When innovation transcends regulation: Lessons from IV spas to artificial intelligence
We hear that in addition to “changing the world,” innovation must “move fast and break things.” This feels like gospel for Silicon Valley, or certainly just part of the current narrative. But if you act too quickly, without consciously answering the “why” and “what”, you may damage some serious problems that cannot be repaired. Certain innovations, particularly those known as “asymmetric goods,” enter the market without real risk transparency. This is a problem because when profit-driven motives are not scrutinized, you lose control.
Today, the most obvious example is the widespread integration of artificial intelligence in nearly every industry—not the least of which is healthcare and health technology. The problem is that when risks are not transparent, buyers cannot make informed decisions about trade-offs and benefits. Without informed buyers, the growth of venture capital compounds risk.
Case in point: the recent rise in IV clinics, or “IV spas,” which deliver a cocktail of vitamins, minerals and medications directly into the bloodstream. They are at the intersection of consumer services and medical practice, where governance, credentialing, dispensing practices and compounding procedures determine whether care is safe or dangerous.
IV clinics are a $15 billion business that is growing rapidly in volume and value, but its claims and benefits are often difficult to review. The reality is that without an appropriate legal framework, there are no clear incentives for owners to behave in accordance with medical standards.
In a recent article, JAMA highlighted the risks and unique relationship between health care delivery and regulation, specifically how these lines are drawn. Before last year, 32 states had issued position policy statements on medical spa care delivery and oversight expectations, but none had formal legal oversight. That changed in 2023 after an unfortunate, tragic death in Texas.
In the wake of this tragedy, Texas HB 3749 — “An Act Relating to the Regulation of Elective Intravenous Therapy” — was passed. Also known as “Jennifer's Law,” it involves standardizing core categories of supervision so that they more closely resemble traditional medical practice.
Regulation aims to create a system that correctly assesses, communicates and manages risks. It also establishes a framework of recommendations and finalizes an accountability framework. In health care, errors may escalate to civil or criminal charges depending on the “degree of intent.” According to Jennifer's Law, a medical plan must be developed after an initial evaluation before proceeding with intravenous treatment. Management itself must be performed by a licensed health care professional and include patient monitoring. It is a criminal offense to perform IV therapy without a license.
These are basic expectations in medicine and now apply in settings without them.
None of this is new to doctors. Most take the Hippocratic Oath at the beginning of their careers and commit to abiding by the creed “do no harm” and practicing medicine responsibly and humbly. Yes, the practice is constantly evolving. New tools emerge. New knowledge and standards of care are developed. Taking action or choosing not to act can heal or hurt and should be guided by judgment and rules. Within this professional ethics lies a strong and long-standing legal framework designed to protect patients and hold decision-makers accountable when harm occurs.
The IV clinic example illustrates why similar oversight must be coupled with other rapidly evolving innovations. The public is faced with ambiguous, asymmetric information—whether it’s about intravenous treatments or artificial intelligence health care tools—and is often unable to assess risks or verify claims for themselves.
We should never wait until tragedy strikes to force conversations around clear governance and accountability. Oversight must evolve alongside innovation to protect people before harm occurs. IV clinical cases show us the path: define minimum standards, require competent supervision, mandate appropriate monitoring, and make accountability a reality. Now, apply the same approach to artificial intelligence in health technology and the next innovations that will emerge in three to five years.
The question is not if the problem will arise, but when. The responsible response is to create an intelligent framework now.
Photo: YDL, Getty Images
Jack Stockert, MD, is Managing Director of Health2047. He is passionate about driving system-level change through collaboration and innovation to improve the way people live and how physicians practice within the healthcare system. Jack's experience as a physician, combined with his strong analytical skills and McKinsey & Company's well-established health care systems perspective, provides a broad range of skills and a contextual and deep understanding of health care challenges and opportunities. Jack also has entrepreneurial experience founding the venture capital-backed company HealthEngine, global health exposure experience working at the World Health Organization, and financial and investment experience at Morgan Stanley. He received his medical degree from the University of Chicago Pritzker School of Medicine and his MBA from the University of Chicago Booth School of Business. He received his BA, cum laude, from the University of Chicago.
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