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Ready or Not … Here Comes a Global Pandemic: A Legal and Practical Overview of the New Normal to Patient Healthcare – Telehealth

What a time to be alive.  Despite this phrase being a personal favorite, I would guess that most of us think of these six-words—or some variation thereof—on a daily basis.  At the beginning of this year, most Americans likely expected the presidential election to dominate the news cycle of 2020.  Fast-forward a few short months, and we are now in the midst of a global pandemic.  The world’s economy has essentially come to a halt, and, as most levels of government have implemented “shelter-in-place” orders, the current status quo primarily consists of sitting at home.  Life as we know it has been flipped upside down, and most of our daily routines have been significantly modified.  This includes seeing a doctor.

The COVID-19 pandemic has created a major shift in the way many healthcare providers would otherwise see and treat their patients—through the use of telehealth (or telemedicine).  In March 2020, the Centers for Medicare and Medicaid (CMS) issued a memo that unequivocally supported the use of telehealth during the current nationwide pandemic: “The widespread availability and usage of telehealth services is vital to combat COVID-19.” 1 So, what is telehealth?

Generally speaking, telehealth is exactly what it sounds like: remotely providing healthcare to patients.  But it is also much more.  This article will address the history, scope and legal issues generally surrounding telehealth, as well as COVID-19’s impact on telehealth and what some physicians are saying about these issues.

Telehealth In General

The Federal Health Services and Resources Administration defines telehealth as “the use of electronic information and telecommunication technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.” 2 Similarly, the Federation of State Medical Boards defines telehealth as “the practice of medicine using electronic communications, information technology or other means between a licensee in one location and a patient in another location with or without an intervening health care provider.” 3 These definitions are broad, and rightfully so. 

Generally speaking, telehealth is subdivided into four categories (or modalities): (1) real-time, (2) store-and-forward, (3) remote patient monitoring (RPM) and (4) mobile health (mHealth). 4 The first two—real-time and store-and-forward—are focused on patient consultation and treatment much like a face-to-face doctor’s visit. 5 Remote patient monitoring “collects patient information electronically and transmits it to a provider at another location to allow tracking and monitoring of that patient.” 6 Finally, mHealth primarily concerns mobile phone applications that are marketed directly to consumers. 7

Indeed, with the advancements in technology over the last several decades, some form of telehealth is being utilized in nearly every aspect of patient care—from cellphone applications that provide live, in-time cardiac readings to cardiologists, to a simple five-minute phone call with a family physician regarding common cold symptoms.  But despite telehealth’s never-ending list of potential uses, one thing remains constant: the use of communicative technology.

The use of communicative technology does not necessarily mean “electronic” communicative technology.  The earliest form of telehealth can be traced to the use of smoke signals to communicate the presence of deadly diseases within certain tribes. 8 Telehealth, however, truly found its origins after the invention of the telephone in the mid-to-late 19th century.  The Lancet—one of the oldest peer-reviewed medical journals—published an article in 1879 that discussed the use of telephones in reducing unnecessary office visits. 9 Fast-forward nearly 50 years after the Lancet article, and innovative minds were percolating at the potential uses of telehealth.  For example, in 1929, an article in Science and Invention magazine foresightedly contemplated the use of video technology in diagnosing and treating patients—a service that came to fruition in the 1960s. 10 Now, after the introduction of high-speed internet and global technology firms, telephone and video transmission is truly telehealth at its most primitive form. 

Indeed, the advancement in modern-day technology has morphed telehealth into a multi-faceted, multi-purposed aspect of patient care and treatment.  Telehealth has invaded nearly every medical specialty, including surgery, which means there are significant legal and regulatory considerations for providers offering telehealth to its patients.

Legal and Regulatory Concerns

Given the broad scope of telehealth and the current COVID-19 crisis, this article will primarily focus on the considerations surrounding the patient consultation/treatment types of telehealth: “real-time” and “store-and-forward.”  As with most areas of patient consultation/treatment being regulated by state government, these areas of telehealth are no different.  Of course, this means providers in New York, for example, may be subject to different laws and regulations than providers in Arizona.  Some states, like California, 11 have passed entire statutory acts that pertain exclusively to telehealth issues.

