Only by studying genetic information from many people can the importance of individual variants be discerned. As with other types of information in emerging medical fields, many of the problems associated with the use of genetic information arise from two time lags.
B. GINA
First, as noted above, the Privacy Rule applies only to covered entities in the health care payment chain, and not to many other entities that acquire, store, use, or disclose genetic information, such as insurers other than health insurers. It also generally does not apply to DTC genetic testing companies, including ancestry testing companies. The second limitation is that the Privacy Rule is known to contain numerous exceptions to the individual authorization requirements, which are discussed below.
Third, many observers believe that its protections are inadequate because they can only be enforced by the HHS Office for Civil Rights and do not create a private right to act on behalf of the person whose information is disclosed.79 Therefore, the nominal privacy protections afforded to genetic information that held by HIPAA-covered entities do not fully address the need to protect genetic privacy.
C. ACMG List
D. Informing At-Risk Relatives
A much-discussed court opinion has suggested that there may be a legal duty on the part of the physician to make these disclosures to the patient's relatives,83 and a guidance document from the American Society of Human Genetics states that disclosure is appropriate in some very unusual circumstances. 84 Nevertheless, both sources predate the compliance date of the 2003 HIPAA Privacy Rule, which prohibits nonconsensual disclosure of genetic information to a patient's relatives. irreparable rift between patients and their healthcare provider, prove burdensome and impractical in identifying and contacting patients' relatives, and cause harm by offering to disclose sensitive health information that relatives may not want to receive. See Office for Civil Rights, Department of Health and Human Services, FAQ: Does HIPAA permit a physician to contact a patient's family or law enforcement if the physician believes the patient may harm himself or someone else?https:// www.hhs. gov/hipaa/for-professionals/faq/2096/does-hipaa-permit-doctor-contact-patients-family-or-law-enforcement-if-doctor-believes-patient.html. The Privacy Rule allows a health care provider to disclose necessary information about a patient to law enforcement, the patient's family members, or other persons when it believes the patient poses a serious and immediate threat to itself or others.).
In 2013, the Office for Civil Rights in the Department of Health and Human Services issued the following interpretation: "Health care providers may share genetic information about an individual with providers treating family members of the individual who are seeking to identify their own genetic risks, provided the individual has not accepted a limitation on such disclosure.” Although this interpretation allows the release of sensitive information without the patient's consent, the interpretation is limited.
GENETIC INFORMATION IN DTC GENETIC TESTING
In addition, many indicated that they would retain the genetic data resulting from these samples indefinitely. The policies also varied in terms of what information was provided regarding ownership and commercialization of genetic data. The rest of the industry is largely left to self-regulate, including with regard to the quantity and quality of information they provide to consumers about their companies' genetic data practices.
110 Press Release, Future of Privacy Forum and Leading Genetic Testing Companies Announce Best Practices to Protect Privacy of Consumer Genetic Data (Future of Privacy Forum, July 31, 2018), https://fpf.org. OTHER USE AND DISCLOSURE OF GENETIC INFORMATION For individuals to maximize the health care benefits of their genetic data generated by.
OTHER USES AND DISCLOSURES OF GENETIC INFORMATION For individuals to maximize the healthcare benefits of their genetic data generated by
Although adoption of the Best Practices is voluntary, and thus lacks an enforcement mechanism, companies are encouraged to '[p]rovide public/consumer-facing commitments that are enforceable by the FTC, State Attorneys General or law enforcement authorities. others'. 113 The industry efforts embodied in the Best Practices represent a positive development and help to facilitate a dialogue about important privacy issues, but it remains to be seen whether they will be widely adopted in the diverse DTC-GT industry. It is also unclear whether companies will be willing to make disclosures that are not currently mandated under existing laws and regulations, particularly disclosures that could expose a company to potential liability.114.
A. HIPAA Public Purpose Exceptions
Any requirement for covered entities to disclose information, such as notifying public health agencies about certain infectious diseases, arises under separate provisions of federal or state law. Public exceptions to the Privacy Rule state that disclosure of PHI for such a purpose is "permissible" in the sense that covered entities may make such disclosures without violating the Privacy Rule.
B. Other Lawful Uses of Genetic Information
Federal privacy protections cover health information, including genetic information, that is collected, maintained, or used by educational institutions under the federal Education Rights and Privacy Act.136 Other laws that apply to the use of genetic information in education include individuals with on Education of Persons with Disabilities,137 Title II of the Americans with Disabilities Act (ADA),138 and Section 504 of the Rehabilitation Act.139 Although little predictive genetic information is currently used in educational settings, students' genetic information may be used (or misused) in the future. in admission, educational placement, curriculum development and discipline.140. Therefore, it is common for healthcare providers to disclose complete medical records, which often include genetic information. Guidotti, Limiting Occupational Health Screenings Under the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act, 41 AM.
