Telehealth Physician Oversight over Direct to Consumer Testing: Doctors Working with Patients Towards Patient Empowerment

Abstract

Objective: Patient empowerment has increased the demand for direct to consumer (DTC) laboratory testing. Multiple professional societies and advocacy groups have raised concerns over how DTC laboratory testing is being offered to consumers without proper physician oversight. Physician telehealth services can properly oversee DTC laboratory testing in a safe and medically sound manner. Materials: Using telehealth protocols and standards established by professional health organizations and state regulators, physician telehealth oversight in DTC laboratory test ordering can be effective to increase patient access to healthcare services. Results: With proper physician oversight in test interpretation, post-test counseling, and information collaboration, DTC laboratory testing can remain a reliable and convenient option for consumers. Working within the channel of distribution of most DTC laboratory testing, physician telehealth services can properly oversee DTC laboratory testing in a safe and medically sound manner to ensure that proper test interpretation, counseling, and information collaboration are achieved. Conclusions: Physician telehealth services can properly oversee DTC laboratory testing to ensure that proper test interpretation, counseling, and information collaboration are achieved.

Introduction

Medical care is becoming increasingly complex, and improvements in health technology have led to a multitude of available treatments. The treatment [patients] choose should reflect the personal values and lifestyles of the patient and their family.¹

—Congressman Pete Stark (CA)

When it comes to healthcare, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.²

—Secretary of Health and Human Services Kathleen Sebelius

With a click of a mouse, we access, read, and evaluate all types of online health information—from anterior cruciate sprains³ to Zoloft^® (Pfizer) dosages.⁴ On television, we watch commercials on Cialis^® (manufactured by Eli Lilly and Company to treat erectile dysfunction).⁵ Dr. Oz (produced in affiliation with ZoCo 1, LLC) tells us the latest fads in treatment and medical care.⁶ From our iPhone^® (Apple, Inc.), Android™ (Google, Inc.), or BlackBerry^® (Research in Motion), we download “apps” to track asthma attacks and insulin injections.^7,8 New tools and information are introduced into consumers' daily lives as part of a movement towards patient empowerment (i.e., a demand for more control over a consumer's own health directives).⁹ “Patient empowerment in the healthcare context means to promote autonomous self-regulation so that the individual's potential for health and wellness is maximi[z]ed. Patient empowerment begins with information and education and includes seeking out information about one's own illness or condition, and actively participating in treatment decisions.”¹⁰ Patient empowerment is based upon a belief that an engaged, activated patient will achieve better outcomes.¹¹ One clear example where patient empowerment has had a clear impact is direct to consumer (DTC) laboratory testing (i.e., consumer-directed laboratory tests).

DTC

The Food and Drug Administration (FDA) originally described the term “direct to consumer” as a method of advertising whereby healthcare companies communicate directly to consumers about their products¹² and has offered additional subsequent consumer updates.^13,14 The advertising can come from several different channels (e.g., television, radio, online, telephone). The desired result, however, is the same—to sell more products.

More recently, the FDA has noted the growth in laboratory testing being offered directly to consumers and held public hearings and panels in July 2010¹⁵ and March 2011.¹⁶ The tests being offered directly to consumers have caused a new definition of the term DTC as it applies specifically to laboratory testing—namely, these are tests that are offered online or over the phone, so that a consumer can request the test at his or her own initiative, rather than needing to go to the doctor to ask for the test. This process is distinct from the FDA's “over the counter” tests, which can be purchased in retail settings and used by a consumer at home to get immediate results, such as glucose strips and home pregnancy kits.¹⁷ It is also distinct from “direct access” designation, in which certain state laws permit labs to make available to consumers a select number of test services that can be ordered without an authorized order from a physician (see, for example, New York Public Health Law §576-b¹⁸).

