As we await proposed HHS regulations on interoperability and patient access to data, and as more companies than ever before are collecting and using data to power advanced data analytics, artificial intelligence, and machine learning to improve health care quality and delivery, it is important to understand the scope and limitation of protections and the applicability of the HIPAA Privacy Rule.
Patients, providers and caregivers now have access to a wide array of devices and applications to manage and track patient health, improve treatment adherence, and better coordinate care. Large technology companies, athletic gear manufacturers, and others are entering a rapidly growing consumer health technology market. They are developing new technologies including tracking apps, wearables, and social networks that are increasingly integrated into patients’ daily lives. With an estimated 86.7 million U.S. consumers owning wearable devices by 2019, patients are generating billions of data points that provide insight into their health. Yet many of these companies are not subject to existing privacy protections under HIPAA, creating a significant gap in consumer protections.
At the same time, HHS is pushing for greater interoperability and patient access to data to address a challenge that remains widespread even after the investment of billions of federal dollars into the adoption of electronic health records. Agencies are encouraging and mandating easier availability of electronic health data, through current and anticipated CMS and ONC regulations and through a variety of government initiatives such as: 1) Blue Button and MyHealtheData; 2) incentivizing the adoption of open APIs; 3) developing new fee-for-service payment policies regarding remote monitoring and virtual care reimbursement; and 4) launching Sync for Science, a technical standard for facilitating patient-mediated data exchange for research. Consumers and companies alike seek guidance on the implications of collecting, storing, maintaining, and commercializing personal health data.