Introduction to Genetics and the Law

2021 ◽  
Author(s):  
Maxwell Mehlman ◽  
Mette Hartlev ◽  
Sonia Suter
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Genetic Testing ◽  
Informed Consent ◽  
Genomic Analysis ◽  
The United States ◽  
Legal Issues ◽  
Legal Doctrine ◽  
The Law ◽  
Material Information

This chapter provides an overview of the relationship between genetics and the law. Advances in genetics and genomics have created both hopes and concerns and raise a number of legal issues in both the United States and Europe. To understand the legal issues in genetics, it is helpful to have some understanding of the different types of genetic analysis that can be used and for which purposes. In virtually all these contexts, the doctrine of informed consent is important. While the law in the United States and Europe does not generally require non-directiveness, the legal doctrine of informed consent applies in all jurisdictions, imposing on physicians and genetic counselors the legal obligation to disclose material information that could influence a patient's decisions about genetic testing. The other ethical and legal issues that arise with genetic or genomic analysis differ depending on the purpose, context, and technology used. These legal issues concern the methods of regulating genetic tests offered in the clinical setting and through the “direct-to-consumer” online genetic testing industry; genetic discrimination; the scope of privacy protections of genetic information; and the regulation of human gene therapy, gene therapy research, and germline modifications.

Issues to Consider Before Asserting A Software Patent

2020 ◽  
Vol 21 (3) ◽  
pp. 205-212
Author(s):  
Michael C. Greenbaum ◽  
S. Gregory Herrman
Keyword(s):  
United States ◽  
The United States ◽  
Careful Consideration ◽  
Legal Issues ◽  
Patent Office ◽  
Patent Owner ◽  
Software Patents ◽  
The Law ◽  
Software Patent

Software patents have garnered a lot of attention in recent years due, at least in part, to the proliferation of software-enabled devices, such as smartphones and tablets, and the use of software to control a range of devices from automobiles to kitchen appliances. Enforcement of software patents involves unique legal issues that should be considered before asserting a patent against an accused infringer. A primary issue to consider is whether the patent claims are still patent-eligible under recent changes in the law. Also, certain types of software patents are vulnerable to attack in U.S. Patent Office proceedings, but these proceedings are not available unless the patent owner takes step to provoke them. In addition, software inventions are often implemented as method patents, which have unique requirements and restrictions that should be considered. For example, steps of a method patent must all be performed by an accused infringer in the United States and must all be performed by the same entity (or under the direction or control of that entity). Where a software invention is not implemented as a method patent, pre-suit damages may not be available unless the patentee's own products are properly marked with the patent number, and software has very different requirements for marking than more tangible products. A careful consideration of each of these issues is essential before moving forward with a lawsuit.

Genetics and the Law

2021 ◽  
Author(s):  
Maxwell Mehlman ◽  
Mette Hartlev ◽  
Sonia Suter
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Informed Consent ◽  
Newborn Screening ◽  
Screening Program ◽  
The United States ◽  
Parental Consent ◽  
Genetic Sequencing ◽  
Opt Out ◽  
Genetic Technologies

This chapter explores the similarities and differences in the legal approaches in the United States and Europe to genetic issues. Both the United States and Europe value informed consent and autonomy in this context. As a result, individuals must give informed consent to genetic testing and can decide to opt out of being informed by their health professionals about genetic sequencing results, including results that are clinically relevant. All states in the United States conduct newborn screening using DNA samples, and most do so without parental consent. In Europe, most countries have a newborn screening program, and most of these require parental consent. The chapter also looks at the legal approaches to genetic discrimination, as well as human gene therapy and gene therapy research. As genetic technologies continue to evolve, the United States and Europe will likely continue to face similar ethical and legal issues regarding the regulation of that genetic technology. However, their approaches will likely overlap in some ways and diverge in others, reflecting differences in the legal structures and cultures of each jurisdiction.

Personnel Standards and Quality Assurance Practices of Biochemical Genetic Testing Laboratories in the United States

2003 ◽  
Vol 127 (1) ◽  
pp. 71-76
Author(s):  
Margaret M. McGovern ◽  
Marta Benach ◽  
Sylvan Wallenstein ◽  
Joe Boone ◽  
Ira M. Lubin
Keyword(s):  
United States ◽  
Quality Assurance ◽  
Genetic Testing ◽  
Informed Consent ◽  
The United States ◽  
Laboratory Practice ◽  
Reporting Practices ◽  
Testing Laboratories ◽  
Biochemical Genetic ◽  
Practice Committee