A recent report from CNN describes the typical DTC laboratory testing as follows:

Patients needing lab work can go to [a] website and click on the big yellow box in the middle of the page. From there they choose the tests their doctor says they need, give the doctor's fax number, pay with a credit card and print out the order. They then take the order to any [national diagnostic lab] location in 47 states and have the work done. Results are sent securely to the patient and the doctor, often within 24 hours.¹⁹

Indeed, the U.S. Department of Health and Human Services has reinforced the need for patients to receive laboratory testing by introducing proposed new rules designed to expand the rights of patients to access their health information and laboratory test results through the use of health information technology.²

DTC Benefits and Concerns

DTC laboratory testing clearly offers consumers several benefits: consumer control over their healthcare, early diagnosis, cost-efficiency outside of third-party payor arrangements, time saving costs, convenience, and better accessibility.^2,20
–22

Approximately 45 million people in the U.S. have no insurance coverage. DTC laboratory testing offers a relatively inexpensive way for them to acquire basic laboratory testing without having to also pay for a physician's office visit. Secondly, the baby boom generation is starting to retire and they are not only very large in numbers, but they also have shown a propensity toward an interest in their own healthcare.²³

Despite these benefits, however, DTC laboratory testing raises several concerns. Recently, for example, concerns have been raised on whether genetic testing should be offered through DTC channels.^16,24
–26 (The present article, however, will focus on how to implement standards and procedures to make DTC laboratory testing more effective and safer.) First, many companies offering DTC laboratory testing, especially those offered through the Internet, advertise that they require no physician oversight, leading consumers to interpret test values on their own. As stated by the College of American Pathologists, “[w]hile direct-to-consumer testing has the potential to empower patients in the management of their own health, it is no different than testing ordered by a licensed provider in that it poses a number of risks to the patient and public safety. Patients deserve to be gatekeepers of their health information, but they also may need a medical professional to interpret the test results and recommend next steps….”²⁷ Moreover, the American Medical Association (AMA) House of Delegates has stated that laboratory test ordering and interpretation of test results should be solely reserved for licensed physicians.²⁸ Dr. J. Edward Hill, former President of the AMA, cautioned consumers on the increasing use of DTC laboratory testing without physician oversight: “[t]rying to interpret lab tests is a very complex and very specialized thing and requires knowledge far beyond the usual layperson's ability…It's unfathomable that people are going to order tests that take years of medical training to understand.”²⁰ Second, without proper physician oversight, DTC laboratory testing is frequently offered to consumers without appropriate follow-up and post-testing counseling.^20,21 In Alaska,²⁹ Colorado,³⁰ Illinois,³¹ and Nevada,³² for example, post-test counseling is required for a patient discovered with a sexually transmitted disease through testing. Without proper post-test counseling, consumers who receive DTC laboratory testing are deprived of essential information on the prevention of infection transmission and treatment alternatives. Finally, because most DTC laboratory testing is provided outside the primary care physician relationship, consumers often times never forward resulting test values to their primary care physician—sometimes test values even get lost or misplaced by the consumer.^20,21 Test values from DTC laboratory tests, which are not routed back to the consumer's primary care physician (or into a personal health record repository), lose their utility because such values are never taken into account when designing the right treatment program for a consumer. (For personal health record repositories, see Intuit Health³³ and Microsoft HealthVault³⁴.) A consumer who never shows a primary care physician his or her hemoglobin A1c value from a DTC laboratory test will risk never being properly diagnosed with diabetes.

DTC—Physician Oversight

Prohibiting DTC laboratory testing altogether curtails the laudable goals of patient empowerment.^19

–22 As discussed above, however, the lack of proper physician oversight in test interpretation, post-test counseling, and information collaboration raises concerns over how DTC laboratory testing is being offered to consumers. DTC laboratory testing can remain a reliable and convenient option for consumers by implementing proper physician oversight measures. By using established telehealth techniques, physicians can properly oversee DTC laboratory testing in a safe and medically sound manner to ensure that proper test interpretation, counseling, and information collaboration is achieved. (For examples where telehealth has been used in physician oversight of DTC laboratory testing, see resource pages on diabetes³⁵ and colon cancer³⁶ testing offered on the Medivo.com Web site.)

