I wondered out-loud in a draft version of this blog post the following:
I cannot tell if this is the career politician FDA speaking or what, and frankly, this shouldn’t be an issue with any administration, but it sure is with this one.
Upon further review, this is the type of announcement was expected and favored; and consistent with the history of the FDA Commissioner, a political appointee of POTUS45. I fully understand the temptation to speed the process up of software when it comes to medical capabilities. This process has been thought carefully, but two things stand out for me.
- HIPAA is the law of the land when it comes to digital medical records. This is a complicated system; that is where we are. How does this idea of a pre certification tie into these requirements? Blog posts on this subject here, here, here, and here.
- All of this is moot if the majority of citizens can’t access it due to not being covered under Medicare and Medicaid; the very constituency that can be best served by digital medical options in software including telehealth initiatives.
As for point #2, the rules for current Medicare reimbursement are found here (PDF) and are in my opinion, lacking. A change of mindset when it comes to payment overshadows any other aspect of our current system. In my ideal health care system, there would be Medicare for all with the private insurance market to fill gaps similar to Medicare Supplement policies of today and to “jump the line” in services for a fee. Digital medical options, such as Telehealth and Software based Medical Case Management would be included in the base Medicare and Medicaid plans.