Abstract Context.—It has been suggested that specific regulation of laboratories performing genetic testing may be needed to ensure standards and quality assurance, and to safeguard the rights of patients with regard to confidentiality and providing informed consent. Previously, a comprehensive analysis of current practices of molecular genetic testing laboratories was conducted, the results of which have assisted in the assessment of the need for regulation and its impact on access to testing. However, a study designed to determine clinical laboratory practices with regard to biochemical genetic testing has not been carried out. Objective.—To collect and analyze data regarding availability of clinical biochemical genetic testing, personnel standards, and laboratory quality assurance practices. Design.—A mail survey of biochemical genetic testing laboratory directors and assignment of a quality assurance score based on responses to genetic testing process items. Setting.—Hospital-based, independent, and research-based biochemical genetic testing laboratories in the United States. Participants.—Directors of biochemical genetic testing laboratories (n = 133; response rate 68.5%). Main Outcome Measure.—Laboratory process quality assurance score based on the standards defined by the American College of Medical Genetics Laboratory Practice Committee. Results.—Personnel qualifications varied, although all directors had doctoral degrees. The mean quality assurance score was 77% (range 28%–100%). Higher scores were associated with the following variables: test director having an MD degree versus PhD degree (P = .002), director board certification in biochemical genetics (P = .002), research and hospital laboratory versus independent laboratory setting (P < .001), and participation in a proficiency testing program (P = .03). Twelve percent of participants had a confidentiality policy, and 19% required informed consent before testing. Conclusion.—The finding that a number of laboratories had quality assurance scores that may reflect suboptimal laboratory practices, particularly with regard to reporting practices, suggests that personnel qualification and laboratory practice standards may be in need of improvement to ensure quality in clinical biochemical genetic testing laboratories, as well as the appropriate clinical use of the test results.

Fragments of the American Dream: Immigration, Race, and Medical Care in the Segregated South, 1929

Public Voices ◽  
2016 ◽  
Vol 13 (2) ◽  
pp. 1
Author(s):  
John R Phillips
Keyword(s):  
United States ◽  
American Dream ◽  
Black Population ◽  
The United States ◽  
Single Woman ◽  
Future Research ◽  
Legal Doctrine ◽  
Quarter Century ◽  
History Of ◽  
Sunflower County

The cover photograph for this issue of Public Voices was taken sometime in the summer of 1929 (probably June) somewhere in Sunflower County, Mississippi. Very probably the photo was taken in Indianola but, perhaps, it was Ruleville. It is one of three such photos, one of which does have the annotation on the reverse “Ruleville Midwives Club 1929.” The young woman wearing a tie in this and in one of the other photos was Ann Reid Brown, R.N., then a single woman having only arrived in the United States from Scotland a few years before, in 1923. Full disclosure: This commentary on the photo combines professional research interests in public administration and public policy with personal interests—family interests—for that young nurse later married and became the author’s mother. From the scholarly perspective, such photographs have been seen as “instrumental in establishing midwives’ credentials and cultural identity at a key transitional moment in the history of the midwife and of public health” (Keith, Brennan, & Reynolds 2012). There is also deep irony if we see these photographs as being a fragment of the American dream, of a recent immigrant’s hope for and success at achieving that dream; but that fragment of the vision is understood quite differently when we see that she began a hopeful career working with a Black population forcibly segregated by law under the incongruously named “separate but equal” legal doctrine. That doctrine, derived from the United States Supreme Court’s 1896 decision, Plessy v. Ferguson, would remain the foundation for legally enforced segregation throughout the South for another quarter century. The options open to the young, white, immigrant nurse were almost entirely closed off for the population with which she then worked. The remaining parts of this overview are meant to provide the following: (1) some biographical information on the nurse; (2) a description, in so far as we know it, of why she was in Mississippi; and (3) some indication of areas for future research on this and related topics.

Denial of Health Care and Informed Consent in English and American Law

1992 ◽  
Vol 18 (1-2) ◽  
pp. 37-71
Author(s):  
Frances H. Miller
Keyword(s):  
United States ◽  
Health Care ◽  
Informed Consent ◽  
The United States ◽  
Health Care Rationing ◽  
Legal Obligation ◽  
The United Kingdom ◽  
American Law ◽  
Care Rationing ◽  
Increased Pressure

Health care rationing has gained greater visibility in the United States and the United Kingdom, for quite different reasons. As patients in both countries become more aware that potentially beneficial medical services can be denied them on economic — as opposed to purely medical — grounds, they are beginning to seek help from the judiciary. This Article contends that as rationing becomes more explicit, the doctrine of informed consent will come under increased pressure. The Article suggests that courts and legislatures consider imposing a legal obligation on physicians to inform their patients when potentially effective treatment is to be withheld for economic or other non-clinical reasons.

Fun v. Pulgar and Albergrin

2019 ◽  
Vol 180 ◽  
pp. 722-727
Keyword(s):  
United States ◽  
The United States ◽  
Vienna Convention ◽  
Diplomatic Relations ◽  
Commercial Activity ◽  
Domestic Servant ◽  
The Law ◽  
Diplomatic Immunity

Diplomatic relations — Diplomatic agents — Immunity from jurisdiction — Vienna Convention on Diplomatic Relations, 1961 — Article 31(1)(c) — Action by domestic servant alleging that she had been trafficked and forced to work by former employers — Certification of diplomatic status of former employers — Whether diplomatic immunity continuing despite subsequent termination of diplomatic status — Whether commercial activity exception applicable to hiring of domestic servant — Whether subsequent attempts at service defective — Whether Court lacking jurisdiction — The law of the United States

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