, FDA, healthcare reform, Implantable Defibrillators, medical devices, mobile health, technology, wireless health | Tagged , , , , , , , , | 5 Comments

Crowdsource-derived Data for Post-Market Surveillance of Drugs and Medical Devices

Posted on April 5, 2024 by

Recently,Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. It requires the FDA to issue a Unique Device Identifier rule by the end … Continue reading →

Posted in clinical trials, digital health, FDA, mobile health, wireless health | Tagged , , , , , , , | 1 Comment