Telemedicine to the Rescue? Mail Order Abortion in Times of Crisis

By: H.R. Fitzmorris

Since the time of the Comstock Act, reproductive healthcare seekers have turned to networks outside of the traditional doctor’s office to circumvent legal and social obstacles. Almost 60 years after the restriction of mail-order contraception was abandoned, Americans have once again—with the aid of the internet— found themselves relying on the post office to meet reproductive healthcare needs through telehealth. And once again, they face the familiar struggle of navigating complex webs of overlapping regulations and political hostility limiting their access to vital resources and information. However, the healthcare crisis spurred by the COVID-19 pandemic, and the resulting regulatory and legal changes, have helped abortion and reproductive healthcare seekers circumvent some of the most burdensome barriers to access. The question now is whether, together, technological advancement in online telehealth and the relaxation of state and federal regulations will be enough to address the “access crisis” that will ensue if the current onslaught of draconian abortion laws survives legal challenges.

The History of Telehealth and How It Works

The concept of telehealth has existed in some form or another for decades. Telehealth, according to the Mayo Clinic, “is the use of digital information and communication technologies, such as computers and mobile devices, to access health care services remotely and manage your health care.” Some clear advantages of telehealth are the ability to access care without the additional cost and burden of traveling to a doctor’s office, increased access to information and records, and increased speed of communication with healthcare providers.

There are, however, drawbacks. The regulatory system managing telehealth providers is fragmented between state and federal requirements, and insurance coverage of telehealth appointments varies according to location and provider. Licensure requirements currently depend on the location of the patient, so some specialist services or medical providers may not be licensed to provide care to patients in certain locations. Additionally, access to telehealth can be impeded by restrictive interpretations of existing state statutes and regulations. For example, state requirements that clinicians conduct an in-person physical exam of a patient before providing telehealth or issuing a prescription can dramatically impede the utility of telehealth for certain patients.

Currently telehealth makes up a small portion of the health industry as a whole. A study conducted from March 1, 2020 through November 30, 2021 revealed that the vast majority of Americans prefer in-person healthcare, “and the total addressable market for telehealth is less than 1% of the health economy.” However, the lessons learned throughout the COVID-19 pandemic may spur further expansion and increased interest in telehealth.

Covid-19 Changes

The COVID-19 pandemic upended the normal operation of innumerable day-to-day activities for most Americans. Once simple tasks became onerous, if not impossible. Notably, routine healthcare became extremely difficult to schedule when COVID exposure risks closed doctors’ offices, and the industry as a whole buckled under extreme demand. Faced with restricted access to in-person office visits due to lockdown orders and overwhelmed providers, patients turned to telemedicine just as quarantined workers turned to Zoom.

In order to facilitate patient access to healthcare, Congress introduced a myriad of temporary regulatory relaxations and measures such as increased Medicare and Medicaid coverage of telehealth services, HIPAA flexibility, and notably, allowed authorized providers to prescribe controlled substances via telehealth, without the need for an in-person medical evaluation.

This affected not just those with pulled muscles, allergic reactions, or people with other routine but time-sensitive ailments that a quick 15-minute chat with a doctor and a quick prescription would clear up. Those experiencing unwanted pregnancies, who faced the daunting prospect of delayed access to care in understandably time-sensitive situations, also were faced with lockdown and quarantine orders in the most abortion-friendly states. In hostile states, the harm of existing restrictive abortion regulations increased under COVID-19 (such as those requiring multiple in-person clinic visits like mandatory waiting periods and ultra-sound requirements). Additionally, some states that were hostile to abortion seized the opportunity to label abortion care as “non-essential,” thereby entirely restricting abortion access.

These restrictions made early access to safe, reliable, and self-administrable abortion care all the more vital. Medical abortion, which is achieved through the simple administration of a single or multi-dose pill, is available up to 10 weeks from conception. Prior to the COVID-19 pandemic, the reach of medical abortion through telemedicine was limited by “specific restrictions on mifepristone in the United States as well as laws that specifically prohibit telemedicine for abortion.” Specifically, the FDA required that either of the two abortion pills be dispensed in a medical clinic, in-person.

