Stakeholders not working together to develop AI standards, expert laments

Cincinnati, OH – Collective intelligence is necessary for the creation of standards for artificial intelligence.

That was the message Pat Baird, senior regulatory specialist at Philips brought to the AI Summit held by the AFDO/RAPS Healthcare Products Collaborative.

Baird noted that several organizations are developing AI/ML standards, including ISO/IEC JTC 1/SC 42, a joint committee of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). While the standards the group is developing are unlikely to be used for medical devices, they may be helpful to medtech stakeholders on how to implement medical device standards, he said.

Baird also pointed to ISO’s TC 215, a technical committee on health informatics and communications, which has created a task force to help medtech manufacturers develop new standards and collect use cases. He noted organizations such as the Institute of Electrical and Electronics Engineers Standards Association (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), British Standards Institution (BSI), and Consumer Technology Association (CTA) are all working on AI standards, and some of them are working on healthcare-specific AI standards.

Despite the large number of stakeholders and organizations working on AI standards, Baird begrudged that they weren’t working more collaboratively, which is slowing down progress.

“Lots of people are interested in this, there are lots of different groups that are developing stuff, and almost no one is talking to each other,” he said.

Baird recalled being in a meeting about medical device interoperability standards with other experts, where he concluded that there were significant communication barriers creating hurdles hindering progress.

“I realized that before we can get machines to talk to each other, we need to be better at getting the people to talk to each other, so I repeat that same thing here,” he added. “We need the collective intelligence to support the artificial intelligence.”

Baird has been especially active over the past several years, conducting literature searches and developing a list of standards, especially around cybersecurity, that medtech manufacturers can use on their connected devices. However, he noted that adopting such standards has been a very slow process.

Early recognition of consensus reports – essentially first drafts of standards – may be the way to go, Baird said in an interview with Focus. He noted that the US Food and Drug Administration (FDA) approached AAMI a few years ago to help develop a consensus report on AI/ML products meeting requirements for medical devices because developing standards and technical information reports (TIR) was taking too long.

As a result, AAMI’s CR34971 became the first FDA-recognized consensus report before it was recognized as a TIR earlier this year.

CTA also has been developing standards on AI/ML medtech-related products extremely quickly because they meet every few weeks rather than every few months like some other standards organizations, Baird noted, adding that part of the problem is that people who develop standards are typically volunteers in the industry who must focus on their day job.

“CTA is great because they move so fast, but one of the challenges of CTA is that they're US-only for at least medical device stuff, so a lot of people don't know they exist, but damn, they move fast,” said Baird. “I really wish CTA was international.”

Stakeholders not working together to develop AI standards, expert laments

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