Karen Mandelbaum, Senior Counsel at Epstein Becker Green P.C., explains why healthcare leaders need to build a coalition of multiple experts on AI regulatory governance in the AI adoption process.
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Understanding the Impact of Healthcare AI Regulations and Guidelines
Having worked in healthcare technology for over 20 years, I’ve witnessed many efforts of healthcare tech languish and die on the vine. Many great ideas that could have had a massive impact can be found in the medtech graveyard. So it begs the question: how is healthcare AI any different?
If we take stock of exactly where we are right now, we can see we’re at a “climatic moment” of the healthcare AI movie. We have a perfect storm of rapid adoption and implementation alongside government mandates for data codification and interoperability. This moment is the culmination of over 30 years of work by experts in healthcare, technology and regulation to drive adoption, usability and utilization. Perhaps serendipitously, this all coincides with a massive increase in the data that healthcare teams are struggling to work with, further priming the field to reap the many benefits AI can offer.
But for now, let’s consider a series of questions that have been buzzing in my (and others) mind: with the influx of worldwide regulatory bodies and physician groups coming out with regulations and guidelines on implementation and effective use of AI in healthcare facilities, what is the common throughline? With the 1,200+ pages (and counting) of regulatory material to parse, what are some of the biggest takeaways? What is the impact that we anticipate now and moving forward?
Why Now? The Maturation and Regulation of AI
As outlined above, the rapid adoption and implementation of healthcare AI necessitates governance. Further answers to the question of “Why now?” include:
- AI governance is evolving to meet the growing needs to prevent misuse and ensure patient safety as AI is increasingly deployed across diverse health settings.
- Recent legislative and guideline developments provide guardrails for innovation, striking a balance between fostering rapid progress and maintaining patient-centered ethics.
Becoming a Standard of Care
Supporting the idea that AI is on the path to becoming a necessity in clinical practice, the advent of new regulations and guidelines concede some nontrivial realities:
- These guidelines and regulations mark a maturation phase, signaling that clinical AI is on the path to becoming the standard of care.
- The oversight and frameworks offered by these measures guide users through all phases of AI: from vendor selection to adoption and deployment.
Impact on Hospital Leaders
Amongst the most pressing questions is how this all impacts hospital leaders in need of effective solutions in clinical workflows. The answer depends on where you are in the AI journey:
- For those starting their AI journey, these guidelines and regulations simplify vendor evaluation, promoting utility and maturity assessment.
- Existing AI users gain impetus and tools to scrutinize their vendors, empowering them to foster a thoughtful approach to renewals and ensuring continued adherence to ever evolving standards.
Impact on Patients
Implementing new tech into a health system is no small feat. At the end of the day, the aim is to positively impact the patient experience. Here are a few ways in which recent guidelines and regulations impact patients:
- Rigorous vendor scrutiny aims to promote appropriate AI utilization, resulting in improved patient outcomes.
- Broader adoption and consistent use across healthcare systems will offer opportunities to enhance the impact of AI on patient care.
Commonalities Across Guidelines and Regulations
Regulatory bodies and medical boards aren’t creating these rules and suggestions just for the sake of it. There are important throughlines to consider, especially:
- Common language, unique approaches and key areas such as oversight, transparency, privacy and security considerations unite these guidelines.
- A consistent focus on risk management underscores the industry’s commitment to responsible AI development.
The recent surge in AI legislation and guidelines reflects a crucial turning point for healthcare. As AI matures into an accepted standard of care, these pieces will provide the necessary structure for responsible development and deployment. For health system leaders, understanding and adhering to these guidelines will not only simplify vendor evaluations but also pave the way for a future where AI drives safety, mitigates growing workforce shortages and enhances patient outcomes through thoughtful and standardized implementation.
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