S1356

An Act concerning health data and information collected by medical device technology companies and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. a. The Legislature finds and declares that patients are entitled to all of the granular data produced by medical devices, such as cardiac devices, which are collected and warehoused by medical device manufacturers, and should have the right to personal access to the granular data and to give the granular data to the medical research institution of his or her choice.

b. An individual, or the individual's parent or guardian if the individual is a minor, may provide authorization for a medical device technology company to provide personal access to the individual's health data and information collected by the company to the individual and to share the health data and information to the Department of Health to be shared with medical and academic research agencies and institutions as determined by the Commissioner of Health, provided that, when applicable, such authorization is obtained, and such data and information is de-identified and shared, in a manner consistent with the provisions of the federal “Health Insurance Portability and Accountability Act of 1996,” Pub.L.104-191 and all applicable State and federal laws concerning the collection, sharing, and storage of health information, and any regulations adopted pursuant to those federal and State laws. A medical device technology company shall request such authorization as a part of the initial consent form prior to an individual receiving a medical device technology.

b. A medical device technology company shall provide electronic access to any health data and information collected from an individual to the individual and, if the individual is a minor, the individual's parent or guardian. Such access shall allow the individual, parent, or guardian to download the health data and information and, when applicable, shall be provided in a manner in compliance with all State and federal privacy laws, including the federal "Health Insurance Portability and Accountability Act of 1996," Pub.L.104-191, and related regulations.

c. As used in this section:

"Medical device technology" means a technology involving any medical equipment or product, other than a pharmaceutical product, that has therapeutic value, diagnostic value, or both, and is regulated by the federal Food and Drug Administration.

"Medical device technology company" means a person or organization, whose headquarters or base of operations is located in New Jersey, who is engaged in the research, development, production, or provision of medical device technology for the purpose of developing or providing products or processes for specific commercial, diagnostic, treatment, or public purposes.

2. This act shall take effect immediately.

STATEMENT

This bill expressly permits an individual to provide authorization for a medical device technology company to provide personal access to the individual's health data and information collected by the company to the individual and to share the health data and information to the Department of Health to be further shared with medical and academic research agencies and institutions. The bill requires that, when applicable, the authorization is obtained, and the data and information is de-identified and shared, in a manner consistent with the provisions of all applicable State and federal laws concerning the collection, sharing, and storage of health information, and any regulations adopted pursuant to those federal and State laws. The bill requires each medical device technology company to provide electronic access to any health data and information collected from an individual to the individual, and such access should allow the individual to download the health data and information. If the individual is a minor, the bill provides that the parent or guardian can access, and authorize the sharing of, health data and information collected by a medical device technology company pursuant to the provisions of the bill.

The bill defines "medical device technology" to mean a technology involving any medical equipment or product, other than a pharmaceutical product, that has therapeutic value, diagnostic value, or both, and is regulated by the federal Food and Drug Administration. The bill defines a "medical device technology company" to mean a person or organization, whose headquarters or base of operations is located in New Jersey, who is engaged in the research, development, production, or provision of medical device technology for the purpose of developing or providing products or processes for specific commercial, diagnostic, treatment or public purposes. The bill finds and declares that patients are entitled to all of the granular data produced by medical devices, such as cardiac devices, which are collected and warehoused by medical device manufacturers, and should have the right to personal access to the granular data and to give the granular data to the medical research institution of his or her choice.