May 20, 2022
Maverick's Update
Only What Matters In Health Information Policy
Did you miss us? We didn’t post anything last week because it was Friday the 13th and we didn’t want to tempt fate. But on this day in 1932, Amelia Earhart flew her famous solo flight across the Atlantic -- much better karma. Interestingly, almost exactly one year after Ms. Earhart’s daring flight, Walt Disney released its animated short film The Three Little Pigs, featuring the song Who’s Afraid of the Big Bad Wolf? We invite you to hum the tune while we describe who is singing that song now in the One Thoughtful Paragraph below.
Other news about who is building houses of straw or brick in the digital health world:
The FDA is ending the Digital Health Software Precertification Pilot (Pre-Cert) that provided alternative regulatory pathways for software as medical devices (SaMD) because further action would require Congressional action. This may be why the FDA official that helped develop the Pre-Cert program left the FDA to work at Google.
The CDC extended its deadline to May 27, 2022, for nominations to an advisory committee that will help with the implementation of the CDC's data modernization strategy, and the ONC published an update on who is going to be smart enough to help the public health sector with all those data modernization tools.
The ONC is making more moves to allow patients and industry stakeholders to get quick access to health information -- they released a number of procedures to help create health information networks and are preparing the third version of data standards to include lab results and social determinants of health. Meanwhile, the Health Innovation Alliance released a report on how the healthcare system can improve IT interoperability and data exchange.
One Thoughtful Paragraph
With a nod to Paul Keckley who can see a big bad wolf coming from a mile away, we agree that the confirmation of the tie-breaking vote on the Federal Trade Commission (FTC) is a big deal for healthcare stakeholders. The FTC is not only focusing on anticompetitive behavior in the healthcare sector -- but it plans to exercise its considerable jurisdiction over consumer data privacy protections, and that is squarely within the new commissioner’s area of expertise. As we said when he was first nominated, Alvaro Bedoya was the chief counsel of the U.S. Senate Judiciary Subcommittee on Privacy before he was the founding director of Georgetown Law’s Center on Privacy and Technology. And as HIPAA aficionados know, it is the FTC that protects consumers from unfair and deceptive business practices involving health data. That’s why on September 15, 2021, the FTC sent out a reminder that non-HIPAA-covered health apps must notify consumers if health data is released without authorization, or they will face penalties of up to $43,792 per day. But the FTC is just getting started. While there is noise about Congress making progress on a comprehensive federal privacy law, we will be watching the newly-empowered and activist FTC, which wasted no time getting started on its plan to blow houses down.