Prohibition on certain genetic sequencers and genetic analysis technologies — Definitions

Ark. Code Ann. § 20-9-107 — under Health Facilities and Services Generally.

Ark. Code Ann. § 20-9-107

(a) As used in this section:(1) “Foreign adversary” means the same as the definition of “prohibited foreign party” under § 18-11-802;(2) “Genetic sequencer” means a device or platform used to conduct genetic analysis, resequencing, isolation, or other genetic research;(3) “Human genome” means deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) found in human cells;(4) “Medical facility” means a facility for the delivery of healthcare services that:(A) Either:(i) Receives state moneys, including interagency pass-through appropriations from the United States Government; or(ii) Is licensed, registered, or permitted in this state to provide healthcare services; and(B) Conducts research or testing on, with, or relating to genetic analysis or the human genome;(5) “Operational and research software” means computer programs used for the operation, control, analysis, or other necessary functions of genetic analysis or genetic sequencers; and(6) “Research facility” means a facility that:(A) Receives state moneys, including interagency pass-through appropriations from the United States Government; and(B) Conducts research on, with, or relating to genetic analysis or the human genome.

(1) “Foreign adversary” means the same as the definition of “prohibited foreign party” under § 18-11-802;

(2) “Genetic sequencer” means a device or platform used to conduct genetic analysis, resequencing, isolation, or other genetic research;

(3) “Human genome” means deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) found in human cells;

(4) “Medical facility” means a facility for the delivery of healthcare services that:(A) Either:(i) Receives state moneys, including interagency pass-through appropriations from the United States Government; or(ii) Is licensed, registered, or permitted in this state to provide healthcare services; and(B) Conducts research or testing on, with, or relating to genetic analysis or the human genome;

(A) Either:(i) Receives state moneys, including interagency pass-through appropriations from the United States Government; or(ii) Is licensed, registered, or permitted in this state to provide healthcare services; and

(i) Receives state moneys, including interagency pass-through appropriations from the United States Government; or

(ii) Is licensed, registered, or permitted in this state to provide healthcare services; and

(B) Conducts research or testing on, with, or relating to genetic analysis or the human genome;

(5) “Operational and research software” means computer programs used for the operation, control, analysis, or other necessary functions of genetic analysis or genetic sequencers; and

(6) “Research facility” means a facility that:(A) Receives state moneys, including interagency pass-through appropriations from the United States Government; and(B) Conducts research on, with, or relating to genetic analysis or the human genome.

(A) Receives state moneys, including interagency pass-through appropriations from the United States Government; and

(B) Conducts research on, with, or relating to genetic analysis or the human genome.

(b) Beginning on October 1, 2025, a medical facility or research facility in this state shall not put into service within this state any new or additional genetic sequencers or operational and research software used for genetic analysis produced by a foreign adversary, a state-owned enterprise of a foreign adversary, a company domiciled within a foreign adversary, or a company-owned or company-controlled subsidiary of a company domiciled within a foreign adversary for the purpose of conducting genetic analysis.

(c) A medical facility or research facility in this state shall report in writing to the Secretary of the Department of Health on all instances of ongoing usage of genetic sequencers and operational and research software used for genetic sequencers produced by a foreign adversary, a state-owned enterprise of a foreign adversary, a company domiciled within a foreign adversary, or a company-owned or company-controlled subsidiary of a company domiciled within a foreign adversary on January 1 of each year until the equipment is no longer in use.

(d) (1) A medical facility, research facility, or other company or entity shall store all genetic sequencing data outside of foreign adversary countries.(2) Remote access to data storage, other than open data, from foreign adversary countries is prohibited.(3) If a medical facility, research facility, or other company or entity stores genetic sequencing data, including through contracts with a third-party data storage company, the medical facility, research facility, or other company or entity shall ensure the security of genetic sequencing data using reasonable encryption methods, restrictions on access, and other cybersecurity best practices.

(1) A medical facility, research facility, or other company or entity shall store all genetic sequencing data outside of foreign adversary countries.

(2) Remote access to data storage, other than open data, from foreign adversary countries is prohibited.

(3) If a medical facility, research facility, or other company or entity stores genetic sequencing data, including through contracts with a third-party data storage company, the medical facility, research facility, or other company or entity shall ensure the security of genetic sequencing data using reasonable encryption methods, restrictions on access, and other cybersecurity best practices.

(e) On or before December 31 of each year, a medical facility or research facility shall certify in writing to the Attorney General and the Department of Health that the medical facility or research facility is complying with this section.

(f) (1) A person or entity determined to be in violation of this section or found guilty of a violation of this section shall be subject to a fine of ten thousand dollars ($10,000) per violation.(2) Each unique instance of an individual's genome having undergone genetic sequencing or analysis using prohibited genetic sequencers or prohibited operational and research software shall be considered a separate violation.

(1) A person or entity determined to be in violation of this section or found guilty of a violation of this section shall be subject to a fine of ten thousand dollars ($10,000) per violation.

(2) Each unique instance of an individual's genome having undergone genetic sequencing or analysis using prohibited genetic sequencers or prohibited operational and research software shall be considered a separate violation.

(g) (1) Any person may notify the Attorney General of a violation or potential violation of this section.(2) If the person notifying the Attorney General is an employee of the entity accused of a violation, the person shall be afforded all protections of a whistleblower under the Arkansas Whistle-Blower Act, § 21-1-601 et seq.(3) If the person notifying the Attorney General is a patient or research subject of an entity found guilty of a violation of this section and the person's genetic information was used in violation of this section, the entity shall also be found to have violated the Deceptive Trade Practices Act, § 4-88-101 et seq.(4) The Attorney General may investigate allegations of violations of this section.

(1) Any person may notify the Attorney General of a violation or potential violation of this section.

(2) If the person notifying the Attorney General is an employee of the entity accused of a violation, the person shall be afforded all protections of a whistleblower under the Arkansas Whistle-Blower Act, § 21-1-601 et seq.

(3) If the person notifying the Attorney General is a patient or research subject of an entity found guilty of a violation of this section and the person's genetic information was used in violation of this section, the entity shall also be found to have violated the Deceptive Trade Practices Act, § 4-88-101 et seq.

(4) The Attorney General may investigate allegations of violations of this section.