Statutory Requirements Around Physician Oversight in Lab Ordering

Like traditional laboratory testing, DTC laboratory testing involves specimen collection and consequent specimen analysis in a laboratory setting (outside of federally “waived” home test kits where testing can be performed and results obtained immediately by the consumer at home [for a list of over the counter federally “waived” tests, see the U.S. Food and Drug Administration Web site³⁷]). The Centers for Medicare & Medicaid Services regulates all laboratory testing (except research) performed on humans in the United States under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).³⁸ CLIA regulations provide that a laboratory must have a written or electronic request from an authorized person in order to test a specimen.³⁹ State laws govern who the “authorized person” can be. For a majority of states, an “authorized person” is limited to designated professional individuals (not the consumer himself), including a physician licensed within such state.⁴⁰ For example, in New Hampshire, a laboratory can test specimens “only at the written or electronic request of a physician, dentist, chiropractor, court of law or any other person authorized by state statute to order and receive laboratory tests.”⁴¹ Accordingly, physician oversight in the ordering of DTC laboratory tests is necessary in order to comply with state and federal laws.

Telehealth

Most DTC laboratory testing is offered to consumers through the Internet or telephone.^19
–21 Indeed, the Internet has become ubiquitous as a channel for information exchange and consumer empowerment. According to one survey conducted by the Pew Internet & American Life Project, 8 out of 10 Internet users have looked online for health information (equivalent to 95 million Americans), and 51% of Americans using the Internet have searched online for information on medical treatments or procedures.⁴² As a result, in order to safely and efficiently deliver DTC laboratory testing, physician oversight should be provided through established physician telehealth models. Telehealth standards have already been firmly established by professional organizations, medical organizations, and state regulators—applying such standards in physician oversight to DTC laboratory testing ensures consumer safety and security will be preserved without detracting from the ease and accessibility that DTC laboratory testing provides.

Telehealth Standards

Telehealth is the use of communication equipment to link healthcare practitioners and patients in different locations.⁴³ Such communication can encompass both synchronous (e.g., transmission of information at exactly the same period) and asynchronous (e.g., “store and forward” or transmission of information in one direction in time) transmission of information.⁴⁴ The American Telemedicine Association (ATA), the Federation of State Medical Boards (FSMB), and the AMA have all promulgated rigorous standards on the practice of telehealth. The ATA provides that the practice of telehealth requires adherence to the following: (1) administrative safeguards (e.g., human resource management, privacy and confidentiality, credentialing, documentation, network security, consent to treatment, licensure); (2) clinical standards (e.g., professional discipline standards); and (3) technical standards (e.g., equipment, technical safety, redundancy).⁴⁴ In addition, the FSMB provides that the practice of telehealth involving Internet usage requires adherence to the following: (1) adherence to core professional and ethical standards involving candor, privacy, integrity, informed consent, and accountability; (2) maintaining an appropriate physician–patient relationship; and (3) adherence to other guidelines.⁴⁵ The AMA has also prescribed guidelines surrounding telehealth, including taking prudent and reasonable precautions in implementing technology to protect confidentiality, privacy, data integrity, and adherence to state licensure laws (see, for example, the resolution on telemedicine and medical licensure⁴⁶ and the cited relevant AMA health policies).⁴⁷ Finally, individual states have enacted statutes and regulations setting forth practice standards in telehealth.^48
–50 By adhering to these standards, guidelines, and statutes in the telehealth setting, physicians can provide the proper medical oversight in DTC laboratory testing. Pertinent patient information (e.g., age, gender, state of residence, etc.) can be securely transmitted using telehealth communication to physicians licensed in the patient's state of residency. Thereafter, physicians can assess and determine whether laboratory testing is medically necessary within best practice protocols and if so electronically issue corresponding approved laboratory requisitions for laboratory testing.

