“Patients own their health data, which is more valuable if shared.” –Deven McGraw
Meeting Summary
Getting access to and controlling one’s medical records can increase a patient’s (or caregiver’s) knowledge about their disease. This knowledge is power. It can enable a patient (or caregiver) to actively participate as a co-pilot with their medical team in guiding their testing and treatment decisions. Advanced cancer patients also want to share their health data with experts and peers, and they want to learn what has worked and hasn’t worked for other patients with a similar profile. Patients’ health data is more valuable if shared.
Deven McGraw is uniquely qualified to talk about the legal and regulatory situation for patients who want to get copies of their medical records and share them. She is Lead, Data Stewardship and Data Sharing, at Invitae, a genomic medicine company that provides clinical genetic testing and helps patients gather their full records (genetic and phenotypic) for use in seeking care and advancing research. Previously, she was a co-founder and the chief regulatory officer for Ciitizen, a consumer-health technology start-up. She directed U.S. health privacy and security as Deputy Director, Health Information Privacy, at the HHS Office for Civil Rights and Chief Privacy Officer (Acting) of the Office of the National Coordinator for Health IT. She is widely recognized for her expertise in health privacy. She directed the Health Privacy Project at the Center for Democracy & Technology for six years and led the privacy and security policy work for the HITECH Health IT Policy Committee. She also served as the chief operating officer of the National Partnership for Women and Families. She advised health industry clients on HIPAA compliance and data governance while a partner at Manatt, Phelps & Phillips, LLP. Deven graduated magna cum laude from Georgetown University Law Center and has a Masters of Public Health from Johns Hopkins University.
Patient rights for access to health information depends mainly on HIPAA (The Health Insurance Portability and Accountability Act of 1996), which has been around for decades, and the Cures Act, which was signed into law in 2016, and includes information blocking rules. There has been progress in making health information more accessible to patients through technology, but more needs to be done.
What are the barriers to accessing and sharing healthcare data that patients and caregivers face? What are your legal rights?
The health system facilitates gathering data for drug discovery by researchers, but accessing and sharing clinical data with physicians or peers for clinical decision-making isn’t as easy. The information blocking rules and HIPAA give you a right to any data that has been created that is used for clinical guidance or to seek payment for care. Beyond information stored in medical records, you also have a right to access the underlying raw data files and to images. You cannot use the law as a way to force diagnostic companies or providers to generate data that they haven’t already generated.
What should patients (and caregivers) do to access and manage their healthcare data?
We’re moving beyond HIPAA to improve patient access to their health data, including the ability to get that data through a completely online experience, such as through an app. HIPAA access is being more robustly enforced. New information blocking rules prioritize access by patients or apps acting on their behalf. Patients can get access through portals, apps/APIs, and other mechanisms.
Do the rules give patients control of their tissue and other sources of their health data?
The access rules apply only to data, and not to specimens. A biospecimen is not going to be accessible by you.
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