Licensing Issues

In the traditional healthcare setting, it is no surprise that physicians must be licensed by the state in which the patient is located.  Despite telehealth allowing providers to remotely consult and treat patients, that does not necessarily change the licensing requirements.  As of November 2019, the Federation of State Medical Boards reported the following statistics regarding licensing for telehealth activities:

  • Forty-nine state boards, plus the medical boards of District of Columbia, Puerto Rico and the Virgin Islands, require that physicians engaging in telemedicine are licensed in the state in which the patient is located.
  • Twelve state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.
  • Six state boards require physicians to register if they wish to practice across state lines. 12

Informed Consent Issues

In a growing number of states, providers who wish to engage in patient consultation and treatment via telehealth are required to acquire informed consent from the patient.  For example, in Mississippi, a provider must obtain “[s]igned consent for treatment using telehealth” and document a “[m]edically appropriate reason telehealth was utilized to provide services.” 13 Some states, like New Jersey for example, require informed consent for the use of telehealth only in certain areas of medicine, like telepsychiatry: “Consumers must provide informed consent to participate in any service utilizing telepsychiatry. If they choose to participate, the clients must be informed and aware of the location of the psychiatrist/APN providing the telepsychiatry service.” 14 As of October 2019, 26 states require some form of informed consent to consult and treat a patient using telehealth. 15

Privacy Issues

The security of sensitive health and personal information is undoubtedly a major concern to patients—not only in the traditional healthcare setting, but also in telehealth.  Under the Health Insurance Portability and Accountability Act of 1996, commonly referred to as HIPAA, healthcare providers are required to, among other things, implement safeguards to protect patients’ protected health information (PHI), as well as notify patients in the event of a breach. 16 Despite there not being any specific HIPAA laws pertaining exclusively to telehealth, 17 several HIPAA-related issues routinely arise in telehealth, especially in the context of electronic PHI (ePHI).

For example, as it pertains to ePHI, healthcare providers are required to, among other things, implement (1) a system of secure communication to protect the integrity of ePHI and (2) a system to monitor communications that contain ePHI to prevent breaches. 18 Assume, therefore, that a physician uses a social media application to communicate with a friend (and patient) who is experiencing common cold symptoms.  Unless this social media application has been deemed a “secure communication” and the physician has implemented a system to monitor the application for breaches, then that physician would be in violation of HIPAA.  Fortunately, many companies offer solutions that meet HIPAA’s ePHI communication standards.

In telehealth, it is worth noting that security concerns are not just limited to the security of the communicative technology or device being used, but also the physical location of the provider and patient.  Take the physician and patient mentioned in the example above, but now assume that they are communicating through a HIPAA-compliant channel of communication.  Assume that the physician is at home and that the patient is in a crowded airport.  The physician now must ensure that he/she is in a secure location within the home so that family members do near overhear the conversation, and the patient must likewise ensure that he/she is in a location so that a passerby at the airport does not overhear the ePHI. 

These are significant concerns that could lead to the accidental release of ePHI.  Before engaging in a virtual office visit, providers should ensure that everyone is in a secure location and that no one will overhear the conversation other than the provider, the patient and any authorized individual.  If it is not possible to not be in the presence of others, the U.S. Department of Health and Human Services (HHS) recommends taking precautions such as “using lowered voices, not using speakerphone, or recommending that the patient move to a reasonable distance from others.” 19

Telehealth and COVID-19

As discussed above, telehealth has made a significant impact on the healthcare industry over the last several decades.  But that does not mean the majority of patients use telehealth for their routine doctor’s visits.  Indeed, waiting rooms around the country were generally full—that is, until COVID-19.

Almost overnight, governmental authorities around the country issued shelter-in-place orders, which largely confined people to their homes.  Moreover, in an attempt to “flatten the curve,” many healthcare providers opted to see most of their non-emergent patients through telehealth visits to reduce populated waiting rooms and to ensure safe distancing.  Because there was very little warning before this massive telehealth need arose, the federal government was forced to step in and issue emergency regulations and guidance on the use of telehealth during the COVID-19 pandemic.

For example, “[c]overed health care providers will not be subject to penalties for violations of the HIPAA . . . that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency.” 20  In determining whether a provider has acted in good faith, HHS has instructed that the use of “public-facing remote communication products, such as TikTok, Facebook Live, Twitch or a public chat room” likely constitutes a bad faith HIPAA violation. 21  In providing this guidance, HHS states that the following telehealth means are “non-public-facing” and, therefore, permissible:

  • Apple FaceTime
  • Facebook Messenger video chat
  • Google Hangouts video
  • Whatsapp video chat
  • Zoom
  • Skype 22

In addition to HIPAA, CMS is, as of March 6, 2020, reimbursing providers for the use of telehealth across the entire country. 23  Prior to the COVID-19 crisis, Medicare would only reimburse providers for telehealth services provided to patients living in rural areas and confined to a medical facility. 24  Moreover, under the current emergency regulations, CMS is waiving the requirement that patients have an existing relationship with the telehealth provider. 25  These regulations are, of course, temporary and will expire at the appropriate time following the COVID-19 pandemic.