Informed Consent

Because DTC laboratory testing in telehealth settings raises special issues relating to security, privacy, record retention, and disclosures, a physician overseeing DTC laboratory testing should obtain the informed consent from a consumer prior to testing and specimen analysis. The ATA has set forth a model form for informed consent in telehealth settings.⁵¹ This ATA model sets forth required disclosures on expected benefits, possible risks, and certain rights with respect to the sought procedure. Furthermore, the AMA has set forth guidelines and policies on how to obtain informed consent from patients, including disclosing (1) the nature and purpose of the procedure, (2) the risks and benefits of the procedure, and (3) the risks and benefits of possible alternative procedures (examples include the AMA Policy E-8.08 [Informed Consent] and AMA House of Delegates Resolution H-140.989 [Informed Consent and Decision-Making in Healthcare]).⁵² Finally, individual states have also set forth specific statutory requirements for informed consent in telehealth settings.^53
–55 Such requirements include disclosures designed to ensure that the patient is adequately informed and apprised of the potential risks. By applying developed models and standards to DTC laboratory testing and by following applicable guidelines and statutes, consumers receiving DTC laboratory testing can be provided with essential information concerning informed consent as it applies to their DTC laboratory test.

Counseling

As stated above, interpretation of test values is very complex. As a result, physician oversight in DTC laboratory testing is critical for proper explanation of test results to consumers. Once laboratory test results are finalized, they should be properly evaluated against reference ranges of “normal,” “abnormal,” or “critical” values as established by laboratories and medical practice protocols.⁵⁶ Protocols within DTC laboratory testing should clearly establish who receives the test results, the form of communication, and the timing of communication.⁵⁷ Appropriate post-test counseling should be provided based upon the type of test and the results of such test. For example, in at least 14 states (for example, Alabama,⁵⁸ Alaska,⁵⁹ and Colorado),⁶⁰ post-test counseling is required for any patient tested positive for a sexually transmitted disease. Such counseling, which can easily be provided through telehealth services, includes instructions on the appropriate measures to take in order to prevent the spread of infection, the kinds of treatment available, and possible duties to warn third parties of infection. Thus, with proper physician oversight in DTC laboratory testing, appropriate post-testing counseling can be provided to consumers pursuant to established medical protocols and statutory requirements.

Information Collaboration

Since its passage in 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act has promoted the use and exchange of health information to improve healthcare quality, reduce medical errors and health disparities, advance the delivery of patient-centered medical care, improve coordination of care, and promote early detection, prevention, and management of chronic diseases.⁶¹ DTC laboratory testing should adhere to the stated goals of HITECH. Test results from DTC laboratory testing should be delivered to the patient's healthcare provider for further collaboration and review. Test results misplaced or lost by the patient can never be utilized or considered when diagnosing a condition or designing a method to treat it—this undermines the true value DTC laboratory testing can have on improving overall patient care. Using telehealth technology, DTC laboratory test values can easily be securely delivered to other healthcare providers. Moreover, telehealth technology can deliver DTC laboratory test values to personal health record repositories (e.g., Intuit Health or Microsoft HealthVault) controlled by the patient, thus allowing the patient to share such information with his or her healthcare provider at a later point in time. Such measures are consistent with the federal government's initiatives in developing a Health Information Exchange to “automate the transfer of health-related information that is typically stored in multiple organizations, while maintaining the context and integrity of the information being exchanged.”⁶²

