Permits individuals to access, and authorize sharing of, certain health data and information collected by medical device technology companies.
Summary
This bill would give individuals the right to access certain health data and information collected by medical device technology companies and, if they choose, authorize that data to be shared with the New Jersey Department of Health for further sharing with medical and academic research agencies and institutions. The authorization would be requested as part of the initial consent form before a person receives a medical device technology, and the data must be de-identified and handled in compliance with HIPAA and other applicable state and federal privacy laws.
The bill also requires medical device technology companies to provide electronic access to the health data and information they collect from an individual, including the ability to download it. If the patient is a minor, a parent or guardian may access the data and authorize its sharing. The bill defines covered medical device technology as FDA-regulated medical equipment or products with therapeutic or diagnostic value, excluding pharmaceuticals, and applies to companies headquartered or based in New Jersey that research, develop, produce, or provide such technology.
Impact
The bill would supplement Title 26 of the New Jersey Statutes by creating a patient-access and data-sharing framework for health information generated by certain medical devices. It would place new obligations on New Jersey-based medical device technology companies to offer electronic access to collected data, obtain consent for sharing at the point of initial device consent, and ensure any shared information is de-identified and compliant with privacy law. It would also involve the Department of Health as a conduit for sharing authorized data with research institutions.
Sentiment
No committee transcript or vote history is available, so there is no recorded legislative debate or roll-call sentiment to assess. Based on the bill text, the measure appears to be framed positively around patient rights, transparency, and research access to device-generated health data. The sponsor’s statement emphasizes patient ownership of granular device data and the value of making it available for medical research.
Contention
The main likely points of contention are privacy, consent, and operational burden. Supporters would likely favor expanded patient access and research use of de-identified data, while critics may question whether requiring authorization at initial consent is sufficiently clear or whether companies can reliably comply with HIPAA, de-identification, and data-sharing obligations. There may also be concern about the scope of covered companies, the handling of minors’ data, and the administrative costs imposed on New Jersey-based medical device firms.
A BILL for an Act to provide appropriations to the attorney general, the department of career and technical education, the department of health and human services, and the agriculture commissioner for autonomous technology grants; to provide for a legislative management study; and to provide a report.
A BILL for an Act to provide appropriations to the attorney general, the department of career and technical education, the department of health and human services, and the agriculture commissioner for autonomous technology grants; to provide for a legislative management study; and to provide a report.