What is the scope of legal protection for genetic therapies derived from biomedical research?

The scope of legal protection for genetic therapies derived from biomedical research is determined by a variety of laws in Maryland. Federal laws, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Genetic Information Nondiscrimination Act (GINA) of 2008, provide a general framework for the security of genetic information. In the state of Maryland, the legislative body has also enacted the Maryland Genetic Privacy Act of 2008 (MGPA) to protect the privacy and confidentiality of genetic information. The MGPA guarantees the confidentiality of participants in genetic research and prohibits the transfer of genetic information from one entity to another. In addition, the MGPA also imposes restrictions on the use of the genetic information from research participants and on the disclosure of their genetic results to third parties. Furthermore, the Act also requires informed consent from research participants and their families before any genetic testing can be performed. Finally, the Genetic Technology Act of 2001 was enacted to regulate research specifically related to genetic therapies. This Act requires that research conducted with gene therapy be conducted in strict compliance with protocols approved by a scientific review board. Additionally, a Genetics Advisory Council is required to review all research protocols and any therapeutic products intended for use in humans. This legislation ensures that genetic therapies derived from biomedical research are protected and used in a responsible manner.

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What is the scope of legal protection for genetic therapies derived from biomedical research?

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