A Comparison Standard: DTC Diagnostic Imaging Tests

The issues and concerns with respect to DTC laboratory testing are similar to those surrounding DTC diagnostic imaging tests (i.e., test interpretation, counseling, and information collaboration). As stated by the AMA in its Report of the Council on Ethical and Judicial Affairs on DTC imaging testing, “[a]ll encounters between patients and physicians need not stem from symptoms of a possible medical illness or be related to therapeutic interventions. Indeed, there has been considerable emphasis on preventive care, as physicians can play an important role in assisting patients to maintain good health…[I]t has been argued that patients should be permitted to access and pay for such tests without a referral because the risk of physical harm caused by the test is minimal.”⁶³ As a result, the AMA has been careful not to impose unnecessary restrictions on access to DTC imaging testing—rather, the AMA has set forth clear guidelines to ensure that DTC imaging testing remains safe and medically sound with proper physician oversight. Opinion 8.045 [Direct-to-Consumer Diagnostic Imaging Tests] of the AMA Code of Medical Ethics provides the following guidelines with respect to DTC imaging testing:

Performance of a diagnostic imaging test at the request of an individual is justifiable only if, in the judgment of the physician, the potential benefits of the service outweigh the risks.

Once a physician agrees to perform the test, a patient–physician relationship is established with all the obligations such a relationship entails…. In the absence of a referring physician who orders the test, the testing physician assumes responsibility for relevant clinical evaluation, as well as pre-test and post-test counseling concerning the test, its results, and indicated follow-up. Post-test counseling may also be accomplished through referral to an appropriate physician who accepts the patient.

In obtaining the patient's informed consent (see Opinion 8.08, “Informed Consent”), the testing physician should discuss, in a manner the patient can understand, the usual elements of informed consent as well as:

a. the inaccuracies inherent in the proposed test

b. the possibility of inconclusive results

c. false-positives or false-negatives, and

d. circumstances that may require further assessment and additional costs.

Physicians who hold financial interests in imaging facilities must not place those interests above the welfare of their patients, as stated in Opinions 8.03, “Conflicts of Interest: Guidelines” and 8.032, “Conflicts of Interest: Health Faci-lity Ownership by a Physician.” Moreover, physicians who advertise diagnostic imaging services should ensure that advertisements are truthful and not misleading or deceptive. (I, II, V, VIII).⁶⁴

Consequently, similar to DTC imaging testing, DTC laboratory testing can be safely and securely delivered using proper physician oversight. With physician oversight in lab test authorization, result interpretation, counseling, and informed disclosures, DTC laboratory testing can be delivered without detracting from any of its benefits. Physicians can provide such oversight within medically and legally established telehealth standards that are consistent with the delivery of most DTC laboratory testing today (e.g., technology-enabled channels, such as the Internet and telephone). With proper physician oversight, DTC laboratory testing can provide consumers with an invaluable tool to supplement their overall care with their healthcare providers.

Footnotes

Acknowledgments

I would like to thank Matthew Palatnik for his efforts in assisting on this article.

Disclosure Statement

R.C. is currently General Counsel and Chief Compliance Officer of Medivo Inc., a company that designs and implements programs and tools focused on saving lives through faster and easier access to quality healthcare.

References

Stark

. Introduction of the Patient Empowerment Act of 1999. Congressional Record, 160:E742 April 22, 1999. http://stark.house.gov/index.php?option=com_content&view=article&id=1954:introduction-of-the-patient-empowerment-act-of-1999&catid=78. 2012 April 1.

U.S. Health and Human Services. Secretary Sebelius Spotlights New Efforts to Empower Patients to Increase Secure Access to Health Information [press release] September 12, 2011. www.hhs.gov/news/press/2011pres/09/20110912a.html. 2012 April 1.

WebMD. Anterior Cruciate Ligament Injuries. www.webmd.com/a-to-z-guides/anterior-cruciate-ligament-acl-injuries-topic-overview. 2012 April 1.

WebMD. Zoloft Oral. www.webmd.com/drugs/mono-8095-SERTRALINE+-+ORAL.aspx?drugid=35&drugname=Zoloft+Oral&source=2. 2012 April 1.

Eli

Lilly

. Company. Cialis. http://www.cialis.com/Pages/home.aspx. 2012 April 1.

Dr. Oz. www.doctoroz.com/. 2012 April 1.

