March 5, 2018. Pregnancy/postpartum represent critical periods for counseling, health promotion, and health maintenance. Providers and patients must engage in informed discussions of benefits, risks, and alternatives in order to achieve shared-decision making. However, uncertainty of drug harms present a unique challenge in the overall picture of risks and benefits.
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NCHR Letter to House Energy and Commerce Committee on Right To Try Legislation
February 22, 2018. Some terminally ill patients are willing to take big risks to have a chance to live longer, and if they want the “right to try” experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.
Read More »NCHR Comments on Changes to Medical Software Policies Due to 21st Century Cures Act
February 15, 2018. The draft guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act removes FDA evaluation of EHRs and leaves only certification by the Office of the National Coordinator for Health Information Technology (ONC) to ensure that software is both functional for providers and safe for patients. However, ONC certification is not sufficient to protect patients from problems with EHR software. For that reason, the draft guidance as written puts patients’ lives at risk.
Read More »NCHR Comments to USPSTF on Non-traditional Screening Methods for Heart Disease
February 12, 2018, USPSTF. We agree with the USPSTF that current evidence is insufficient to assess potential benefits and harms of adding the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP), or coronary artery calcification (CAC) score to the traditional risk assessments for CVD.
Read More »NCHR Comments on USPSTF Draft Screening Recommendations for Peripheral Artery Disease (PAD)
USPSTF, February 12, 2018. In order to more widely recommend ABI, we need more studies directly evaluating both the efficacy and harms. Most importantly, we encourage the USPSTF to review studies that analyze the accuracy of ABI and its effect on improving health outcomes in asymptomatic PAD patients.
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