Are you surprised yet?
In our last blog, I stunned myself and maybe most of the readers of this blog- we have over 1,500,000 medical related publications issued annually in the world. It is impossible for anyone to keep up. I would not be surprised if at large teaching and research medical centers like Jackson Memorial Hospital (Miami, Florida) the largest single hospital facility in the U.S. with 1,500 beds, there is published research that is not known by most of the doctor serving there.
Reviewing large amounts of data is what Artificial Intelligence (AI) is designed for and amazing at doing. We would argue that Large Language Models (LLMs) are not the best for any healthcare application, even for the ones it can easily do like Radiology, Pathology and Genetics. We remain convinced, and I talk to doctors regularly, that today the time required (prompting and adjusting), system cost vs, benefit, accuracy and legal risk is too much to make it work in general healthcare. But that same information is informative to consumers and could be lifesaving.
Pre and Post Trump FDA and AI
Many of the policy website of the U.S. Government are being replaced. I was surprised at first, but someone who knows told me this seems to be normal or maybe expected. There was a lot of commentary by the now former FDA Administrator on AI, that we have referred to. I have some slides of a presentation titled “Strategic Plan for the Use of Artificial Intelligence in Health, Human Services, and Public Health” dated January 2025, that I will use in Part III of this series. First, some more recent commentary from Former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, that as part of the American Enterprise Institute wrote recently in The Journal of American Medical Association (JAMA) on AI (link below). I am personally not a fan of Dr. Gottlieb, as his Covid commentary did not stand well by the test of time, but he did disclose he was involve with as I recall two pharmaceutical companies. In this JAMA commentary he discloses “Dr Gottlieb reported receiving payments for serving on the board of directors for Pfizer Inc, Xaira, Tempus AI, and Illumina Inc and being a partner with New Enterprise Associates”.
Here is my summary of his published work. Dr. Gottlieb discusses the rapid advancement of artificial intelligence (AI) in medicine, particularly the potential of artificial general intelligence (AGI) to revolutionize clinical practice. I am not a doctor, and I am committed that AI will change healthcare, but I am very doubtful that real AGI is around the corner, or that it will be independent of U.S. trained, residencied and licensed MDs/DOs.
However, he points that AGI, unlike current narrow AI, could enable machines to synthesize vast amounts of patient data [hard to do with HIPAA today], providing complex medical insights. He notes that recent changes [predating the Trump Administration] in the FDA’s policies have created regulatory uncertainty. The agency’s updated stance may classify AI-driven tools that analyze diverse medical data as medical devices, subjecting them to stringent oversight. This shift could hinder AI’s seamless integration into Electronic Health Record (EHR) systems, limiting its ability to enhance patient care.
The article highlights how prior legislation, such as the 21st Century Cures Act, aimed to balance innovation with regulation by exempting certain clinical decision support software (CDSS) from FDA oversight. By the way, CDSS is not AI as we define it today, it was 100% rules based. To continue, Dr. Gottlieb highlights that the new FDA guidelines issued in 2022 have tightened these exemptions, considering factors such as “automation bias” and “time criticality.” As a result, AI tools embedded in EHRs may now be classified as regulated medical devices if they provide comprehensive analysis that clinicians might rely on entirely. He believed that this regulatory approach risks discouraging developers from integrating AI capabilities into EMRs, forcing healthcare providers to rely on standalone AI tools that may be less effective due to workflow disruptions.
Dr. Gottlieb argues that the FDA should return to the intent of the 21st Century Cures Act and adopt a regulatory framework that assesses AI tools based on their function rather than their data-processing sophistication. He suggests that AI-powered decision support tools should be allowed to augment clinicians’ information without requiring premarket approval, as long as they do not autonomously diagnose or prescribe treatments. Instead, real-world evidence could be used in the post-market to validate AI’s role in improving medical decision-making. By taking this approach Dr. Gottlieb argues the FDA could support innovation while ensuring patient safety, ultimately unlocking AI’s full potential in healthcare.
Our View On EHR and AI
I am not a doctor but guess what- I have been managing medical centers of all types and at-risk providers for 30 years, plus built entire EHR platform (PWeR® with billing and practice management) that includes sophisticated CDSS. CDSS was require in obtaining a U.S. Government certification of our EHR, it was hard work, but our team did it and it worked well. I am also a huge advocate of AI in just about any industry and for sure in healthcare, however we have dozens of clinical researcher studies that confirm AI is not ready to play a role in direct medical care, outside of Radiology, Pathology and Genetics, those are pure science, and AI is very good at that. EHR use S.O.A.P notes as a standard. That stands for Subjective, Objective, Assessment, Plan. I hate to agree with the FDA summarily, and my belief could be in conflict with the new FDA administration. But we will find out. When there is a death, and the trial lawyers go at it. Yes, AI in EHR should be highly suspected. Who will put the check on the AI? Another AI?
I know doctors using over the counter AI platforms for “supplementing” their knowledge and information. This is the disclosure one of these platforms has, really a warning:
**“**XX is an experimental technology demonstrator. XX does not provide medical advice, diagnosis or treatment. User questions and other inputs on XX are not covered by HIPAA. It is the responsibility of the user to ensure questions do not contain protected health information (PHI) or any information that violates the privacy of any person.”
A better use of AI today- Empowering the Consumer
Today, a closed, carefully curated AI, with access to the Consumer’s real and current medical information can be of great use. The Consumer instead of using “Dr. Google” or importing their personal health data into a Large Language Model (LLM) could have a closed system review actual data, physician’s SOAP notes, laboratory, diagnostic reports, pharmaceutical summaries, and compare to clinical research and medica journals and reports to inform the Consumer not on what to do, or self-treat, but to share with and discuss with their medical provider. We need to use AI to empower the consumer.
About HealthScoreAI ™
Healthcare is at a tipping point, and HealthScoreAI is positioning to revolutionize the industry by giving consumers control over their health data and unlocking its immense value. U.S. healthcare annual spending has exceeded $5 trillion with little improvement in outcomes. Despite advances, technology has failed to reduce costs or improve care. Meanwhile, 3,000 exabytes of consumer health data remain trapped in fragmented USA systems of 500 EHRs, leaving consumers and doctors without a complete picture of care.
HealthScoreAI seeks to provide a unique solution, acting as a data surrogate for consumers and offering an unbiased holistic view of their health. Giving Consumers tools to respond to denial of care by insurers. By monetizing de-identified data, HealthScoreAI seeks to share revenue with consumers, potentially creating a new $100 billion market value opportunity. With near-universal EHR adoption in the USA, and advances in technology, now is the perfect time to capitalize on the data available, practical use of AI and the empowering of consumers, in particular the 13,000 tech savvy baby boomers turning 65 every single day and entering the Medicare system for the first time. Our team, with deep healthcare and tech expertise, holds U.S. patents and a proven track record of scaling companies and leading them to IPO.
Noel J. Guillama-Alvarez
https://www.linkedin.com/in/nguillama/