Carter

. Smartphone Apps Keep Health at Your Fingertips, from Fitness to First Aid. February 24, 2011. http://yourlife.usatoday.com/health/story/2011/02/Smartphone-apps-keep-health-at-your-fingertips-from-fitness-to-first-aid/44130448/1. 2012 April 1.

Shulman

. 5 Great Health Applications for Your iPhone. U.S. News and World Reports, July 29, 2008. http://health.usnews.com/health-news/family-health/articles/2008/07/29/5-great-health-applications-for-your-iphone. 2012 April 1.

Salmon

, Hall

. Patient empowerment or the Emperor's new clothes. J R Soc Med, 2004; 97:53–56. www.ncbi.nlm.nih.gov/pmc/articles/PMC1079288/. 2012 April 1.

10.

Lau

. Patient empowerment—A patient-centred approach to improve care. Hong Kong Med J, 2002; 8:372–374. www.hkmj.org/article_pdfs/hkm0210p372.pdf. 2012 April 1.

11.

Sinsky

. Leveraging Health Information Technology for Patient Empowerment. Presentation before the Agency for Healthcare Research and Quality's National Resource Center for Health IT, September 4, 2010. http://healthit.ahrq.gov/images/apr10patientempowerment/Patient%20Empowerment%20508/800x600/slide1.html. 2012 April 1.

12.

U.S. Department of Health and Human Services. Guidance for Industry Consumer-Directed Broadcast Advertisements. August 1999. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070065.pdf. 2012 April 1.

13.

U.S. Food and Drug Administration. Keeping Watch Over Direct-to-Consumer Ads. May 2010. www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107180.pdf. 2012 April 1.

14.

Center for Device and Radiological Health Device Regulation and Guidance, U.S. Food and Drug Administration. Consumer-Directed Broadcast Advertising of Restricted Devices, Draft Guidance—Issued 2/10/04. February 10, 2004. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071359.pdf. 2012 April 1.

15.

U.S. Food and Drug Administration. FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs) July 19–20, 2010. www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm#registration. 2012 April 1.

16.

U.S. Food and Drug Administration. Molecular and Clinical Genetics Panel Meeting. March 8–9, 2011. www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/ucm245447.htm. 2012 April 1.

17.

U.S. Food and Drug Administration In Vitro Diagnostics. How You Can Know If FDA Regulates an Over-The-Counter Test. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125666.htm. 2012 April 1.

18.

New York State Public Health Law §576-b Performance of Certain Clinical Laboratory Services upon Request. http://public.leginfo.state.ny.us/LAWSSEAF.cgi?QUERYTYPE=LAWS+&QUERYDATA=$$PBH576-B$$@TXPBH0576-B+&LIST=LAW+&BROWSER=BROWSER+&TOKEN=57627159+&TARGET=VIEW. 2012 April 1.

19.

Kavanagh

. Doctors Slash Patients' Lab-Test Costs. CNN, February 3, 2011. www.cnn.com/2010/HEALTH/12/08/low.cost.lab.tests/. 2012 April 1.

20.

Tarkan

. Blood-Test Labs Bypass Doctors, Spurring Debate. The New York Times, March 12, 2002. http://query.nytimes.com/gst/fullpage.html?res=9503EED91739F931A25750C0A9649C8B63. 2012 April 1.

21.

Wilde Mathews

. Worried About Cholesterol? Order Your Own Tests. Wall Street Journal, January 11, 2011. http://online.wsj.com/article/SB10001424052748704458204576073913850150324.html. 2012 April 1.

22.

Centers for Medicare and Medicaid Services. Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations. www.cms.gov/CLIA/Downloads/directaccesstesting.pdf. 2012 April 1.

23.

Terry

. Direct-to-Consumer Testing and Its Impact on the Lab Market. Washington G-2 Reports, January 24, 2008. www.g2reports.com/issues/advisory/advisory/mark_terry/235-1.html. 2012 April 1.

24.