Regulating the use of genetic information in insurance is extremely difficult for several reasons. California is the only state that specifically prohibits the use of genetic information to discriminate in housing.169.
GENETICS AND IDENTIFICATION
In addition to medical malpractice cases, genetic information may be relied upon by either plaintiffs or defendants in an attempt to prove or disprove causation in toxic tort and other cases involving alleged harmful exposure.165 In any personal injury case in which ' a court is asked for prospective damages the life expectancy of the plaintiff, the defendant may attempt to compel genetic testing of the plaintiff or to allow predictive genetic information into evidence.166 In such a case, already-injured plaintiffs may be forced to learn genetic information they would prefer not to know. Genetic discrimination claims involving real estate and commercial transactions are likely to increase in importance. For example, senior residential communities, mortgage companies, or other entities may seek to prevent individuals with a genetic predisposition to Alzheimer's disease from buying, renting, or acquiring real estate.167 A retirement facility may be concerned that individuals with Alzheimer's disease will undermines the development's marketing strategy to appeal to vibrant, active and healthy retirees.
Access to information in the medical record is primarily controlled by HIPAA, which as noted above has several exceptions, as well as state law in some jurisdictions. To comply with the 21stCentury Cures Act,170 NIH now automatically issues certificates of confidentiality, which prevent forced disclosure to most third parties, to all NIH-funded research involving 'identifiable, sensitive information,' specifically defined by NIH as including ``[research that involves the generation of individual-level, human genomic data from biospecimens, or the use of such data".171 Use of genetic data is also subject to anti-discrimination laws, such as GINA, the ADA, and some state laws, as well as provisions of the ACA.
A. The Debate about Reidentification
Until recently, the primary sources of identified genetic data in the US were forensic databases, which are accessible only to law enforcement. Interestingly, they state that law enforcement is specifically allowed to upload 'raw data' to identify perpetrators of sexual assault or murder. In the future, it may be possible to infer enough of an individual's facial features from his/her DNA191 to allow the person to be identified, especially in light of the increasing sophistication of photo tagging software.
These other data are more easily identifiable in the current data environment than genomic data itself.195. Part of the solution to deterring re-identification in the first place may be to adopt the proposal of the Working Group of the Precision Medicine Initiative197 that Congress enact sanctions for inappropriate re-identification or otherwise misuse of data.
B. Surreptitious Genetic Testing
A less obvious concern, which is present in both civilian and law enforcement contexts, relates to the underlying quality of the samples being analyzed. Phillips, Just a Click Away – DTC Genetics for Ancestry, Health, Love…and More: A Look at the Business and Regulatory Landscape, 8 APPL. The frequency with which surreptitious testing appears to occur should not be surprising in light of the paucity of relevant federal and state laws on the subject and the limited scope of existing laws.
Despite repeated calls from legal scholars205 and government advisory committees206 for increased oversight of surreptitious testing and stricter laws governing non-consensual collection and analysis of the genetic material of others, no comprehensive federal laws currently prohibit the practice. Instead, the US relies on a patchwork of state laws that place different restrictions on the practice depending on the purpose of the testing or the context in which it is conducted.
CONCLUSION
Although healthcare institutions have and will continue to have strong incentives to protect patient data due to the increasing emphasis on transparency and trust, once in the patient's medical record, access to genetic information can be granted to a wide range of entities under broad regulatory exemptions in under the HIPAA Privacy Policy.224 In addition, millions of people each year are forced to provide unrestricted access to their health information for various purposes, such as insurance and commercial transactions.225 To the extent that this information becomes accessible outside of health care settings (i.e., HIPAA covered entities), loses even a modicum of the protection afforded by the HIPAA Privacy Rule, creating the potential for harm or abuse by a range of downstream actors. A significant change in the ecology of genetic information is the emergence of genetic testing and interpretation of DTCs, which have so far been used by millions of people and have largely avoided regulation, except in some cases where these companies offer health-related results. The latter use necessarily requires identifiable genetic information to establish or disprove relationships.
Our research has shown that more and more genetic information is being created, analyzed, shared and stored by different individuals and entities. At the same time as genetic information flows through the sieve-like regulatory structures of the covered entities, many other entities acquire sensitive health information.
