This bill enacts the "Tennessee Genomic Security and End Organ Harvesting Act," which adds the following prohibitions:
For a health benefit plan that is offered, issued, delivered, amended, or renewed by a health insurer to take effect on or after January 1, 2026, prohibits a health insurer from knowingly providing coverage for a human organ transplant or post-transplant care if (i) the transplant operation is performed in the People's Republic of China or (ii) the human organ to be transplanted was procured by sale or donation originating in the People's Republic of China. The commissioner of health may designate additional countries with governments that fund, sponsor, or otherwise facilitate forced organ harvesting and must provide written notice to the governor when the commissioner designates an additional country. The commissioner must maintain a list of designated countries on the department's public website.
Prohibits a medical facility or research facility from using genetic sequencers, or any operational or research software used for genetic sequencing, produced in or by a nation specified in 15 CFR 791.4 ("foreign adversary"), a state-owned enterprise of a foreign adversary, a company domiciled within a foreign adversary, or a subsidiary or affiliate that is owned or controlled by a company domiciled within a foreign adversary. All genetic sequencers and operational and research software used for genetic sequencers or genetic sequencing devices prohibited under this bill, which are not permanently disabled, must be removed and replaced within 180 days after the effective date of this act with genetic sequencers and operational and research software used for genetic sequencers or genetic sequencing in compliance with this this bill. As of the date that this summary was prepared, 15 CFR 791.4 specifies the following nations as foreign adversaries: the People's Republic of China, including the Hong Kong Special Administrative Region (China); the Republic of Cuba (Cuba); the Islamic Republic of Iran (Iran); the Democratic People's Republic of Korea (North Korea); and the Russian Federation (Russia).
Restricts storage of all genetic sequencing data to the geographic location of the United States. Remote access to data storage, other than open data, from outside the United States is prohibited unless approved in writing by the commissioner of health. Medical facilities, research institutions, and other companies and entities storing genetic sequencing data, including through contracts with third-party data storage companies, must ensure the security of genetic sequencing data using reasonable encryption methods, restrictions on access, and other cybersecurity best practices.
As used in this bill, a "medical facility" means a facility for the delivery of health services that (i) receives state funds, including interagency pass through appropriations from the federal government; (ii) is registered with this state to provide healthcare services in this state; or (iii) conducts research or testing on, with, or relating to genetic sequencing or the human genome.
AUTHORITY OF ATTORNEY GENERAL
This bill authorizes the attorney general to investigate allegations of violations of this bill. Any person may notify the attorney general of a violation or potential violation. If an employee of an entity accused of a violation notifies the attorney general of a violation or a potential violation, then the employee is afforded all protections as described in present law regarding discharge for refusal to participate in or remain silent about illegal activities or for legal use of an agricultural product.
PENALTIES
On or before July 1 each year, under the penalties of perjury, this bill requires each medical facility and research institution covered under this bill to certify to the attorney general and the commissioner of health that the facility or institution is compliant with this bill. Any medical facility or research institution that violates the storage restrictions described above is subject to a fine of $10,000 for each violation, to be imposed by the commissioner of health. A violation occurs each instance an individual's genome having undergone genetic sequencing or analysis using a prohibited genetic sequencers or operational and research software is used for genetic sequencers or genetic sequencing.
This bill provides that a health benefit plan that knowingly provides coverage for an organ transplant or post-transplant care prohibited by this bill is subject to a fine of $100,000 for each violation, to be imposed by the commissioner of commerce and insurance. An entity that knowingly stores genetic sequencing data outside of the United States as prohibited in this bill is subject to a fine of $10,000 for each violation, to be imposed by the commissioner of health.
This bill provides that, if a person is a patient or research subject of an entity that is found guilty of a violation of this bill, and that person's genetic information was used in the violation, then the person is entitled to recover statutory damages of not less than $5,000 for each unique use of the person's genomic information. Additionally, if a person is a patient or research subject of an entity that is found guilty of a violation of this bill, and that person's genetic information was used in the violation, then the person is entitled to recover statutory damages of not less than $5,000 for each unique use of the person's genomic information.
ON MARCH 10, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 395, AS AMENDED.
AMENDMENT #1 makes the following revisions:
Clarifies that the definition of "medical facility" includes a facility that is licensed with this state to provide healthcare services in this state, as well as meets other criteria.
Removes the prohibition against a health insurer knowingly providing coverage for post-transplant care if (i) the transplant operation is performed in the People's Republic of China; or (ii) the human organ to be transplanted was procured by sale or donation originating in the People's Republic of China.
Adds that a medical facility or research facility is not required to investigate any individual component of genetic sequencing equipment or software to be in compliance with the bill.
Revises the provision relative to the storage of genetic sequencing data to, instead, prohibit a medical facility or research facility (i) from storing genetic sequencing data within a foreign adversary and (ii) from allowing remote access to genetic sequencing data storage within its direction or control, other than open data, to a foreign adversary, unless approved in writing by the commissioner of health.
Removes the requirement that each medical facility and research institution certify to the attorney general that the facility or institution is compliant with the bill.
Adds that, on or before July 1 each year, under the penalties of perjury, each licensed health facility covered under the bill must certify to the health facilities commission that the licensed health facility is compliant with the bill.
Adds that any licensed health facility that violates the provisions of the bill relative to genetic sequencers and related software is subject to a fine of $10,000 for each violation, to be imposed by the health facilities commission.
Removes the authority of the attorney general to investigate allegations of violations of the bill and, instead, authorizes the health facilities commission to so investigate. Any person may notify the health facilities commission of a violation or potential violation of the bill.
Requires the health facilities commission to take no further action on a complaint if the health facilities commission must obtain authorization to enter a facility from the Center for Medicare and Medicaid Services (CMS) and CMS denies the authorization to enter.
Adds that, if an employee of an entity accused of a violation notifies the health facilities commission of a violation or a potential violation, then the employee is afforded all protections as described in law relative to illegal discharge for refusal to participate in or remain silent about illegal activities or for legal use of agricultural products.
ON MARCH 10, 2025, THE SENATE ADOPTED AMENDMENT #2 AND PASSED SENATE BILL 318, AS AMENDED.
AMENDMENT #2 makes the same changes that were made by House Amendment #1.
ON MARCH 17, 2025, THE SENATE RECONSIDERED ITS ACTIONS IN PASSING SENATE BILL 318, LIFTED THE TABLING MOTION, SUBSTITUTED HOUSE BILL 395 FOR SENATE BILL 318, AND PASSED HOUSE BILL 395.
