Artificial Intelligence (“AI”) is currently the hottest topic in technology and is being leveraged by nearly every industry to reduce costs, improve outcomes, and streamline services. The healthcare industry is no different and AI has been used successfully by certain specialties in medicine, like radiology, for years.
As AI applications have grown in market share, so too have the calls to begin the lengthy process of regulating this new technology. Just last month, Health and Human Services (“HHS”) released the “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” rule (“Transparency Rule”) to begin regulating healthcare AI applications and technologies.
The Transparency Rule is likely to have broad effects on the development of new AI products. The Transparency Rule requires developers of certified health IT (“HIT”) to disclose information about the algorithms they use, including their purpose, intended use, data used for training, and potential risks. The Transparency Rule will also revise existing regulations on information blocking to encourage the secure and seamless exchange of electronic health information (“EHI”) between different healthcare systems. Finally, the Transparency Rule emphasizes the importance of developing and using AI algorithms in a fair and unbiased manner. Developers are required to consider potential biases in their algorithms and take steps to mitigate them.
Currently, the Transparency Rule will apply to two (2) specific groups. The first group includes developers of certified HIT, including companies that develop electronic health records (“EHR”), clinical decision support systems (“CDSS”), and other AI-powered healthcare software. The second group includes healthcare providers who use certified HIT such as hospitals, clinics, and other healthcare organizations that rely on HIT for patient care.
Healthcare AI remains a new and novel area of technology, and the rules that apply are likely to continue to evolve as new concerns are identified and issues with existing rules are recognized. It is important that individuals in this space remain diligent to ensure that they do not run afoul of both the AI specific rules and regulations, as well as the existing rules and regulations that apply to healthcare entities, companies, and providers.
As novel as a technology may seem, providers must be aware of potential scams and vaporware that overpromises but underdelivers. As many industries rush to incorporate AI in a meaningful way, healthcare providers must approach vendors with a healthy dose of skepticism to protect their practices and patients. As with any other vendor, providers need to vet any business partner thoroughly with the assistance of counsel to avoid running afoul of the numerous state and federal regulations that apply to healthcare.
Frier Levitt has a wealth of experience assisting healthcare companies in navigating the vast regulatory landscape that governs the business of health. From founding through growth, we have attorneys who can assist your company at any stage in managing compliance with federal and state rules. For assistance with healthcare regulatory compliance, contact Frier Levitt today.
