Administrative Health Care Annotated Bibliography

64 AJN ▼ September 2016 ▼ Vol. 116, No. 9 ajnonline.com

Legal Considerations in Telehealth and Telemedicine

The delivery of nursing services through the Internet or any other electronic channels con- stitutes the practice of nursing.

—National Council of State Boards of Nursing, 2014

Technology and science change faster than the legal system. Technologic advances have per-mitted nurses to monitor patients remotely and interact with medical devices. Telehealth (also called telemedicine—more on that below) is the de- livery of health care remotely, in some cases virtually, through video or audio technology. It can address access and provider-shortage issues by permitting long-distance health care with patients at one site and providers at another. Telehealth can take many forms, such as the remote monitoring of medical de- vices; wearable tracking devices; video monitoring (both live and stored); nursing call centers; telephone triage; and the use of computers, tablets, cell phones, or other modes of electronic communication between provider and patient. About 10 million patients a year receive telemedicine services in the United States (that number includes mental health services).1, 2

As telehealth modalities become integrated into practice, however, issues of licensure, privacy, secu- rity, confidentiality, scope of practice, and definitions of the practice of nursing all need to be considered. When is the provider–patient relationship created? Which state is the nurse required to be licensed in if a patient is in one and the nurse is in another? Which state’s scope of practice determines her or his role?

DEFINITIONS Although the terms telemedicine and telehealth are of- ten used interchangeably, telemedicine applies more narrowly to clinical services and telehealth more broadly to general health care, such as patient educa- tion and monitoring.3 Telehealth is provided in several modalities4: • real-time, or synchronous, communication

such as telephone, Webcam, or audio or video links

• the storage and forwarding of information, such as diagnostic-imaging data

• remote patient monitoring, such as at-home vital sign measurement or blood glucose level testing

• mHealth (mobile health, also written m-health), which can include the use of wearable devices, cell phones, or smartphone applications The definitions of telehealth or telemedicine vary

somewhat from organization to organization: • The Department of Health and Human Services

defines telehealth as the “use of technology to de- liver health care, health information or health edu- cation at a distance.”5

• The National Council of State Boards of Nursing (NCSBN) says it’s “the practice of nursing deliv- ered through various telecommunications tech- nologies, including high speed Internet, wireless, satellite and televideo communications.” The NCSBN further states that “[t]he nurse engages in the practice of nursing by interacting with a client at a remote site to electronically receive the client’s health status, initiate and transmit therapeutic in- terventions and regimens, and monitor and record the client’s response and nursing care outcomes.”6

• The American Telemedicine Association’s defini- tion of telemedicine is “the use of medical infor- mation exchanged from one site to another via electronic communications to improve a patient’s clinical health status.”7

• The Federation of State Medical Boards defines telemedicine as “the practice of medicine using electronic communications, information technol- ogy or other means between a licensee in one lo- cation and a patient in another location with or without an intervening health care provider.”8

LEGAL STANDARDS OF PRACTICE When engaging in telemedicine, it is important for a nurse to understand legal and regulatory require- ments. Nurses must still adhere to traditional clini- cal standards of care and practice within the scope authorized by law. It is particularly challenging in telehealth to establish and meet evidence-based stan- dards. Krupinski and Bernard have noted,9

As the technology changes, it is incumbent on the telehealth community to verify the reliability

LEGAL CLINIC

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By Edie Brous, JD, MS, MPH, RN

and validity of these technologies before use in routine care, and to establish standards and practice guidelines for their use. However, this takes time, effort, and usually funds, and it is often argued that rigorous evaluation studies are done just as the technology becomes ob- solete.

Telehealth best practices and guidelines are still be- ing developed and determined by regulatory agencies, but the legal system lags behind technology. Laws and regulations must, of necessity, be modified by slower systems and are always playing catch-up. The Tri- Council for Nursing (an alliance of the American As- sociation of Colleges of Nursing, the American Nurses Association [ANA], the American Organization of Nurse Executives, and the National League for Nurs- ing) and the NCSBN have noted, “With the advent of the information age and digital era, nursing reg- ulation must address the unique needs of interstate practice enabled by telehealth technologies.”10 It is important to adhere to the laws as they exist in the moment while keeping abreast of changes. This is an evolving area of the law, as the Center for Con- nected Health Policy reports: “In the 2015 legisla- tive session, [42] states have introduced over 200 telehealth-related pieces of legislation.”11

WHERE DOES TELEHEALTH REALLY LIVE? Nurses must hold licenses in the state in which they reside but also must be licensed or allowed to prac- tice in the state in which their patients are located.4 It is important to know each state’s requirements. Pro- viding care that exceeds a state’s scope-of-practice limits is considered practicing without a license and can expose the nurse to both civil and criminal liabil- ity, as well as licensure discipline.

