Photo of Cara Tenenbaum

Cara is a seasoned health policy expert, advocate, and writer with almost two decades of health policy experience. That includes experience in the patient advocacy field, having been the head of policy for a small non-profit focusing on women's health. There, she handled all advocacy, including appropriations, authorizing legislation, drafting testimony, presenting testimony, preparing regulatory comment letters and working with all operating divisions of HHS, as needed. Additionally, she functioned as spokesperson for the organization, appearing on national and international TV as well as in print. Cara was at the FDA for six years, working in both the Office of External Affairs in the Commissioner's Office and the Office of the Center Director in the Center for Devices and Radiological Health. There, Cara worked on issues at the intersection of policy, legislation and advocacy, helping further the Agency's agenda with patient and provider groups.

She has worked or volunteered in the pro-choice field off and on for 20 years, including being a clinic escort, volunteering with abortion funds, and doing patient counseling at an abortion clinic.

Cara has numerous legal publications, and provides off and on the record interviews to press.

She holds a JD and MBA from Case Western Reserve University and a BA in Economics from the University of Maryland, College Park.

On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and ensure privacy protections for health data and information. In the report, Senator Cassidy highlights recent reports of breaches and violations of patients’ health data privacy and outlines several proposals to modernize the HIPAA framework and other privacy regulations.Continue Reading Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations

On November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies that can be leveraged to support DCT adoption.Continue Reading Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations

On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research the FDA is providing guidance for ensuring that technologies used are safe, appropriate, and store and transmit data appropriately. Highlights of the guidance are below.Continue Reading FDA Releases Guidance on Digital Health Technologies for Clinical Investigations