Federal plan targets real-world data for health research: Report

The federal government is looking to expand the use of real-world data in health research and regulation, according to a draft strategy report obtained by Politico.

Here are six things to know about the draft strategy report:

1. The draft report, issued by the Department of Health and Human Services, outlines plans to modernize the National Institutes of Health’s research methods by incorporating information collected outside traditional clinical trials.
2. The strategy calls for the NIH to build a platform to house such data, including EHRs, wearable devices, and other sources, to better study chronic diseases and potential treatments, Politico reported Aug. 15.
3. The report, which is not yet finalized, also highlights concerns about overprescribing medications, particularly among children. “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,” it states, according to Politico.
4. The NIH platform could focus on identifying alternative ways to address chronic conditions such as diabetes and hypertension, emphasizing lifestyle interventions like diet and exercise.
5. The report also suggests that the Food and Drug Administration could use real-world evidence to monitor the effects of medical products after they receive approval. Additionally, it calls for research into how AI could support chronic disease care, including earlier diagnoses, personalized treatments, patient monitoring, and predictive models to reduce hospitalizations.
6. The draft strategy includes measures to increase oversight of direct-to-consumer pharmaceutical advertising. The report says HHS, the Federal Trade Commission, and the Department of Justice would target social media influencers and telehealth companies that may provide misleading information about medications, Politico reported.

The draft report remains subject to change as the federal agencies finalize their plans.

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