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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.