November 5, 2021
Only What Matters On Health Information Policy
Life is not simple right now. Even our movies are complicated. Take the new movie Dune, for instance. It is based on a convoluted, brick-heavy sci-fi novel about a futuristic life where harvesting an all-important spice in an unforgiving desert planet is the basis for epic wars and a Christ-like leader. So, it's complicated. The good news is that the film actors are SO good-looking that it is worth powering through Hans Zimmer’s overly-dramatic musical score that substitutes for the lack of decent dialogue to peer into the (blue?) eyes of Zendaya and trying to peer at all of Jason Momoa (which may be why it is an IMAX movie). But it is not just our movies that are complicated. More examples of our not-so-simple lives in the One Thoughtful Paragraph.
This week’s news is not simple either:
The FDA released draft guidance for makers of medical device software (and software used as a medical device, which is different) so they know what to provide in premarket submissions to the agency to get their products evaluated for safety and effectiveness purposes.
The U.S. House Energy and Commerce Committee Republicans released the Control Our Data Act, a draft privacy bill to create a national privacy standard and a Bureau of Consumer Privacy and Data Security. The proposed legislation would not let private citizens sue about privacy violations or allow state privacy laws to govern beyond the new federal standard. What is interesting about this is that the House Democrats are trying to put something like the Republicans' Bureau of Consumer Privacy and Data Security idea into the big budget reconciliation bill, by expanding the FTC’s Division of Privacy and Identity Protection.
One Thoughtful Paragraph
Dune’s musical score by Hans Zimmer is so theatrical, that he may consider setting some of these federal policy mandate announcements to music too (Darth Vader’s walk-in music comes to mind, but John Williams has earned the right to stay retired). Our latest trumpets-blaring mandate came on November 4, when the U.S. Department of Labor’s Occupational Safety and Health Administration issued a new rule (helpful summary of the “emergency temporary standard” or "ETS" here) which says that all private-sector companies with 100 or more employees must get vaccinated or submit to weekly COVD-19 lab testing and masking-up at work. Our question, as data-focused policy people, is “if an employer chooses weekly lab testing, who is reporting the lab test results?” The ETS makes clear that at-home lab testing results may not be self-reported by employees, but “can be observed by employers without laboratory processing” and employers are expected to keep records. Is there an official process to report that data so we have a record of who is positive and who is negative? If the object of the game is to make certain COVID-19 is not spreading, what is the mechanism for alerting public health authorities if labs are not processing the test results? [insert Darth Vader music here].