By Noel J. Guillama-Alvarez
Are You Surprised Yet?
In our previous blog, I shared a shocking statistic: more than 1.5 million medical-related publications are published annually worldwide. Keeping up with this volume is impossible. I wouldn’t be surprised if even major teaching and research hospitals like Jackson Memorial Hospital in Miami, Florida (the largest hospital facility in the U.S., with 1,500 beds) have published research that most of their own doctors are unaware of.
This is where Artificial Intelligence (AI) comes into play. AI excels at analyzing large amounts of data, and I believe it’s uniquely suited for this task. However, I’d argue that Large Language Models (LLMs) aren’t ideal for many healthcare applications, even for tasks like Radiology, Pathology, and Genetics that AI can handle. After speaking with many doctors, I’m still convinced that the time, cost, and accuracy challenges of integrating AI in general healthcare make it impractical at the moment. However, when it comes to consumer applications, AI could be a game-changer, potentially saving lives.
Pre- and Post-Trump FDA and AI
There has been a significant shift in U.S. government policy regarding AI in healthcare, which has caught my attention. Some government websites are being replaced or updated, something I was initially surprised by, but I’ve since learned this is more common than it seems. Former FDA Administrator Scott Gottlieb, MD, recently shared his thoughts on AI in medicine in The Journal of the American Medical Association (JAMA), and I’ll provide a brief summary of his views.
While I’m not a fan of Dr. Gottlieb—his commentary on COVID didn’t stand up well over time—I do appreciate his insights into AI. He acknowledges the rapid progress of AI, particularly the potential of artificial general intelligence (AGI) to revolutionize clinical practice. However, I remain skeptical that AGI is just around the corner, and I’m even more doubtful it will replace the role of U.S.-trained, licensed MDs/DOs.
Dr. Gottlieb highlights that AGI could be a breakthrough in synthesizing vast amounts of patient data, providing complex medical insights. However, he notes that regulatory uncertainty—stemming from FDA policy changes even before the Trump administration—could slow AI’s integration into healthcare. These changes could classify AI-driven tools as medical devices, subjecting them to strict oversight. This, in turn, might prevent AI from seamlessly integrating with Electronic Health Record (EHR) systems, limiting its potential to improve patient care.
The FDA’s 2022 guidelines have introduced tighter exemptions, making some AI tools embedded in EHRs subject to medical device regulations. Dr. Gottlieb argues that this regulatory approach risks stifling innovation, pushing developers toward standalone AI tools that could disrupt healthcare workflows. He suggests the FDA should reassess its stance and allow AI-powered decision support tools to assist clinicians without requiring premarket approval, as long as the tools don’t autonomously diagnose or prescribe treatments. Dr. Gottlieb believes this approach could foster innovation while ensuring patient safety.
Our Perspective on EHR and AI
While I’m not a doctor, I’ve spent 30 years managing medical centers, at-risk providers, and building EHR platforms (PWeR®) with integrated billing and practice management. My team and I worked hard to create a sophisticated Clinical Decision Support System (CDSS) that was certified by the U.S. government.
I’m a strong advocate for AI, especially in healthcare, but I think the research is clear: AI is not yet ready to play a major role in direct medical care—outside of fields like Radiology, Pathology, and Genetics. These are fields rooted in pure science, and AI excels at them. In contrast, EHRs typically use S.O.A.P. notes (Subjective, Objective, Assessment, Plan) as a standard. AI in EHRs should be treated with caution. As much as I want to support AI in healthcare, I think it’s crucial to recognize the legal risks, especially in the event of a patient death.
I know some doctors use AI platforms to “supplement” their knowledge, but one of these platforms offers a strong warning:
“XX is an experimental technology demonstrator. XX does not provide medical advice, diagnosis, or treatment. User inputs are not covered by HIPAA. It is the user’s responsibility to ensure no Protected Health Information (PHI) is shared.”
A Better Use of AI Today: Empowering the Consumer
Instead of using generic AI tools or “Dr. Google,” consumers could benefit from a closed, curated AI system that has access to their current medical information. This system could review actual medical data, including physician’s SOAP notes, lab results, diagnostic reports, and pharmaceutical summaries, alongside clinical research and medical journals. The goal wouldn’t be for AI to tell the consumer what to do or how to self-treat, but to provide valuable insights to share with their healthcare provider.
The real power of AI in healthcare lies in its ability to empower the consumer to have informed discussions with their doctors. Rather than relying on general internet searches, consumers could use AI to better understand their medical condition, giving them a stronger voice in their care and improving collaboration with healthcare providers.
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/
+1-561-904-9477, Ext 355
https://jamanetwork.com/journals/jama-health-forum/fullarticle/2830189