Physician Insights on Telehealth During COVID-19

I interviewed three physicians—a gastroenterologist, a nephrologist and an otolaryngologist—regarding their current experience with telehealth under the COVID-19 pandemic.  Prior to the pandemic, all three of the physicians saw their patients exclusively through in-person, face-to-face visits—meaning the immediate need to use telehealth was a significant change in their respective practices.  When asked about advantages to telehealth, this is what they had to say:

  • “Easier access to patients.”
  • “We can reach a larger footprint geographically.”
  • “It is a great service for our patients who struggle with having to make travel arrangements”
  • “It also is more efficient in the sense if a patient ‘no shows,’ we can just call them back later, as opposed to when they book a clinic time and they don’t show that slot remains open.”

When questioned about disadvantages of telehealth, they said the following:

  • “The challenge is the lack of a physical exam—plus, it’s harder to get a sense of someone’s illness over the phone.”
  • “Given our patient demographic and lack of patients being ‘connected,’ it can be a challenge to arrange telehealth visits.”
  • “Despite most patients having smart phones or computers, they do not always have high-speed internet or reliable cellular service.”
  • “Being unable to physically see patients and assess them—it can be a clinical challenge making a diagnosis.”
  • “For me the greatest challenge is lack of ability to thoroughly examine most of the anatomy relevant to my practice.”

All three of these physicians recognized that the future of medicine likely included an increased usage of telehealth in their practices—global pandemic or not.

Conclusion

No one knows when life will return to “normal.”  Until then, we will continue to wash our hands more frequently than before, keep a safe distance from others, wear masks while grocery shopping and see our healthcare providers remotely through the use of technology.  But even after most things return to the way they used to be, the increased reliance on telehealth may be here to stay.  After all, automation and technology have significantly impacted most industries, including healthcare, over the past two decades.  There is no reason to think that trend will not continue.


[1] Ctrs. for Medicaid and Medicare Servs., FAQs on Availability and Usage of Telehealth Services through Private Health Insurance Coverage in Response to Coronavirus Disease 2019 (COVID-19) (March 24, 2020), https://www.cms.gov/files/document/faqs-telehealth-covid-19.pdf.

[2] Health Res. & Servs. Admin., Telehealth Programs (Aug. 2019), https://www.hrsa.gov/rural-health/telehealth.

[3] Rita M. Marcoux, RPh, MBA & F. Randy Vogenberg, RPh, PhD, Telehealth: Applications From a Legal and Regulatory Perspective, Pharmacy and Therapeutics, (Sept. 2016), 567–570, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5010268/

[4] Id.

[5] Id.

[6] Id.

[7] Id.

[8] Nakajima I, Sastrokusumo U, Mishra SK, Komiya R, Malik AZ, Tanuma T, The Asia Pacific Telecommunity’s Telemedicine Activities, HEALTHCOM 2006 8th International Conference on E-Health Networking, Applications and Services (2006-2008).

[9] Thomas S. Nesbitt, M.D., M.P.H., The Evolution of Telehealth: Where Have We Been and Where Are We Going?, Board on Health Care Services; Institute of Medicine, Washington (DC): National Academies Press (US), (Nov. 20, 2012), https://www.ncbi.nlm.nih.gov/books/NBK207141/

[10] Id., see also Roger Allan, A Brief History of Telemedicine, Electronic Design (June 28, 2006), https://www.electronicdesign.com/technologies/components/article/21770508/a-brief-history-of-telemedicine.

[11] The Telemedicine Development Act of 1996, which was repealed and replaced with The Telehealth Advancement Act of 2012.

[12] Fed,n of State Med. Bds., Telemedicine Policies: Board by Board Overview, (November 2019), https://www.fsmb.org/siteassets/advocacy/keyissues/telemedicine_policies_by_state.pdf

[13] MS Admin. Code 23, Part 225, Rule 1.6(A).

[14] State of New Jersey, Dept. of Health & Human Servs., Telepsychiatry Newsletter (Dec. 2013), Vol. 23, No. 21, http://www.njha.com/media/292399/Telepsychiatrymemo.pdf

[15] Telemedicine laws and developments: A state-by-state analysis, Becker’s Health IT, (2020), https://www.beckershospitalreview.com/healthcare-information-technology/telemedicine-laws-and-developments-a-state-by-state-analysis.html

[16]U.S. Dept. Health & Human Servs. Office for Civil Rights, Privacy, Security, and Electronic Health Records, https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/consumers/privacy-security-electronic-records.pdf

[17] Ctr. For Connected Health Policy, HIPAA, https://www.cchpca.org/telehealth-policy/hipaa

[18] HIPAAnswers, What is HIPAA Compliant Telemedicine?, (Nov. 2, 2017), https://www.hipaanswers.com/what-is-hipaa-compliant-telemedicine/

[19] U.S. Dept. Health & Human Servs. Office for Civil Rights,  FAQs on Telehealth and HIPAA During the COVID-19 Nationwide Public Health Emergency, at 3, https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf

[20] Id. at 2

[21] Id. at 4.