However, with the relaxation of the restrictions placed on telemedicine providers that came with the governmental response to COVID, the FDA relaxed the in-person requirement and allowed abortion pills to be obtained by mail, eliminating the need for a doctor visit and the resulting delay in access. Initially this relaxation was temporary, but in December, 2021, the FDA announced that the change will be permanent. Though a welcome reduction in barriers to safe and effective abortion access, states are still free to place their own restrictions on telemedicine providers that offer their services in their jurisdictions. Currently, 19 states prohibit telemedicine facilitated abortions.

Without these barriers, telemedicine can potentially increase abortion access to abortion seekers in underserved, isolated communities. Telemedicine was, in a limited way, able to address severe need in a crisis that strongly necessitated these services. For abortion seekers in the United States, the crisis is far from over. Current restrictive state statutes and attempts to overturn Roe v. Wade continually threaten access to the constitutional right to choose to terminate a pregnancy. In many states, local access to abortion care could disappear entirely in the coming years. What remains unclear is whether further expansion of access to telemedicine will be able to help fill these gaps and what policy changes will be necessary in order to do so. 

The FTC Takes on Health and Fitness Apps’ Rampant Privacy Problems

By: Laura Ames

More and more Americans are turning to mobile health and fitness applications, but many worry about the lack of regulations would ensure that developers of these products keep user information secure and private. The Federal Trade Commission (“FTC”) recently addressed this concern with a policy statement (“Statement”) including app developers among the entities who must follow certain notification procedures after security breaches. However, many question the Statement’s practical effects and whether the FTC had the authority to issue it.  

Health App Trends

Mobile health and fitness apps have gained popularity in recent years, and the COVID-19 pandemic only accelerated this growth. In fact, the United States led the world in health and fitness app downloads as of October 2020 with 238,330,727 downloads that year alone. Even with this increased usage, a recent poll showed that over 60% of U.S. adults felt at least somewhat concerned regarding the privacy of their health information on mobile apps. These worries appear to be well-founded. Flo Health Inc., the developer of a menstrual cycle and fertility-tracking app, currently faces a consolidated class action alleging the company disclosed users’ health information to third parties without users’ knowledge. This is not an isolated concern. A recent study of over 20,000 health and fitness apps found that a third of these apps could collect user email addresses and more than a third transmitted user data to third parties such as advertisers.

The Original Health Breach Notification Rule

Congress enacted the Health Information Technology for Economic and Clinical Health (“HITECH”) Act as an investment in American health care technology. Subtitle D of this Act delegated authority to the FTC to promulgate breach notification requirements for breaches of unsecured protected health information. In 2009, the FTC issued its Health Breach Notification Rule (“HBNR”) covering vendors of personal health records (“PHR”) and PHR-related entities who experienced a security breach. The HBNR requires these entities to notify affected individuals and the FTC. Crucially, the HITECH Act defines a PHR as an electronic record that can be drawn from multiple sources.

The FTC has never enforced the HBNR, but the possibility for changes to the rule has been on the horizon for some time. In 2020, the FTC requested public comments on the HBNR, which functions as a part of their rulemaking process, saying that it was merely a periodic review of the rule. However, before that comment period ended, the Commission issued a policy statement that turned heads.

The FTC Makes a Bold Move

On September 15, the FTC issued a statement with two of the five Commissioners dissenting. The FTC’s stated goal was to clarify the HBNR and put entities on notice of their security breach obligations. The FTC explained that the HBNR is triggered when “vendors of personal health records that contain individually identifiable health information created or received by health care providers” experience a security breach. The first major revelation was that the FTC considers developers of health apps or connected devices as health care providers because they provide health care services or supplies.

Additionally, the FTC stated that it interprets the rule as covering apps that are capable of drawing information from multiple sources, like through a combination of consumer inputs and application programming interfaces (“APIs”). The statement gave two examples of apps that are covered under this understanding. First, an app that collects information directly from users and has the capacity to draw information through an API that enables syncing with a user’s fitness tracker. Second, an app is implicated if it draws information from multiple sources even if the health information only comes from one source. For example, if a consumer uses a blood sugar monitoring app that draws health data only from that consumer’s inputs but also draws non-health data from the phone’s calendar, that app is covered by the HBNR.