U.S. Government Accountability Office. Nutrigenic Testing—Tests Purchased from Four Web Sites Mislead Consumers—Statement by Gregory Kutz. July 27, 2006. www.gao.gov/new.items/d06977t.pdf. 2012 April 1.

25.

26.

U.S. Committee on Energy and Commerce. Hearing on Direct-to-Consumer Genetic Testing and the Consequences to the Public Health. July 22, 2010. http://democrats.energycommerce.house.gov/index.php?q=hearing/hearing-on-direct-to-consumer-genetic-testing-and-the-consequences-to-the-public-health. 2012 April 1.

27.

College of American Pathologists. CAP Urges Increased Oversight of Direct-to-Consumer Laboratory Tests Citing Potential Risk to Patients [press release] July 22, 2010. www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=media_resources%2Fnewsrel_direct_to_consumer.html&_state=maximized&_pageLabel=cntvwr. 2012 April 1.

28.

American Medical Association. Directives of the AMA House of Delegates. Non Physicians' Expanded Scope of Practice (Laboratory Testing and Test Interpretation)D-35.999www.ama-assn.org/ad-com/polfind/Directives.pdf. 2012 April 1.

29.

Alaska Statute §18.15.380. Medical Treatment. www.legis.state.ak.us/basis/statutes.asp?title=18#18.15. 2012 April 1.

30.

Colorado Statute §25-4-408. Distribution of Information. www.michie.com/colorado/lpext.dll?f=templates&fn=main-h.htm&cp=. 2012 April 1.

31.

Illinois Administrative Code §690.1320. Responsibilities and Duties of Healthcare Providers. www.ilga.gov/commission/jcar/admincode/077/077006900H13200R.html. 2012 April 1.

32.

Nevada Revised Statute §441A.270. Instructions of Patients on Prevention and Treatment of Disease. www.leg.state.nv.us/nrs/nrs-441a.html. 2012 April 1.

33.

Intuit Health. http://medemphr.mymedfusion.com/. 2012 April 1.

34.

Microsoft HealthVault Personal. www.healthvault.com/personal/index.aspx. 2012 April 1.

35.

Medivo. www.medivo.com/resources/case-one/. 2012 April 1.

36.

Medivo. www.medivo.com/resources/case-two/. 2012 April 1.

37.

U.S. Food and Drug Administration. OTC—Over the Counter. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm. 2012 April 1.

38.

42 C.F.R. Part 493—Laboratory Requirements. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=48ee8990c77b33334ede1ae1eaeb0171&rgn=div5&view=text&node=42:5.0.1.1.9&idno=42. 2012 April 1.

39.

42 CFR § 493.1241. Part 493—Laboratory Requirements. Subpart K—Quality System for Nonwaived Testing. Standard: Test request. (a) http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=48ee8990c77b33334ede1ae1eaeb0171&rgn=div5&view=text&node=42:5.0.1.1.9&idno=42. 2012 April 1.

40.

Genetics and Public Policy Center Resources. Survey of Direct-to-Consumer Testing Statutes and Regulations. June 2007. www.dnapolicy.org/resources/DTCStateLawChart.pdf. 2012 April 1.

41.

New Hampshire Administrative Rules He-P 817.15(a). Collection Station Standards. www.gencourt.state.nh.us/rules/state_agencies/he-p.html. 2012 April 1.

42.

Fox

. Health Information Online. Pew Internet & American Life Project, May 17, 2005. www.pewinternet.org/Reports/2005/Health-Information-Online/1-Summary-of-Findings.aspx. 2012 April 1.

43.

Fleisher

, Dechene

. Telemedicine and E-Health Law (Healthcare Law Series) New York: Law Journal Press, 2010§1.02[1].

44.

American Telemedicine Association. Core Standards for Telemedicine Operations. November 2007. www.americantelemed.org/files/public/standards/CoreStandards_withCOVER.pdf. 2012 April 1.

45.

Federal of State Medical Boards. Model Guidelines for the Appropriate Use of Internet in Medical Practice. April 2002. www.fsmb.org/pdf/2002_grpol_Use_of_Internet.pdf. 2012 April 1.

