Authors associated with the NCHR published a study "examining how often the different approval or clearance processes were used for medical devices that were subsequently recalled for life-threatening problems.

[4][failed verification] 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.

[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.

[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 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.