(RxWiki News) In the last decade, an explosion in gene research and subsequent genetic tests have offered new insight into genetic diseases. However, this new push also comes with concerns over protecting genetic information.
The American Heart Association has proposed guidelines focused on heart and blood vessel diseases designed as safeguards for patients against potential misuse of genetic information.
"Talk to your doctor about genetic information protection."
Euan A. Ashley, MRCP, D.Phil., chair of the policy statement writing group and assistant professor of medicine in the Cardiovascular Division and director of the Center for Inherited Cardiovascular Disease at Stanford University School of Medicine, called the potential of new technologies "incredible."
But she noted while genetic testing provides tremendous opportunity, there also is an associated challenge in ensuring responsibility with the information.
Mapping of the genome, or entire human genetic code, was completed in 2003. Information gleamed from this progress along with other genetic studies have led to genetic tests that are more accessible and cheaper, but regulations have not kept pace.
The guidelines suggest that patents should no longer be awarded to observe genes. Authors note that gene sequencing involves only observation, not intervention, so no patent should be required. This could help prevent a potential monopoly on genetic testing.
The guideline authors also urge establishment of federal regulations, such as by the U.S. Food and Drug Administration, over genetic testing to ensure quality.
A key point among their recommendation was expansion of anti-discrimination legislation. This would protect patients from genetic discrimination by disability, long-term care or life insurance providers, and ensure patients can receive genetic testing without being penalized.
The 2008 Genetic Information Nondiscrimination Act (GINA) prohibited discrimination from employers and health insurance companies, though insurance companies could still withhold coverage from those previously diagnosed with genetic conditions such as a congenital heart defect.
Affordable Care Act provisions to be enacted in 2014 will require group insurance companies to provide insurance to everyone who requests it regardless of their health status or genetic profile.
Other recommendations include establishing specialized genetic testing and counseling centers, increasing clinical research funding for genetics, and education regarding genetics for healthcare providers and patients.
“The safeguards are essential for patients in a new age of medicine. This is an unbelievable time in genetics,” Ashley said. “The pace of change has been astounding. You can imagine a world now where every patient might have their genome in the medical record, and the doctor might be able to simply look it up when prescribing medication.”
The statement was recently published in Circulation, an American Heart Association journal.