Healthcare & FDA Law Blog
Medical Image Analysis Software – Part One
New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.
What are Mobile Mental Health Apps and How Are the Apps Regulated? Part Two
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 Mobile Health Apps and How Are These Apps Regulated? Part One
What are mental health mobile apps? What are the benefits and some of the concerns, such as privacy, about manufacturing and recommending these apps.
What Are the Main Issues Involved with The Implementation of the Physician Payments Sunshine Act?
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.
Drug and Medical Device Manufacturers Need to Comply with the ACA’s Sunshine Act – Part One
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.
A Healthcare Compliance Guide for New Physicians – Part One – Physician Relationships with Payers
Health and Human Service’s healthcare compliance guide for new physicians includes the billing requirements for submitting claims to federal programs and commercial insurers.
Compliance Laws for Mobile Health Apps
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
Digital Health and FDA – Part Two
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.
Digital Health and FDA – Part One
The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and telemedicine.
Contact Us