Additionally, the FTC sought to remind entities that a breach is not limited to cybersecurity intrusions but also includes unauthorized access to information. Under this interpretation, companies that share information without a user’s authorization would also be subject to the Rule. Although the FTC had not previously enforced the Rule, this Statement also served as signaling the FTC’s willingness to do so. It mentions that businesses could face potential civil penalties of $43,792 per violation per day.

Obviously, these clarifications could subject many app developers and other companies to the FTC’s rule. However, in the eyes of some, including the two dissenting Commissioners, this statement is not a mere clarification but a fundamental policy change. It could not only lead to potential confusion but could also be a breach of the FTC’s statutory authority and rulemaking process.

Critiques and Larger Questions

Some legal experts argue that this statement represents an expansion of the HBNR that could lead to further confusion for app companies and others. The two dissenting FTC Commissioners go further than potential confusion in their statements.

Commissioner Christine S. Wilson argued that this Statement both short-circuits the FTC’s rulemaking process and also improperly increases its statutory authority by expanding the definitions of terms without legislative approval. Commissioner Noah Joshua Phillips agreed that this statement’s first problem is its issuance in the middle of a request for public comment. Wilson pointed out that the FTC’s own business guidance for dealing with the HBNR directly contradicted the statement by saying that “if consumers can simply input their own” health data on a business’ site, for example, a weekly weight input, then the business is not covered by this rule. Wilson also expressed concerns that this interpretation of “health care provider” was a potentially slippery slope. For instance, does Amazon qualify as a health care provider given that users can purchase Band-Aids and other medical supplies through its phone app?

In the coming months, we might see the FTC forcing app developers to notify customers of data disclosures, but the debate around this statement also reveals larger questions concerning health care at the moment. Fundamental questions that once might have seemed easy to answer, such as who qualifies as a health care provider, are growing murkier. In the wake of COVID-19’s effects on telehealth and health technology in general, it seems unlikely that health care will phase out of this continued intermingling with technology. If that is the case, then legislation and regulations surrounding health care will continue to have to scramble to catch up with this rapid technological evolution.

Prove It or Lose It: The FTC’s Standard for Scientific Support of Medical App Claims

Medical-Apps-in-HealthcareBy Julie Liu

Among the countless mobile applications that allow us to control much of our lives, the growing wave of medical apps allows us to manage and improve our health with the convenience of a phone or tablet. But, as illustrated by the Federal Trade Commission’s approval of its final order against the maker of the UltimEyes app, this possibility comes with important limitations. Continue reading

New York Telehealth Law Raises Hopes for Access, Targets Concerns about Billing

Screen Shot 2015-01-20 at 9.11.32 AMBy Alex Boguniewicz

A new year, new legislation, new legal issues. New York rang in 2015 by becoming the 22nd state to enact a telehealth parity law. The law requires that deductibles, co-insurance, and other coverage conditions for telemedicine be treated the same as payments for typical in-person hospital visits. As such, commercial insurers will be required to cover telehealth and telemedicine services, starting at the end of this year. The new law is an exciting development for patients, especially in rural areas, who have previously had limited options in health services. For payers and providers, however, questions remain about the feasibility of this law and how it could impact the entire healthcare reimbursement landscape.

Telehealth and telemedicine have been among the most significant developments in healthcare delivery in decades. Though the terms telehealth and telemedicine are often mistakenly used interchangeably in everyday conversation, they in fact refer to separate modes of delivery, as made explicit by the New York law. Under the statute, “telehealth” means healthcare delivery services through “communications technologies consisting of telephones, remote patient monitoring devices or other electronic means.” The electronic communications facilitate the assessment, diagnosis, consultation, treatment, education, and management and self-management of care while the patient is at the “originating site”—the place where the patient is located when services are provided—and the healthcare provider is at a “distant site.” Telehealth also encompasses non-real-time means of “communicating” health data, and includes devices that transmit a patient’s vital signs to the health care provider. “Telemedicine,” on the other hand, refers to real-time two-way audio-visual communication aimed at assessment, diagnosis, consultation, etc. Thus, telemedicine is more akin to a typical doctor’s visit, with the patient interacting with the healthcare provider as if in the examination room. Continue reading