46.

American Medical Association House of Delegates. Resolution 317 (A-08). Telemedicine and Medical Licensure. www.ama-assn.org/ama1/pub/upload/mm/377/res317a08.pdf. 2012 April 1.

47.

American Medical Association. Report 4 of the Council on Medical Services. Medical Care Online. June 2001. www.ama-assn.org/resources/doc/cms/doc4.doc. 2012 April 1.

48.

Arizona Revised Statute §36-3602. Delivery of Health Care Through Telemedicine; Requirements; Exceptions. www.azleg.gov/ArizonaRevisedStatutes.asp?Title=36. 2012 April 1.

49.

California Business. Professional Code §2290.5. Enforcement. www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=02001-03000&file=2220-2319. 2012 April 1.

50.

Kentucky Revised Statute §311.5975. Duty of Treating Physician Utilizing Telehealth to Insure Patient's Informed Consent and Maintain Confidentiality. www.lrc.ky.gov/KRS/311-00/5975.PDF. 2012 April 1.

51.

American Telemedicine Association. Informed Consent for Telemedicine Services. www.americantelemed.org/files/public/membergroups/ocular/Ocular_InformedConsentForm.pdf. 2012 April 1.

52.

American Medical Association. American Medical Association Physician Resources. Informed Consent. www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page. 2012 April 1.

53.

36 Oklahoma Statute Annual §6804. Informed Consent. www.oklegislature.gov/osstatuestitle.html. 2012 April 1.

54.

Nebraska Revised Statute §71-8505. Written Statement; Requirements. http://nebraskalegislature.gov/laws/statutes.php?statute=71-8505. 2012 April 1.

55.

Hooper, Lundy & Bookman Inc. Treatise on Healthcare Law. Newark, NJ: LexisNexis® Matthew Bender®, 2010§17Appendix 17A.

56.

Medscape News. Critical Values—More Than 3 Decades of Experience: An Expert Interview with George D. Lundberg, MD. September 4, 2007. www.medscape.com/viewarticle/560353. 2012 April 1.

57.

Joint Commission Journal on Quality and Patient Safety Massachusetts Coalition for the Prevention of Medical Errors. Communication Critical Test Results Safe Practice Recommendations. February 2005. www.macoalition.org/Initiatives/docs/CTRgriswold.pdf. 2012 April 1.

58.

Alabama Code §22-11A-20. Physicians to Instruct Persons on Prevention and Cure of Sexually Transmitted Diseases. http://alisondb.legislature.state.al.us/acas/ACASLoginMac.asp. 2012 April 1.

59.

Alaska Statute §18.15.380. Medical Treatment. www.legis.state.ak.us/basis/statutes.asp?title=18#18.15. 2012 April 1.

60.

Colorado Statute §25-4-408. Distribution of Information. www.michie.com/colorado/lpext.dll?f=templates&fn=main-h.htm&cp=. 2012 April 1.

61.

American Recovery and Reinvestment Act of 2009 (Public Law 111-5. www.gpo.gov/fdsys/pkg/BILLS-111hr1enr/pdf/BILLS-111hr1enr.pdf. 2012 April 1.

62.

Healthcare Information and Management Systems Society. HIMSS Health Information Exchange. HIMSS HIE Guide Work Group. Topic Series: Defining Health Information Exchange, November 2009. www.himss.org/ASP/ContentRedirector.asp?ContentID=76048. 2012 April 1.

63.

American Medical Association. Direct-to-Consumer Diagnostic Imaging Tests. Report of the Council on Ethical and Judicial AffairsCEJA Report 3-A-052005. www.ama-assn.org/resources/doc/code-medical-ethics/8045a.pdf. 2012 April 1.

64.

American Medical Association. AMA Code of Ethics. Opinion 8.045—Direct-to-Consumer Diagnostic Imaging Tests. www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion8045.page. 2012 April 1.