Tag: femtech

Introduction

The Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization granted state legislatures the authority to regulate abortion. The Court’s decision quickly led states, such as Texas and Arkansas, to enact trigger bans for the procedure. Prior to the Court’s ruling, data brokers had already begun selling location data for individuals visiting abortion facilities through ordinary apps. This data often provided details to where the individual traveled from and how long they stayed at the facility.

In the wake of Dobbs, concerns have come to light regarding the potential misuse of sensitive personal health data originating from period tracking apps. Questions have arisen concerning whether “femtech” app data can be used to identify and prosecute individuals violating abortion laws. Due to lax federal laws and regulations in the United States, the onus falls on femtech companies to immediately and proactively find ways to protect users’ sensitive health data.

What is “Femtech’?

The term “femtech” was coined in 2016 by Ida Tin, the CEO and co-founder of period tracking app Clue. Femtech refers to health technology directed at supporting reproductive and menstrual healthcare. The femtech industry is currently estimated to have a market size between $500 million and $1 billion. Femtech apps are widely used with popular period-tracking app Flo Health touting more than 200 million downloads and 48 million monthly users.

Apps like Clue, Flo Health, and Stardust allow individuals to record and track their menstrual cycle to receive personalized predictions on their next period or their ovulation cycle. Although femtech apps collect highly sensitive health data, they are largely unregulated in the United States and there is a growing push for a comprehensive framework to protect sensitive health data that the apps collect from being sold or provided to third parties and law enforcement.

Current Regulatory Framework

Three federal agencies have regulatory authority over femtech apps – the Federal Trade Commission (“FTC”), United States Food and Drug Administration (“FDA”), and the Department of Health and Human Services (“HHS”). Their authority over femtech data privacy is limited in scope. Furthermore, while the FDA can clear the apps for contraceptive use, greater focus has been put on the FTC and HHS in regulating femtech. The Health Insurance Portability and Accountability Act (HIPAA), administered by the HHS, fails to protect sensitive health data from being collected and sold, and femtech apps are not covered under the Act. The FTC is currently exploring rules on harmful commercial surveillance and lax data security practices following President Joe Biden’s July 2022 executive order that encourages the FTC to “consider actions . . . to protect consumers’ privacy when seeking information about and provision of reproductive health care services.” The executive order’s definition of “reproductive healthcare services” does not, however, seem to include femtech apps. Thus, a massive gap remains in protecting sensitive health data consumers willingly provide to femtech app who may sell or provide such data to law enforcement or third parties. Femtech apps generally have free and paid versions for users, which makes the issue all the more immediate.

The unease based on potential misuse of health data collected by “femtech” apps heightened following the FTC’s complaint against Flo. The agency alleged the app violated Section 5 of the Federal Trade Commission Act (“FTCA”) by misleading consumers on how it handled sensitive health data. While the app promised to keep sensitive health data private, the FTC found the app was instead sharing this data with marketing and analytics firms, including Facebook and Google. Flo ultimately settled with the FTC, but the app refused to admit any wrongdoing.

FTC Commissioners Rohit Chopra and Rebecca Kelly Slaughter issued a joint statement following the settlement stating that, in addition to misleading consumers, they believed the app also violated the FTC’s Health Breach Notification Rule (“Rule”), which requires “vendors of unsecured health information . . . to notify users and the FTC if there has been an unauthorized disclosure.” The FTC refused to apply the Rule against Flo as such enforcement would have been “novel.” Such disclosures will help users navigate the post-Dobbs digital landscape, especially in light of news reports that law enforcement in certain states has begun to issue search warrants and subpoenas in abortion cases.

There is additional concern regarding femtech app’s potential location tracking falling into the hands of data brokers. The FTC recently charged Kochava, a data brokerage firm, with unfair trade practice under Section 5 of the FTCA for selling consumers’ precise geolocation data at abortion clinics. While Kochava’s data is not linked to femtech, in light of the FTC’s settlement with Flo, concerns of sensitive reproductive health data from femtech apps being sold is not out of the realm of possibility. Despite the FTC announcement on exploring new rules for commercial surveillance and lax data security, experts have expressed concern on whether such rulemaking is best done through the FTC or Congress. This is because the FTC’s rules are “typically more changeable than a law passed by Congress.”

