Compliance Is Not a Checklist
How can healthcare organizations manage the black box that is a third-party AI solution in their environment? This is where an innovative approach to risk mitigation needs to happen. Organizations can’t think of compliance as merely a checklist to complete. In a list of 20 mandatory items, a single “no” can mean an organization isn’t compliant. Risk management frameworks are in the category of “-ish,” which means that organizations can be “compliant-ish,” or somewhat compliant. That is worlds better than complete noncompliance.
Still, whether an organization adopts a certain AI risk management framework comes down to the current culture for risk in its environment. Is it much more conservative? Does it have stricter requirements because of a previous data breach?
Vendors are given a lot of trust, especially because there isn’t a certification body that can offer a “badge” that a certain AI solution is set to handle a level of risk. This is a real challenge, because it’s unclear whether these solutions are fully vetted. It then becomes the responsibility of the healthcare organization to strengthen its risk mitigation strategy so that innovation can still flourish. It’s a tricky balance to find.
This is why it’s useful for healthcare organizations to share the knowledge and experiences they’ve had with certain solutions; but of course, it’s harder to share experiences that may not have been so positive.
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Organizations Need to Trust but Verify AI Solutions
When a mature organization wants to adopt new patient-facing devices, there’s commonly a lab or some sort of proving ground for a contained trial to monitor traffic and other aspects. For example, the technical teams will want to figure out how that device is communicating, because it will be in service in the environment for years, maybe decades, so there’s a thoughtful lifecycle management process behind it.
AI solutions should be treated the same way. Test out the ambient clinical documentation software in a controlled setting before wider deployment. Build governance structures that involve working closely with the partner or vendor. As a healthcare CISO, I would much rather go with product A, which fully discloses how it works but may not be top of the line, than product B, which may be the best solution technologically but doesn’t share anything about how it works. If I’m going to open my organization up to risk, I would rather have that working relationship with a partner who is willing to be more open about the product.

