Categories

Month: February 2026

Will HHS Enhance or Stall the Promise of Artificial Intelligence for Healthcare?

By STEVEN ZECOLA

In its Strategy for Artificial Intelligence (V.3), the Department of Health and Human Services (“HHS”) acknowledges that: “For too long, our Department has been bogged down by bureaucracy and busy work.” HHS promises that it will accelerate artificial intelligence (“AI”) innovation, including “accelerating drug and biologic approvals at the FDA.”

History shows that well-intended but cumulative regulatory intervention – more so than scientific complexity – is the primary deterrent to rapid technological progress. If AI is subject to the typical pattern of regulatory creep, its potential to accelerate drug discovery and development will be significantly reduced. To avoid this outcome, HHS should develop a plan that is premised on a zero-based regulatory approach. That is, each new technology such as AI should start with a clean slate and only the minimum requirements deemed necessary to show effectiveness and safety should be applied in the approval process for that technology.

The Pace of Innovation

Medical innovation has lagged the pace in the other sectors of the economy. As Dr. Scott Podolsky of Harvard Medical School observed: “Medicine in 2020 is much closer to medicine in 1970 than medicine in 1970 was to medicine in 1920.” Podolsky points to breakthroughs such as antibiotics, antihypertensives, antidepressants, antipsychotics, and steroids that have not been met with same impact as innovations in the later 50 years.

Two explanations have been offered for this phenomenon: 1) the inherent complexity of biological processes; and 2) the regulatory approval process.

As a benchmark for comparison to the following case studies, the development of 4G communications spanned less than a decade, with discussions starting around 2001, technical specifications being released in 2004, and the first commercial networks launching in 2009.

Regulatory Intervention in New Technologies

  1. The Human Genome (Great Science Leads to Regulatory Paralysis)

The Human Genome Project (HGP) ran from 1990 to 2003, and has been lauded as one of the world’s greatest scientific achievements. The project identified the specific location of genes and DNA, creating a “roadmap” of the human genetic code and facilitating the identification of disease-related genes.

The HGP focused on balancing rapid scientific progress with ethical safeguards. Oversight was primarily managed through internal ethical programs and international data-sharing agreements rather than a single overarching legislative or regulatory body.

Under this structure, the HGP beat its target date by two years. That is to say that the complexity of the problem did not cause any delays, and progress was not impeded by the standard drug-approval bottleneck.

However, once the genetic roadmap was handed off for drug discovery and development, progress slowed dramatically.

Continue reading…

Arnold Ventures Part II “Structuring Information Felicitously”

By JEFF GOLDSMITH

In the first part of our look at Arnold Ventures, we explored its business model and generous support of elite University health policy experts to further an ambitious health policy agenda. In this second part, we will explore some of the questions raised by Arnold’s aggressive approach.

Zack Cooper is an Associate Professor of Economics and Health Policy at Yale University*. He is the academic investigator at the heart of the so-called the 1% Solution, an Arnold Ventures funded project which encompasses most of its health policy agenda. The core idea of the “1% solution” is that while comprehensive health reform (e.g. “Medicare for All”) may not be achievable, pursuit of a bevy of policy goals with smaller price tags could generate savings that could be reinvested in policy improvements.

Cooper was the object of unwanted press scrutiny for receiving extensive sub rosa funding from United Healthcare for research work and writing instrumental in the enactment of the No Surprises Act in 2021, which was aimed at controlling out-of-network health insurance billing. United was expected to be the largest single beneficiary of this legislation. (The biggest “surprise” emerging from the No Surprises Act was that providers are winning 80% or more of the independent mediations of these disputes, suggesting that it was health insurers, not providers, who were gouging the public).

According to Arnold’s 990s, Cooper and his Yale policy shop, the Tobin Center for Economic Policy, received over $5 million from 2018 to 2024. Of this amount, $700 thousand funded the 1% Project itself, including more than a dozen papers by academic colleagues on topics ranging from surprise billing to PBM reforms to site neutral outpatient payment to hospital market concentration.

As part of this project, Cooper and a University of Chicago colleague, Zarek Brot-Goldberg, published a paper in early 2024 of the economic impact of hospital mergers: “Is There Too little Anti-trust Enforcement in the Hospital Sector?” which found that 20% of hospital mergers had an adverse economic impact on their communities. The alternative off-message headline, “80% of hospital mergers had no adverse economic on their communities” never surfaced.

However, a follow on piece got wide circulation thanks to a June, 2024 Wall Street Journal article, which exposed it to millions of readers without any reference to Arnold Ventures funding. The paper, which featured an astonishingly complex multivariate econometric model, was originally published by the National Bureau of Economic Research (NBER is also funded by Arnold Ventures). This paper linked hospital mergers to widespread layoffs in the communities where the mergers took place and a subsequent wave of suicides and drug overdoses (!).

Continue reading…
assetto corsa mods