Hidden in the United States 2023 federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid, lies a little noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which went into effect earlier this year, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan. It also gives the FDA $5 million to see a higher security standard through. Historically, the agency has lacked the resources to keep up with rapidly-evolving security threats, or the authority to force device makers to comply with its draft guideline.
There are also legal dangers for healthcare providers. If a clinician relies on an AI assisted support prompt without taking all other clinical information into consideration, that could pose a risk. Physicians, clinicians and nurses need to understand how artificial intelligence works, and most importantly, understand that they are still accountable for making the final decision. Harvey Castro, MD and ChatGPT expert, says “Acting on ChatGPT’s response without vetting the information places doctors as serious risk of a lawsuit.” He continues, “Sometimes the response is half true and half false… Physicians really have to make sure they are vetting the information provided.”
One thing is sure, is that the media will provide extensive coverage of AI-related medical adverse events. This will be similar to the type of media coverage for Tesla’s self-driving cars when systems fail and accidents happen.
The flip side of this however, is that in the future, healthcare providers may face risks if they have not consulted with AI modalities. “AI could even, in some modalities, become the standard of care”, says Saurabh Jha, MD (radiologist) at the University of Pennsylvania.
There’s also the risk and cost of the AI generated response recommending unnecessary procedures, or not recommending a standard one that’s normally part of standard of care.
While there have not been any AI lawsuits filed to date, experts believe that they make an appearance soon. “At some point, a provider will make a decision that is contrary to what the AI recommended. The AI may be wrong, or the provider may be wrong. Either way, the provider will neglect to document their clinical reasoning, a patient will be harmed, and we will have the first AI claims, said Sue Boisvert, senior patient safety risk manage at The Doctors Company, an American medical liability insurer. 
Then there’s the issue of when ChatGPT hallucinates. This refers to a response that AI has generated, that sounds valid, but actually is incorrect or even unrelated to the correct context.
For more articles in the series on Artificial Intelligence, go to:
- An AI (Artificial Intelligence) Primer
- AI’s Capabilities
- AI Achievements
- ChatGPT (or any AI bot) and Your Medical office
- Teaching AI in Medical School
- Patient Trust in AI Chatbots & ChatGPT
- Competitors to ChatGPT
- AI Policies and Regulatory Challenges
- Ai Bias
- AI’s Limitations, Concerns and Threats
- What AI Can’t and Shouldn’t Do
- AI and Accountability
- The Future of Generative AI
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