In determining whether a nurse can legally deliver telehealth services to patients in a different state, the question is not where the patient is geographically lo- cated, but where the nurse is practicing: is a telehealth nurse practicing in the state from which services are provided or in the state where they are received? Opin- ions vary. The ANA believes that the nurse is practic- ing in the state where the nurse is located,12 but the position of the NCSBN is that the nurse is practicing where the patient is located.13 And some states require providers using telemedicine technology across state lines to have a valid license in the state where the pa- tient is located,3 whereas other states’ nurse practice acts are silent on the subject.

In actuality, the scope-of-practice and nursing reg- ulations that apply to the telehealth nurse–patient encounter are based on the laws in place where the patient is located. Additionally, there is no federal

licensure for physicians, only state licensure, which means that nurses can only take orders from physi- cians licensed in the state where the patient is located, not where the nurse is located.8

Telehealth nurses should understand that malprac- tice lawsuits that arise in the course of a telehealth nurse–patient relationship will be brought in the state where the patient is located. The nurse would there- fore be forced to defend the lawsuit in a state she or he was never physically in during the relationship. It is also important for the nurse to determine—before engaging in telehealth—whether her or his malprac- tice insurance policy covers telehealth practice.

THE NURSING LICENSURE COMPACT These restrictions also apply to nurses covered under the Nursing Licensure Compact (NLC). The NLC is an interstate mutual recognition model of licensure that permits nurses who are licensed in one compact- member state to practice in another compact-member state. Currently, 25 states are members of the NLC. Nurses are granted multistate licensure privileges, but they still must follow the laws and regulations of the state in which they are practicing. Because scope-of- practice limitations vary by state, it is critical for a nurse to know the regulations of any state in which she or he practices. Nurses who act outside of their legal scope, or in violation of nurse practice acts or other regulations, expose themselves to licensure dis- cipline. The nurse can both lose the multistate privi- lege and be disciplined by the states in which she or he holds a license.

Nurses who practice telehealth with patients throughout the country must be legally authorized to deliver those services in all jurisdictions. They need

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LEGAL CLINIC

to have multistate privileges and valid individual li- censure in all states and territories that do not cur- rently participate in the NLC. To encourage more state participation in the NLC, the NCSBN signifi- cantly revised the original compact, adopting the new version in May 2015, when it also approved model legislation for states to adopt a licensure compact for advanced practice nurses.14

A state-by-state analysis of physician standards and licensure noted that “[p]rofessional licensure portability and practice standards for providers us- ing telemedicine are some of the biggest challenges for health care providers considering telemedicine adoption.”15 Similarly, the ANA stated,16

As advocates for the profession and health care consumers/patients, nurses should thought- fully consider how their practice and priorities might be affected by these different license por- tability models. It is up to nurses to engage in the effort to ensure that changes in licensure policy reflect the profession’s needs, values, and commitment to health care consumer/ patient safety.

PRIVAC Y AND CONFIDENTIALITY Nurses have a duty to safeguard patient information and prevent unauthorized access to medical records. When engaging in telehealth, nurses must meet medi- cal information and patient privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), as well as state privacy laws, organiza- tional policies, and ethical standards. Devices that contain protected health information (PHI) must meet security requirements, and wireless communi- cations must have cybersecurity protection. Like pa- per documents, electronic files must be stored in a manner that ensures privacy and confidentiality. Au- dio and video recordings are susceptible to hacking. All providers should be educated on how to prevent data breaches when communicating information and transmitting images or audio or video files electroni- cally, and on how to respond when they do occur.

