News & Articles

Right-to-Repair – 2021: Legislate, Regulate, Litigate, or Collaborate?

G. Wayne Moore
02/09/2021

There are four paths forward currently being pursued regarding the so-called “Right-to-Repair” issue specific to medical devices; regulation, litigation, legislation, and collaboration. The FDA- initiated 3rd Party Service Docket central to this issue began almost 5 years ago. So, what has happened since March of 2016?

  • The FDA committed to draft a new guidance document regarding how to differentiate between remanufacturing and servicing. The draft was slated to be released in Q3 of 2020 and has still not been released. The FDA also initiated a Collaborative Community (CC) comprised of various stakeholders involved in the 3rd Party Service Docket to find a way forward to resolving the issues between the stakeholders. Since its initiation, both the FDA and the OEMs have subsequently withdrawn from the CC with no substantive progress having been made between the stakeholders. As it stands right now in Feb 2021, nothing has been accomplished through regulation.
  • However, not all has been silent on this issue as litigation over the last two years has been on the rise between OEMs and 3rd Party servicers, mainly centering around alleged violations of the Digital Millennium Copyright Act (DMCA) of 1998 and “hacking” into protected software safeguards. In addition to the millions of dollars being spent in legal fees, at least one well- known, after-market system provider has closed its operations and exited the market. Litigation is a two-edged sword: first, the specific issues being litigated often provide clarity relative to the enforceability of a given law; and secondly as in Charles Dickens’ novel “Bleak House,” everyone loses except the lawyers. There are four on-going suits that I am closely following as their respective outcomes will directly impact the 3rd Party Service question. The counterclaims (defendants) in these lawsuits seem to focus on violations of certain provisions of the Sherman Anti-trust Act and the enforceability of certain Copyright laws.
  • Interesting that there appears to be a clear bifurcation in the legislative strategy arena with OEMs pressing Congress to pass laws that will compel the FDA to act on its regulatory authority; and the Right-to-Repair (R2R) coalition is pivoting to the Federal Trade Commission (FTC) to act on their regulatory authority regarding what they believe are anti-trust issues. Both the OEMs and the R2R groups are also slugging it out at the State legislative levels across the country.
  • As mentioned earlier, collaboration between the two main stakeholders, OEMs and ISOs, does not appear to be headed anywhere until the FDA re-engages with the CC and takes the leadership role. There are simply too many contentious issues to do this in any other way. All the CCs that I am familiar with share common goals. For example, the AI CC works on the definition of terms, privacy issues, machine learning bias, etc. In my view, the 3rd Party Service issue involves radically different business models. One can argue, and it has been, that one common goal is patient safety. Although true, this issue has been turned into more of a weapon than a goal.

So, here we are in 2021, not much done, with a ton of money and time spent since March of 2016 with nothing to show for it. Am I hopeful for 2021? I believe that the FDA will release the Draft document sometime this year and it will be helpful, but not a cure all.

If there is any subject you would like me to weigh-in on in future articles please email me – gwmoore@acertaralabs.com, I would enjoy hearing from you.

Until Next Month,

Wayne

February 8, 2021 Newsletter