Draft MAHA report emphasizes real world data

Politico

9 hours ago

WASHINGTON WATCH
The federal government wants to use real world data in health research and regulation, according to draft strategy documents obtained by POLITICO.
The draft strategy discusses how the Department of Health and Human Services would address a variety of health concerns, including chronic disease. As part of that work, the report discusses updating how the National Institutes of Health does research by using real world data, or information gathered outside of traditional clinical trials. To do that, the report calls on the NIH to build a platform for housing this information.
The draft report is not finalized and therefore subject to change. However, if this new platform remains part of the agenda, it would pull in claims information from electronic health records and wearables, among more traditional kinds of data, according to the document. Researchers would be tasked with analyzing the information to understand the causes of chronic disease along with potential treatments.
The report highlights a concern of Kennedy's and his supporters that Americans are overmedicated. 'There is a concerning trend of overprescribing medications to children, often driven by conflicts of interest in medical research, regulation, and practice. This has led to unnecessary treatments and long-term health risks,' the report says.
The proposed NIH research platform would likely be aimed at finding alternative methods of reversing chronic conditions, like diabetes and hypertension, through diet and exercise.
The report also calls for the Food and Drug Administration to incorporate real world evidence to track the impacts of regulated medical products post authorization or approval.
More AI: The report says HHS would research how artificial intelligence could be deployed to assist with chronic disease care — including how it can be used to diagnose people earlier, personalize treatment and monitor patients as well as use predictive models to prevent hospitalizations.
What else: Health influencers beware: According to the draft report, HHS would increase oversight on direct-to-consumer pharma advertising. In particular, the department, the Federal Trade Commission and the Department of Justice would crackdown on social media influencers and direct-to-consumer telehealth companies that mislead consumers about pharmaceutical products they promote.
WELCOME TO FUTURE PULSE
This is where we explore the ideas and innovators shaping health care.
Former Surgeon General Jerome Adams, who served during the first Trump administration, took to X Friday to call out NIH's cancellation of $500 million for mRNA research as 'dangerous.'
'His misleading claims threaten public health and undermine President Trump's greatest and most life saving contribution to humanity,' he wrote of NIH director Jay Bhattacharya.
Share any thoughts, news, tips and feedback with Carmen Paun at [e-mail], Ruth Reader at [e-mail] or Erin Schumaker at [e-mail].
Want to share a tip securely? Message us on Signal: CarmenP.82, RuthReader.02 or ErinSchumaker.01.
AROUND THE NATION
The battle over children's online safety laws intensified Thursday as the U.S. Supreme Court allowed a so-called age-gating law in Mississippi to stay in effect, POLITICO's Gabby Miller reports.
On Thursday, the justices blocked an emergency appeal while NetChoice's challenge to Mississippi's ID law plays out in a federal trial court. The trade group, which represents Meta, YouTube and X,claims the law violates its members' free speech rights.
The 2023 law requires online platforms with a substantial portion of pornographic content to verify that users are 18 or older.
Why it matters: A growing number of parents have concerns over how social media — and now entertainment-based chatbots — are affecting youth mental health.
States are increasingly restricting access to social media platforms and sites with explicit content. For example, the Mississippi law asks social media sites to make 'reasonable effort' to shield minors from harmful content.
However, laws and policies that require sites to verify their users' ages haven't fared well in court. Justice Brett Kavanaugh wrote in his concurrence that NetChoice would likely succeed in demonstrating that the Mississippi law would violate its members' First Amendment rights under the court's precedents.
Part of the problem is that some age-verification laws interfere with minors' lawful access to protected speech. Netchoice has won several lawsuits against age-verification laws on that basis.
But, but, but: That's not to say all age-verification laws are moot.
Another policy approach is app store age verification. Those laws require mobile app stores to verify their users' ages and obtain parental consent before minors can download apps. This practice might be able to withstand legal scrutiny because app stores require users to sign contracts to download apps, and contracts signed by minors aren't legally enforceable. This approach might not bump up against First Amendment rights because it doesn't seek to restrict certain content.
What's next: The Mississippi law is just one among nearly a dozen other similar state regulations, and First Amendment experts, state leaders and the tech industry are anxiously awaiting Supreme Court rulings that will determine their fates.