September 24, 2020

Maverick's Update

Only What Matters On Health Information Policy

Maverick Health Policy is unsure how to connect Ruth Bader Ginsburg to health information policy, but we are sure that the existence and success of this former attorney, female-owned consulting firm is in no small part due to her tireless advocacy for women lawyers and all women who wanted, needed and deserved more than they were getting in the workplace. Thank you @NotoriousRBG.

• It could have been worse. We love this little mini-moment of positivity from Bryan Walsh of Axios Future, who pointed out that if the COVID-19 pandemic had come several years earlier, the “slower genetic sequencing technology would have made it much harder to identify and track the virus, and the idea that a vaccine could be ready within a year of the first case would have been impossible.”

• New ONC_HealthIT Webinar: September 24 at 4 pm ET to learn how to use the Security Risk Assessment Tool. Maybe it will help avoid a $1.5 million HIPAA fine for a security breach?

• Gladys and the PIP or MIPS? CMS published the similarities and differences between the Medicare Promoting Interoperability Program (“PIP” is for hospitals) and the Interoperability performance category of the Merit-Based Incentive Payment System (“MIPS” is for clinicians). PIP asks hospitals to report on at least 4 of 8 electronic clinical quality measures and MIPS asks clinicians to submit data on 1 of 4 performance categories. Both hospitals and clinicians must attest that they are not going to block health information from getting where it needs to go. For more information, view the Medicare Promoting Interoperability Program vs. MIPS Promoting Interoperability Performance Category Fact Sheet below:

PI Program vs

. MIPS PI Perf Category Inf

Download MIPS PI PERF CATEGORY INF • 727KB

One Thoughtful Paragraph

Just like high school students, we can all agree that science is hard. And even when you start to grasp a thing or two, it changes. That is why it is difficult to determine exactly what the FDA gets to regulate. Does it regulate lab tests? Sometimes. Are biologics regulated as a drug or a device (or both)? Yes. Does the FDA regulate medical software in medical devices? Well, the 21st Century Cures Act tried to make clear that the FDA does not oversee medical software by excluding certain software functions from the definition of “medical device” -- but the FDA still regulates so many of them that it has a whole section of its website devoted to “Examples of Device Software Functions the FDA Regulates” and another one that is called “Examples of Mobile Apps That Are Not Medical Devices.” For the past four years, the FDA has tried valiantly to clear up the confusion by creating a Digital Health Innovation Action Plan, issuing three guidance documents related to Digital Health, and launched a pre-certification program to allow trusted developers (i.e., specific companies) to pre-certify low-risk software that fall under the definition of medical devices. And now, this week, it launched the Digital Health Center of Excellence to modernize the FDA’s approach to regulating digital health technologies, like apps and wearables that are categorized as medical devices. [Need a job? They’re hiring!]. Only a truly excellent center will be able to keep up with the rapidly-changing digital health software trends, but the FDA already knew that science is hard.