The role of artificial intelligence in healthcare is accelerating. Innovations in AI are enabling organizations to scale operations, streamline processes, and improve patient experiences. But, the adoption of new technology comes with a crucial responsibility to ensure compliance and patient safety.
Authenticx General Counsel Erika Sylvester and CPO Eric Prugh held a webinar to break down the developing AI regulatory landscape and its impact on the healthcare industry. Watch the webinar on-demand here.
Key Takeaways:
- U.S. AI regulations are still evolving, with 27 states considering legislation. Governing bodies like the FDA are issuing communications that slowly reveal thoughts and considerations about future guidelines around AI use.
- The European Union AI Act (EU AI Act) is the most established regulatory guidance and takes a risk-based approach, putting the ownership on AI vendors to mitigate risk on the consumer’s behalf.
- Authenticx created a solution to automate the detection and escalation of safety events like adverse events, product quality complaints, and more.
The current state of AI regulations and legislation
AI regulation is a global focus – and while in-depth guidelines have yet to be established, each country is working to define standards and strategies around artificial intelligence.
AI regulations in the United States
Currently, there is no comprehensive federal AI regulation in the United States. However, an Executive Order released in October 2023 initiated steps towards developing U.S. regulatory standards. It is important to note that this executive order is not legislation and may be rescinded in the future.
Individual governing bodies within the United States are already taking initiatives to protect consumers’ health and safety. The SEC and FTC have warned against “AI washing” and false advertising to improve consumer protection. Additionally, the FDA issued statements regarding the use of AI in the medical and healthcare space, specifically calling out the use of AI in adverse event detection.
At the state level, 27 U.S. states are considering, developing, or have already declined AI laws.
International AI regulations
The most advanced legislative framework around AI use and development is the European Artificial Intelligence Act. Passed in August 2024, the EU AI Act takes a risk-based approach centered on protecting consumers, and is expected to guide future AI regulations in the U.S. and abroad.
Ultimately, creating and implementing comprehensive legislative AI framework will take time. This is why examining common, well-intended, compliant practices that vendors proactively apply is critical to future-proofing your investment. At Authenticx, AI governance is a crucial component of what we do. Our internal principles serve as a foundation to guide our mission of providing reliable AI to our partners.
Improving compliance and patient safety with AI
Compliance events are expensive, and until now, a heavily manual process. With up to 90% of safety events reported through contact centers, it can be challenging and time-consuming to ensure they are handled appropriately.
Authenticx has developed a solution to automate the detection and escalation of conversations that contain an adverse event. Our models are purpose-built for healthcare and continuously trained by in-house analysts, rather than relying on call center scripts alone, to accurately and reliably distinguish between adverse and safety events.
The Authenticx Safety Event Suite features workflow automations and streamlined adverse event review and reporting to eliminate manual processes, ensure compliance, and improve patient safety.
Interested in seeing the Authenticx Safety Event Suite in action? Request a demo.
Watch the on-demand webinar here.
About Authenticx
Authenticx was designed to solve the unique problems in healthcare, automating manually intensive and error prone processes to eliminate risk and improve patient safety. Request a demo of our Safety Event Suite to see how we can help you save time, money, and limit your risk exposure with automated compliance solutions.
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