National Center for Health Research explained

National Center for Health Research
Type:Think tank
Founded Date:1999
Founder:Diana Zuckerman
Location:Washington, D.C.
Key People:Diana Zuckerman, President
Product:Health and medical information and assistance
Focus:Conducts and scrutinizes research to improve the health and safety of adults and children.

The National Center for Health Research (formerly known as the National Research Center for Women & Families) is a Washington, D.C. based non-profit organization founded in 1999. Its stated mission is conduct, analyze, and explain health research to the public.[1] The President of the organisation is Diana Zuckerman.

In 2014, the organization changed its name from the National Research Center for Women and Families to the National Center for Health Research.

Research

In February 2011, Center staff concluded a study into the various alternative approval processes for medical devices at the Food and Drug Administration (FDA). Authors associated with the Center published a study "examin[ing] how often the different approval or clearance processes were used for medical devices that were subsequently recalled for life-threatening problems."[2] The study recommended that the FDA needed to apply stricter criteria for approving implanted medical devices and those used to diagnose serious illnesses - a recommendation that was also supported by an editorial at the same subject.[3] The study resulted at a hearing in the U.S. House of Representatives.

In April 2011, president Diana Zuckerman testified before the U.S. Senate Special Committee on Aging about the study findings.[4]

In 2014, the organization published a study in the JAMA Internal Medicine journal about the scientific evidence submitted to the FDA to support the marketing of implanted medical devices under the agency’s 510(k) review process. The study concluded that most of the implanted devices were not required to submit data from clinical trials or scientific evidence of safety or effectiveness before they could be sold.[5]

In 2017, the NCHR staff published a paper in Milbank Quarterly criticizing the FDA for its failure to safeguard electronic health records and other device software from hacking and other cybersecurity threats. They stated “current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market”.[6] They added that legislative changes resulting from the law entitled the 21st Century Cures Act “will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.”

The center published another study in Milbank Quarterly in 2018 called “Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?”.[7] The study investigated whether new, high-risk medical devices had been proven safe and effective for women, minorities, or patients over 65 years of age. The paper concluded that most studies did not conduct subgroup analysis on all these major demographic groups, thus providing no information about safety or effectiveness for most patients.[7]

Awards

Two awards are given by the center each year:

Publications

Notes and References

  1. Web site: Home Page . 2022-09-08 . National Center for Health Research . en-US.
  2. Zuckerman . Diana M. . Brown . Paul . Nissen . Steven E. . Medical Device Recalls and the FDA Approval Process . Archives of Internal Medicine . 13 June 2011 . 171 . 11 . 1006–11 . 10.1001/archinternmed.2011.30 . 21321283 .
  3. Redberg . Rita F. . Dhruva . Sanket S. . Medical Device Recalls: Get It Right the First Time . Archives of Internal Medicine . 13 June 2011 . 171 . 11 . 1011–2 . 10.1001/archinternmed.2011.27 . 21321286 .
  4. Web site: Home - United States Senate Special Committee on Aging. United States Senate. 8 August 2015.
  5. Jin . Jill . 2014-01-22 . FDA Authorization of Medical Devices . JAMA . 311 . 4 . 435 . 10.1001/jama.2013.286274 . 24449330 . 0098-7484.
  6. Ronquillo . Jay G. . Zuckerman . Diana M. . Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health . The Milbank Quarterly . September 2017 . 95 . 3 . 535–553 . 10.1111/1468-0009.12278 . 28895231 . 5594275 .
  7. Fox-Rawlings . Stephanie R. . Gottschalk . Laura B. . Doamekpor . Laurén A. . Zuckerman . Diana M. . Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? . The Milbank Quarterly . September 2018 . 96 . 3 . 499–529 . 10.1111/1468-0009.12344 . 30203600 . 6131322 .
  8. Web site: Foremother and Health Policy Hero Awards Luncheon . 7 May 2018 . National Center for Health Research . 17 September 2019.

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