Currents in Contemporary Ethics Direct-to-Consumer Genetic Testing: Is it the Practice of Medicine?

National Institutes of Health, National Human Genome Research Institute, “All About the Human Genome Project,” available at <http://www.genome.gov/l0001772> (last visited March 12, 2009).

Genetics and Public Policy Center, “Genetic Testing Quality Initiative,” available at <http://www.dnapolicy.org> (last visited April 9, 2009); Javitt G. H. Hudson K. , “Federal Neglect: Regulation of Genetic Testing,” Issues in Sciences and Technology 27, no. 3 (2006): 59–66, at 59.

Genetics and Public Policy Center, “Publication Announcement: Comparison of State Laws for Direct-to-Consumer Testing,” available at <http://www.dnapolicy.org> (last visited April 9, 2009).

Langreth R. , “California Orders Stop to Gene Testing,” Forbes.Com, June 14, 2008, available at <www.forbes.com/2008/06/14/stopgene-testing-biz-healthcare> (last visited on April 9, 2009).

Genetics and Public Policy Center, “Direct-to-Consumer Genetic Testing Companies,” available at <http://www.dnapolicy.org> (last visited April 9, 2009).

Prainsack B. Reardon J. , “Misdirected Precaution,” Nature 456 (2008): 34–35.

Alliance Genetic , “Promotion of Genetic Testing Services Directly to Consumers,” available at <http://www.geneticalliance.org> (last visited April 9, 2009).

McGuire A. L. Diaz C. M. Wang T. Hilsenbeck S. G. , “Social Networkers' Attitudes toward Direct-to-Consumer Personal Genome Testing,” American Journal of Bioethics (forthcoming July 2009).

Hall M. A. McEwen J. E. Barton J. C. Walker A. P. , “Concerns in a Primary Care Population About Genetic Discrimination by Insurers,” General Medicine 7, no. 5 (2005): 311–316.

H.R. 493, Genetic Information Non-discrimination Act of 2008, available at <http://www.genome.gov/24519851> (last visited March 12, 2009).

See Alliance Genetic , supra note 7.

Federal Trade Commission, “At Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription,” available at <http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.shtm> (last visited April 9, 2009); see also U.S. National Library of Medicine, “What Do the Results of Genetic Testing Mean?” available at <http://ghr.nlrn.nih.gov/handbook/testing/interpretingresults> (last visited April 9, 2009).

See Federal Trade Commission, supra note 12; see also U.S. National Library of Medicine, supra note 12.

See U.S. National Library of Medicine, supra note 12.

23 and Me, “23 and Me Terms of Service,” available at <http://spittoon.23andme.com/terms-of-service> (last visited April 9, 2009).

23 and Me , available at <http://www.23andme.com> (last visited April 9, 2009).

Hunter D. J. Khoury M. J. Drazen J. M. , “Letting the Genome Out of the Bottle: Will We Get Our Wish?” New England Journal of Medicine 358, no. 2 (2008): 105–107.

American College of Medical Genetics, “ACMG Statement on Direct-To-Consumer Testing,” available at <http://www.geneticsinmedicine.org> (last visited April 9, 2009).

Correspondence between SACGHS and the Secretary of Health and Human Services, available at <http://oba.od.nih.gov/SACGHS/sacghs_documents.html> (last visited April 9, 2009).

See Federal Trade Commission, supra note 12.

Medical News Today, “American Medical Association Adopts New Direct-To-Consumer Policy Recommendations,” August 14, 2008, available at <http://www.medicalnewstoday.com/articles/118231.php> (last visited on April 9, 2009).

Certain web sites provide a listing of the various state laws that define the practice of medicine. See American Academy of Psychiatry and the Law, “Definition of the Practice of Medicine: A State-by-State Survey,” available at <https://www.aapl.org/state_law_prac_med.htm (last visited April 9, 2009).

For instance, the statutes regulating the practice of medicine in the States of California, Florida, Illinois, New York, and Texas contain a combination of these words.

Hurley v. People , 63 P.2d 1227, 1229–1230 (Colo. 1936); Underwood v. Scott, 23 P. 942, 943 (Kan. 1890).

Hurley , 63 P.2d at 1229.

Curley v. State , 16 So.2d 440, 440–41 (Fla. 1944).

See, e.g., Hernon v. EG Corrigan Constr. Co. , 595 N.E.2d 561, 562 (Ill. 1992).

