The 21st Century Cures Act, health IT and data



The 21st Century Cures Act – passed overwhelmingly by Congress in recent days – will have broad implications on health IT and medical technology.

The $6.3 billion bill is probably best known for:

  • Accelerating the path to FDA approval of drugs and medical devices by giving the Food and Drug Administration new authority in this area;
  • Providing $4.8 billion to the National Institutes of Health (subject to annual appropriations), including $1.8 billion for Vice President Joe Biden’s Cancer Moonshot initiative and funding for the president’s Precision Medicine and BRAIN initiatives;
  • Allocating $1 billion over two years to states to fight opioid abuse;
  • Being opposed by Sens. Elizabeth Warren, D-Mass., and Bernie Sanders, I-Vt., and a few other Democratic leaders, who denounced the bill as a handout to the drug industry. (The bill passed the Senate 94-5.)

Writing in The New York Times last month, Jennifer Steinhauer and Sabrina Tavernise described the legislation as addressing “problems that touch nearly every American life.”

The Cures bill has some notable health IT provisions:

  1. Creates a reporting system on electronic health record (EHR) usability; interoperability and security by stakeholders.
  2. Sets up a provider directory aimed to facilitate data exchange and favoring solutions to interoperability originating in the private sector;
  3. Directs the Government Accountability Office to evaluate the current state of so-called “patient matching“ to their EHRs and determine steps the Department of Health and Human Services (HHS) can take to link patients to their records and avoid duplication.
  4. Authorizes the HHS Office of the Inspector General to investigate and penalize data blocking offenses;
  5. Broadens the Office of the National Coordinator on Health IT (ONC)’s authority over health IT certification, and combines the ONC’s Health IT Policy and Standards Advisory Committees.

Thinking about the impact of the Cures bill only in the context of EHRs misses the bigger picture, however. Funding for BRAIN, Precision Medicine and the Cancer Moonshot initiatives will accelerate scientists’ creation and use of large patient data sets and open up those data sets to researchers to advance research development.

“We should think of technology as neither revolutionary or remarkable unless it helps everyone,“ said D.J. Patel, chief U.S. data scientist with the White House, speaking at the Health 2.0 conference this fall about the importance of open data for these three big initiatives that received funding via the Cures bill. You can hear Patel talk about data and the Cures bill on NPR’s Science Friday on Dec. 9.

1 thought on “The 21st Century Cures Act, health IT and data

  1. Norman Bauman

    The big problem with the 21st Century Cures Act is that it will weaken the standards of evidence, notably randomized, controlled trials, that were put in place to prevent another thalidomide.

    In the U.S., the way to get a bad law passed that benefits wealthy, politically influential interests but is bad for the people as a whole is to bundle it with a big bill that has other provisions that are so essential that Congress and the President must pass them.

    The 21st Century Cures Act is one such bill. We as journalists have trouble getting the general public (and even doctors) to understand evidence-based medicine — the difference between association and causation, the difference between clinically meaningful and secondary endpoints, and why you can’t know whether a treatment is effective without controlled trials.

    This Act ignores evidence-based medicine and allows drug and device manufacturers to sell their products without those standards of evidence.

    We as journalists should follow our own standards of evidence — getting both sides of the story.

    A responsible journalist must talk to the critics of the Act. Among them are Avorn and Kesselheim:
    The 21st Century Cures Act — Will It Take Us Back in Time?
    Jerry Avorn and Aaron S. Kesselheim
    N Engl J Med 2015; 372:2473-2475
    June 25, 2015
    DOI: 10.1056/NEJMp1506964

    An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two thirds of new drugs are approved on the basis of studies lasting 6 months or less — a potential problem for medications designed to be taken for a lifetime. Once the Food and Drug Administration (FDA) starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments.

    Nonetheless, as introduced, the 21st Century Cures Act instructs the FDA to consider nontraditional study designs … encouraging the use of “shorter or smaller clinical trials” for devices and the request that the FDA develop criteria for relying on “evidence from clinical experience,” including “observational studies, registries, and therapeutic use” instead of randomized, controlled trials for approving new uses for existing drugs …. there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy.

    The bill would also encourage the FDA to rely more on biomarkers and other surrogate measures rather than actual clinical end points in assessing the efficacy of both drugs and devices…. Bevacizumab (Avastin) delayed tumor progression in advanced breast cancer but was shown not to benefit patients. Similarly, rosiglitazone (Avandia) lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction. In 2013, patients began to receive a new drug for tuberculosis approved on the basis of a randomized trial relying on a surrogate measure of bacterial counts in the sputum — even though patients given the drug in that trial had a death rate four times that in the comparison group, mostly from tuberculosis.

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