Alaap B. Shah, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “Don’t Worry, You (Probably) Won’t Have to Deal with ONC: Algorithm Transparency Rule May Have Surprise Effects on Medtech Firms,” by Hannah Daniel. (Read the full version – subscription required.)
Following is an excerpt:
The Office of the National Coordinator for Health Information Technology’s (ONC) rule on algorithm transparency and information blocking may not directly affect medtech companies, but they may be subject to third-party liability consequences.
The ONC recently finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule, and Alaap Shah, a health law expert and member of Epstein Becker Green, spoke to Medtech Insight about the uncertainties of the rule and how it could apply to medtech.
Notably, Shah doesn’t believe that this rule means medtech companies will be directly interacting with the ONC, an office that rarely crosses path with the industry.
He does see a scenario where the role could have a “second-order impact” on medical device companies.
For instance, if a software as a medical device (SAMD) company is looking to get its solution embedded into the clinical workflow of an electronic health record (EHR) company, then the HER company could have obligations under the ONC rule and would need to consult the medtech company about its product, he explained.
In that case, there will have to be conversations about risk allocation and who bears the burden of liabilities.
“There may also be obligations for the medtech company to also help the EHR company comply with whatever the ONC is asking them to do with respect to transparency,” Shah explained.