Webster's New International Dictionary (3d ed. 1993): 622; see also Curley , supra note 27.

Nunnally A. C. , “Commercialized Genetic Testing: The Role of Corporate Biotechnology in the New Genetic Age,” Boston University Journal of Science & Technology Law 8, no. 1 (2002): 306–346, at 326.

Han J. , “The Optimal Scope of FDA Regulation of Genetic Tests: Meeting Challenges and Keeping Promises,” Harvard Journal of Law & Technology 20, no. 2 (2007): 423–441, at 434.

See Nunnally , supra note 31.

United States Government Accountability Office, Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers , July 27, 2006, available at <http://www.gao.gov> (lasted visited April 9, 2009).

See, e.g., web site of 23 and Me, Inc., available at <https://www.23andme.com/howitworks>; web site of Sciona, Inc., available at <http://www.mycelldnafitness.com/legal.aspx>; web site of deCodeme, available at <http://www.decodeme.com/faq>. (All last visited April 9, 2009).

See McQuire , supra note 8.

Cohen M. H. , “Healing at the Borderland of Medicine and Religion: Regulating Potential Abuse or Authority by Spiritual Healers,” Journal of Law and Religion 18, no. 2 (2002): 373–426, at 409.

McGuire A. L. Burke W. , “An Unwelcome Side Effect of Direct-to-Consumer Personal Genome Testing: Raiding the Medical Commons,” JAMA 300, no. 22 (2008): 2669–2671.

See 42 C.F.R. Part 493 (2008).

Report of the Secretary's Advisory Committee on Genetics, Health, and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services , April 2008, available at <http://www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdf. (last visited April 9, 2009).

Navigenics , “Terms of Services,” available at <http://www.navigenics.com/visitor/what_we_offer/our_policies/terms_conditions> (last visited April 9, 2009).

ABIM, ACP-ASIM Foundation, European Federation of Internal Medicine, “Medical Professionalism in the New Millenium: A Physician Charter,” Journal of the American College of Surgeons 196, no. 1 (2003):115–18.

See generally Bovara v. St. Francis Hosp., 700 N.E.2d 143 (Ill. App. Ct. 1998); Corbet v. McKinney, 980 S.W.2d 166 (Mo. 1998); Irvin v. Smith, 31 P.3d 934 (Kan. 2001); Kelley v. Middle Tennessee Emergency Physicians, 133 S.W.3d 587 (Tenn. 2004); Lownesbury v. Van Buren, 762 N.E.2d 354 (Ohio 2002); Raptis-Smith v. St. Joseph's Medical Ctr., 755 N.Y.S.2d 384 (N.Y. App. Div. 2003); Sterling v. Johns Hopkins Hosp., 802 A.2d 440 (Md. 2002); St. John v. Pope, 901 S.W.2d 420 (Tex. 1995); Walters v. Rinker, 520 N.E.2d 468 (Ind. 1988).

See generally Bovara, 700 N.E.2d at 143; Corbet, 980 S.W.2d at 166; Irvin , 31 P.3d at 934; Kelley, 133 S.W.3d at 587; Lownesbury, 762 N.E.2d at 354; Sterling, 802 A.2d at 440; St. John, 901 S.W.2d at 420; Walters, 520 N.E.2d at 468.

See Walters , 520 N.E.2d at 472.

Id. at 472; see also Dougherty v. Gifford, 826 S.W.2d 668, 675 (Tex. App. – Texarkana 1992, no writ).

St. John , 901 S.W.2d at 424.

Dougherty , 826 S.W.2d at 675 (concerning a pathologist); Peterson v. St. Cloud Hosp., 460 N.W.2d 635 (Minn. Ct. App. 1990) (concerning a pathologist); Phillips v. Good Samaritan Hosp., 416 N.E.2d 646 (Ohio 1979) (concerning a radiologist); Raptis-Smith, 755 N.Y.S.2d at 386 (concerning a radiologist); Walters, 520 N.E.2d at 468 (concerning a pathologist).

Grosse S. D. Khoury M. , “What is the Clinical Utility of Genetic Testing?” Genetics in Medicine 8, no. 7 (2006): 448–450, at 448.

Id., at 448.

See Report of the Secretary's Advisory Committee on Genetics, Health, and Society, supra note 41.

See McGuire , supra note 39, at 2669–2670; see also id.