[22] Id.

[23] Ctrs. for Medicaid and Medicare Servs., Medicare Telehealth Frequently Asked Questions (FAQs) (March 17, 2020), at 1, https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf

[24] Id.

[25] Id. at 2.

Finis

Citations

  1. Ctrs. for Medicaid and Medicare Servs., FAQs on Availability and Usage of Telehealth Services through Private Health Insurance Coverage in Response to Coronavirus Disease 2019 (COVID-19) (March 24, 2020), https://www.cms.gov/files/document/faqs-telehealth-covid-19.pdf Jump back to footnote 1 in the text
  2. Health Res. & Servs. Admin., Telehealth Programs (Aug. 2019), https://www.hrsa.gov/rural-health/telehealth. Jump back to footnote 2 in the text
  3. Rita M. Marcoux, RPh, MBA & F. Randy Vogenberg, RPh, PhD, Telehealth: Applications From a Legal and Regulatory Perspective, Pharmacy and Therapeutics, (Sept. 2016), 567–570, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5010268/ Jump back to footnote 3 in the text
  4. Id. Jump back to footnote 4 in the text
  5. Id. Jump back to footnote 5 in the text
  6. Id. Jump back to footnote 6 in the text
  7. Id. Jump back to footnote 7 in the text
  8. Nakajima I, Sastrokusumo U, Mishra SK, Komiya R, Malik AZ, Tanuma T, The Asia Pacific Telecommunity’s Telemedicine Activities, HEALTHCOM 2006 8th International Conference on E-Health Networking, Applications and Services (2006-2008). Jump back to footnote 8 in the text
  9. Thomas S. Nesbitt, M.D., M.P.H., The Evolution of Telehealth: Where Have We Been and Where Are We Going?, Board on Health Care Services; Institute of Medicine, Washington (DC): National Academies Press (US), (Nov. 20, 2012), https://www.ncbi.nlm.nih.gov/books/NBK207141/ Jump back to footnote 9 in the text
  10. Id., see also Roger Allan, A Brief History of Telemedicine, Electronic Design (June 28, 2006), https://www.electronicdesign.com/technologies/components/article/21770508/a-brief-history-of-telemedicine. Jump back to footnote 10 in the text
  11. The Telemedicine Development Act of 1996, which was repealed and replaced with The Telehealth Advancement Act of 2012. Jump back to footnote 11 in the text
  12. Fed,n of State Med. Bds., Telemedicine Policies: Board by Board Overview, (November 2019), https://www.fsmb.org/siteassets/advocacy/key-issues/telemedicine_policies_by_state.pdf Jump back to footnote 12 in the text
  13. MS Admin. Code 23, Part 225, Rule 1.6(A). Jump back to footnote 13 in the text
  14. State of New Jersey, Dept. of Health & Human Servs., Telepsychiatry Newsletter (Dec. 2013), Vol. 23, No. 21, http://www.njha.com/media/292399/Telepsychiatrymemo.pdf Jump back to footnote 14 in the text
  15. Telemedicine laws and developments: A state-by-state analysis, Becker’s Health IT, (2020), https://www.beckershospitalreview.com/healthcare-information-technology/telemedicine-laws-and-developments-a-state-by-state-analysis.html Jump back to footnote 15 in the text
  16. U.S. Dept. Health & Human Servs. Office for Civil Rights, Privacy, Security, and Electronic Health Records, https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/consumers/privacy-security-electronic-records.pdf Jump back to footnote 16 in the text
  17. Ctr. For Connected Health Policy, HIPAA, https://www.cchpca.org/telehealth-policy/hipaa Jump back to footnote 17 in the text
  18. HIPAAnswers, What is HIPAA Compliant Telemedicine?, (Nov. 2, 2017), https://www.hipaanswers.com/what-is-hipaa-compliant-telemedicine/ Jump back to footnote 18 in the text
  19. U.S. Dept. Health & Human Servs. Office for Civil Rights,  FAQs on Telehealth and HIPAA During the COVID-19 Nationwide Public Health Emergency, at 3, https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf Jump back to footnote 19 in the text
  20. Id. at 2 Jump back to footnote 20 in the text
  21. Id. at 4. Jump back to footnote 21 in the text
  22. Id. Jump back to footnote 22 in the text
  23. Ctrs. for Medicaid and Medicare Servs., Medicare Telehealth Frequently Asked Questions (FAQs) (March 17, 2020), at 1, https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf Jump back to footnote 23 in the text
  24. Id. Jump back to footnote 24 in the text
  25. Id. at 2. Jump back to footnote 25 in the text