Healthcare & FDA Law Blog

We review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical reasons.

New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.

What mobile mental health app manufacturers and the physicians who recommend and use these apps need to understand about FDA regulation of medical devices.

What are mental health mobile apps? What are the benefits and some of the concerns, such as privacy, about manufacturing and recommending these apps.

Administrative and legal issues involved with the CMS’s Sunshine Rule including reviewing and disputing payments manufacturers of drug and medical device report to CMS.

The Sunshine Rule of the Affordable Care Act requires that drug and medical device manufacturers disclose to CMS any payments they made for the benefit of physicians regarding the drugs or devices.

Health and Human Service’s healthcare compliance guide for new physicians includes the billing requirements for submitting claims to federal programs and commercial insurers.

An interactive questionnaire for mobile health app and medical device developers that covers compliance issues for HIPAA, the FDA&C Act, and the FTC Act

Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial apps, and wellness apps.