The enforcement date for the European Union (EU) Medical Device Regulation (EU 2017/745) (“MDR”) is quickly approaching. While the MDR entered into force on May 25, 2017, the three-year transition period ends on May 26, 2020. United States medical device manufacturers that do business in Europe must act fast to ensure compliance.[1] This blog provides […]
Whose Charge is it Anyway?: Changes to Fees for Medical Records Requests Under HIPAA
Changes are underway for the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Following a recent court ruling in Ciox Health, LLC v. Alex Azar, et al. (the “Ciox Case”) and a subsequent Department of Health and Human Services (HHS) notice, the Patient Rate fee limitation no longer applies when patients request the delivery of their […]
Tuning-Up: Music Licensing Considerations for Mobile Applications
Many mobile applications include background music, or play videos that include background music. Mobile application developers should be aware that even background, or “incidental,” music requires permission (a “license”) for use. This blog post details the procedure and costs necessary to legally use background music in mobile applications. I. What Requires a License? The United States […]
The Health Care Entrepreneur’s Quick Guide to Important Laws: Part 2
Health Care Entrepreneurs need to know about the False Claims Act, Qui Tam Provisions and HIPAA. At a recent event, “Health Law 101: Key Legal Issues for Health Care Companies,” speakers identified the top five legal and regulatory issues for health care entrepreneurs to be aware of: The Anti-Kickback Statute, Stark Law, False Claims Act, […]