Providers can have a false sense of security in us- ing mHealth apps, too. A recent report noted that the majority of mobile health apps contain critical se- curity vulnerabilities. Some of the vulnerabilities have patient safety implications because they “could result in application code tampering, reverse-engineering, privacy violations, and data theft. In addition to sen- sitive data being taken, the vulnerabilities could lead to a health app being reprogrammed to deliver a le- thal dose of medication.”17 Patient satisfaction is also at risk, as another report indicates: “80% of consumers indicated they would change providers if

they knew the apps they were using were not secure. And 82% of consumers would change providers if they knew alternative apps offered by similar service providers were more secure.”18

To adequately meet HIPAA standards, any elec- tronic systems that transmit or store electronic in- formation about patients must be operated and monitored by computer technicians with expertise in security measures. Providers should also understand that PHI includes more than medical information. Anything that can identify a patient can be considered PHI, including e-mail addresses, birth dates, telephone numbers, Internet protocol addresses, and so on. State privacy laws can be more stringent and spe cifically address medical devices and telehealth apps. The Na- tional Telehealth Policy Resource Center provides state-specific information on laws, regulations, re- imbursement policies, and pending legislation.19

BARRIERS A 2014 national survey conducted by the Robert Graham Center for Policy Studies in Family Medicine and Primary Care (created by the American Academy of Family Physicians) found that, although most fam- ily physicians believed that telehealth can improve access to and continuity in care, only 15% reported actually having used telehealth in the previous year. Barriers cited for not using it were a lack of training, inadequate mechanisms for obtaining reimbursement, technology costs, and liability issues.20 This is consis- tent with what the Institute of Medicine (IOM) iden- tifies as the “seven deadly barriers” to the “use of telemedicine modalities”2: • money • regulations • hype • adoption • technology • evidence • success

Several examples of such barriers in action can be found in a project implemented at the Henry Ford Health System.21 Home care nurses identified patients at risk for medication noncompliance. Funding was obtained for a one-year trial program in which tele- health medication dispensers were installed in the pa- tients’ homes and caregivers were trained to fill the dispensers. The dispensers uploaded daily activity and communicated power failures or missed doses over landlines. The dispensers sent messages to patients, reminding them to do such things as measure their blood pressure or change fentanyl patches.

The project successfully reduced hospitalizations and readmissions related to medication noncompli- ance. It prevented missed doses and adverse drug

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responses related to overdosage when patients forgot they had already taken their medications. However, despite achieving a 96% compliance rate using these telehealth medication dispensers, Henry Ford was un- able to expand the program. Many patients could not access the system because it required a landline. The cost of monitoring, $65 per month, was not covered by insurance and many of the participants could not afford to assume the burden (Mary Hagen, e-home care supervisor, telephone interview, January 5, 2016).

Ultimately, the program was compromised by in- adequate technology, a lack of insurance coverage, and an inability to obtain funding.

CONCLUSION In its landmark publication, The Future of Nursing: Leading Change, Advancing Health, the IOM noted that “[t]here is perhaps no greater opportunity to transform practice than through technology.”22 With the growth in remote patient-monitoring and biomet- rics technology, nursing practice will continue to be transformed. It will be essential for nurses to be aware of the legal and regulatory implications of this evolv- ing change in nursing practice. ▼

Edie Brous is a nurse and attorney in New York City and the coordinator of Legal Clinic: [email protected]. The au- thor has disclosed no potential conflicts of interest, financial or otherwise.

REFERENCES 1. American Psychological Association, Practice—Legal and

Regulatory Affairs. Telepsychology 50-state review [slides]. Washington, DC; 2013 Oct. http://www.apapracticecentral. org/advocacy/state/telehealth-slides.pdf.

2. Lustig TA, Board on Health Care Services, Institute of Medi- cine of the National Academies. The role of telehealth in an evolving health care environment: workshop summary. Wash- ington, DC: National Academies Press; 2012. http://www.nap. edu/catalog/13466/the-role-of-telehealth-in-an-evolving-health- care-environment.

3. Centers for Medicare and Medicaid Services. Telemedicine. n.d. https://www.medicaid.gov/medicaid-chip-program-information/ by-topics/delivery-systems/telemedicine.html.

4. National Conference of State Legislators. Telehealth policy trends and considerations. Denver; 2015. http://www.ncsl.org/ documents/health/telehealth2015.pdf.

5. Health Resources and Services Administration (HRSA). What is telehealth? n.d. http://www.hrsa.gov/healthit/toolbox/ RuralHealthITtoolbox/Telehealth/whatistelehealth.html.

6. National Council of State Boards of Nursing. The National Council of State Boards of Nursing (NCSBN) position paper on telehealth nursing practice. Chicago; 1997/2014. https:// www.ncsbn.org/14_Telehealth.pdf.