As noted, most femtech apps are not covered under HIPAA nor are they required to comply. HIPAA encompasses three main rules under Title II: the Security Rule, the Privacy Rule, and the Breach Notification Rule. HIPAA is not a privacy bill, but it has grown to “provide expansive privacy protections for [protected health information] (“PHI”).” Due to the narrow definition of covered entity, there is little protection that can be provided to femtech app users under the current structure of HIPAA even though these apps collect health data that is “individually identifiable.”    

Momentum for HIPAA to be amended so femtech may fall within the scope of covered entities may still fall short since HIPAA’s Privacy Rule permits covered entities to disclose protected health information (“PHI”) for law enforcement purposes through a subpoena or court-ordered warrant. While it does not require covered entities to disclose PHI, this permission could be troublesome in states hostile to abortion. Even if HIPAA’s definition of covered entities is expanded, it would still be up to the company to decide whether to disclose PHI to law enforcement. Some femtech companies, though, may be more willing to protect user data and have already begun to do so.

Future Outlook and What Apps Are Doing Post-Dobbs

In September 2022, Flo announced in an email to users that it was moving its data controller from the United States to the United Kingdom. The company wrote that this change meant their “data is handled subject to the UK Data Protection Act and the [General Data Protection Regulation].” Their privacy policy makes it clear that, despite this change, personal data collected is transferred and processed in the United States where it is governed by United States law. While Flo does not sell identifiable user health data to third parties, the company’s privacy policy states it may still share user’s personal data “in response to subpoenas, court orders or legal processes . . . .” While the GDPR is one of the strongest international data privacy laws, it still does not provide United States users with much protection.

In the same update, Flo introduced “anonymous mode” letting users access the app without providing their name, email, or any technical identifiers. Flo said this decision was made “in an effort to further protect sensitive reproductive health information in a post-Roe America.” The FTC, however, states that claims of anonymized data are often deceptive and that the data is easily traceable. Users may still be at risk of potentially having their sensitive health data handed over to law enforcement. Further, research shows femtech apps often have significant shortcomings with respect to making privacy policies easy to read and that users are often unaware of what their consent means.     

 While femtech has the potential to provide much-needed attention to a group often under-researched and underrepresented in medicine, the need to enhance current data privacy standards should be at the forefront for developers, legislators, and regulators. Although femtech companies may be incentivized to sell sensitive health data, their resources may be better spent lobbying for the passage of legislation like the American Data Privacy and Protection Act (“ADPPA”) and My Body, My Data Act otherwise the lack of data privacy measures may turn users away from femtech altogether. While no current reports show that menstruating individuals are turning away from femtech apps, it may be too soon to tell the effects post-Dobbs.

 The ADPPA is a bipartisan bill that would be the “first comprehensive information privacy legislation” and would charge the FTC with the authority to administer the Act. The ADPPA would regulate “sensitive covered data” including “any information that describes or reveals the past, present, or future physical health, mental health, disability, diagnosis, or healthcare condition or treatment of an individual” as well as “precise geolocation information.” ADPAA’s scope would extend beyond covered providers as defined by HIPAA and would encompass femtech apps. The ADPPA would reduce the amount of data available through commercial sources that is available to law enforcement and give consumers more rights to control their data. The Act, however, is not perfect, and some legislators have argued that it would make it more difficult for individuals to bring forth claims against privacy violations. While it is unlikely that Congress will pass or consider ADPAA before it convenes in January 2023, it marks a start to long-awaited federal privacy law discussions.

 On a state level, California moved quickly to enact two bills that would strengthen privacy protections for individuals seeking abortion, including prohibiting cooperation with out-of-state law enforcement regardless of whether the individual is a California resident. Although California is working to become an abortion safe haven, abortion access is costly and individuals most impacted by the Supreme Court’s decision will likely not be able to fund trips to the state to take advantage of the strong privacy laws.

As menstruating individuals continue to navigate the post-Dobbs landscape, transparency from femtech companies should be provided to consumers with regard to how their reproductive health data is being collected and how it may be shared, especially when it comes to a growing healthcare service that individuals are exploring online ­- abortion pills.

Angela Petkovic is a second-year law student at Northwestern Pritzker School of Law.