US senators seek heightened scrutiny around AI’s use in healthcare
Meanwhile Finance Committee Ranking Member Mike Crapo, R-Idaho, touted the need for “responsible and ethical” AI deployment, with appropriate safeguards for privacy and security. In cases such as algorithms, applied by insurers to expedite utilization management, “improper denials or delays of needed services warrant government scrutiny.” But in other instances, including AI-related challenges stemming from insufficient provider experience and education, a lighter legislative touch is needed.
“Along these lines, AI highlights the need for adaptability,” Crapo said in his remarks. “One-size-fits-all, overly rigid, and unduly bureaucratic laws and regulations risk stifling life-saving advances and becoming outdated before they are even codified.”
Peter Shen, head of digital health, North America, at Siemens Healthineers also testified during the hearing. He highlighted work that is already underway to improve transparency around imaging AI. Shen cited the American College of Radiology’s new program, which asks AI manufacturers to disclose details about how they created algorithms. Its aim is to aid radiology practices in selecting products tailored to their needs.
Siemens Healthineers was among the first eight vendors to sign up for the initiative, Shen noted. He said the company has sought to build algorithms that are accurate and unbiased, using training data from individuals of different ages, genders, ethnicities and healthcare profiles.
Shen believes concerns around AI bias are currently addressed under existing risk management processes, quality systems, and compliance with requirements from the FDA and other regulators.
“With the rapid acceleration in development and innovation of AI, the need for the regulatory environment to be able to balance safety, effectiveness, as well as update and improve functionality, without hampering innovation and adoption, is critical,” Shen said in his testimony. “While we believe the current regulatory framework is sufficient to support AI innovation, we support the continuation of flexibility in the approval process, as a one-size-fits-all approach could seriously inhibit the potential of AI, as well as efforts to facilitate global harmonization and the development of appropriate international consensus standards.”
You can watch a recording of the hearing, and read testimony from other witnesses, here.