7. American Telemedicine Association. What is telemedicine? 2012. http://www.americantelemed.org/about-telemedicine/ what-is-telemedicine#.V1nMpvkrKM8.

8. Federation of State Medical Boards (FSMB). Model policy for the appropriate use of telemedicine technologies in the prac- tice of medicine. Euless, TX; 2014 Apr. https://www.fsmb.org/ Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_ Policy.pdf.

9. Krupinski EA, Bernard J. Standards and guidelines in tele- medicine and telehealth. Healthcare 2014;2:74-93.

10. TriCouncil for Nursing and the National Council of State Boards of Nursing. Interstate practice, education, and licen- sure: changing practice, evolving regulation; 2014 Nov. http:// www.nursingworld.org/MainMenuCategories/Policy-Advocacy/ State/Legislative-Agenda-Reports/LicensureCompact/TriCouncil- InterstatePracticeEducationLicensure.pdf.

11. Center for Connected Health Policy, the National Telehealth Policy Resource Center. State telehealth laws and Medicaid pro- gram policies: a comprehensive scan of the 50 states and Dis- trict of Columbia. Sacramento, CA; 2015 Jul. http://cchpca.org/ sites/default/files/resources/STATE%20TELEHEALTH%20 POLICIES%20AND%20REIMBURSEMENT%20REPORT %20FINAL%20%28c%29%20JULY%202015.pdf.

12. American Nurses Association. Interstate nurse licensure com- pact. Silver Spring, MD; 2015. http://www.nursingworld.org/ State-LicensureCompact.aspx.

13. National Council of State Boards of Nursing. Nurse licen- sure compact. n.d. https://www.ncsbn.org/nurse-licensure- compact.htm.

14. National Council of State Boards of Nursing. Advanced practice registered nurse compact; 2015 May 4. https:// www.ncsbn.org/APRN_Compact_Final_050415.pdf.

15. Thomas L, Capistrant G. State telemedicine gaps analysis: physician practice standards and licensure. Washington, DC: American Telemedicine Association 2015 May. Gaps analysis series; http://www.americantelemed.org/docs/default-source/ policy/50-state-telemedicine-gaps-analysis--physician-practice- standards-licensure.pdf?sfvrsn=14.

16. American Nurses Association, Congress on Nursing Practice and Economic Licensure Portability Workgroup. Nursing li- censure portability. Silver Spring, MD; 2013 Apr. ANA is- sue brief; http://www.nursingworld.org/MainMenuCategories/ Policy-Advocacy/Positions-and-Resolutions/Issue-Briefs/Nursing- Licensure-Portability.pdf.

17. Leventhal R. Report: majority of mHealth apps contain criti- cal security vulnerabilities. Healthcare Informatics 2016 Jan 13. http://www.healthcare-informatics.com/news-item/report- majority-mhealth-apps-contain-critical-security-vulnerabilities.

18. Arxan Technologies. 5th annual state of application security report: perception vs. reality [consolidated edition]. Bethesda, MD; 2016 Jan. https://www.arxan.com/wp-content/uploads/ 2016/01/State_of_Application_Security_2016_Consolidated_ Report.pdf.

19. Center for Connected Health Policy, the National Telehealth Policy Resource Center. State laws and reimbursement policies. 2016. http://cchpca.org/state-laws-and-reimbursement-policies.

20. Klink K, et al. Family physicians and telehealth: findings from a national survey. Washington, DC: Robert Graham Center for Policy Studies in Family Medicine and Primary Care; 2015 Oct 30. Access to care; http://www.graham-center.org/content/dam/ rgc/documents/publications-reports/reports/RGC%202015%20 Telehealth%20Report.pdf.

21. American Telemedicine Association. Increasing medication compliance in high risk patients by utilizing electronic medica- tion dispensers. Washington, DC; 2012. Telemedicine case studies; http://www.americantelemed.org/about-telemedicine/ telemedicine-case-studies/case-study-full-page/increasing- medication-compliance-in-high-risk-patients-by-utilizing- electronic-medication-dispensers.

22. Committee on the Robert Wood Johnson Foundation Initia- tive on the Future of Nursing, at the Institute of Medicine. The future of nursing: leading change, advancing health. Washington, DC: National Academies Press; 2011. http:// www.nationalacademies.org/hmd/Reports/2010/The-Future- of-Nursing-Leading-Change-Advancing-Health.aspx.