The A, B, Cs (along with CDCs and FDAs) of Regulatory Implications over Assisted Reproductive Technology

While attempts at IVF date back to the 1890s with the first reported case of an embryo transfer⁴ in rabbits, the birth (pun intended) of IVF occurred in 1978 in the United Kingdom, where Lesley Brown and her husband, John, had failed to conceive after attempting pregnancy for nine years. Without conducting any type of egg stimulation, Lesley underwent laparoscopic egg retrieval.⁵ British physiologist Robert Geoffrey Edwards took John’s sperm and fertilized the retrieved egg in the lab. A few days later, an eight-cell stage embryo was transferred inside Lesley’s uterine cavity. At 11:47 p.m. on July 25, 1978, 5 lb. 12 oz. Louise Brown, who was then called a “test tube baby,” was safely delivered by cesarean section. By the birth of Louise Brown, the world celebrated what was once an in-“conceivable” feat. A new era of assisted human reproductive technology has now contributed to more than five million babies conceived through IVF around the world.

Typical Medical Procedures Involved in ART and Traditional vs. Gestational Surrogacy

Common ART medical procedures aiding in pregnancy include (1) intrauterine insemination (IUI), a form of artificial insemination, in which the sperm is transferred via a medical device directly in a woman’s uterus around the time of ovulation, and (2) the most common form of ART, in vitro fertilization (IVF), in which the egg and sperm are fertilized outside the body in a laboratory and the resulting embryo(s) is/are transferred to a woman’s uterus.

Traditional surrogacy, which is often akin to a form of adoption as it allows the birth mother a period of time to change her mind and keep the child, means the surrogate uses her own egg in the conception of the child. Traditional surrogacy was most notably raised in the media in the early 1980s with the case In the Matter of Baby M.⁶ In Baby M, a traditional surrogate, Mary Beth Whitehead, fled New Jersey with the baby she was carrying for William and Elizabeth Stern and challenged the intended parents’ parental rights, wanting to keep the child. The child was conceived through insemination with the sperm of William Stern and the egg of Mary Beth Whitehead, the traditional surrogate.  The New Jersey Superior Court initially ruled in favor of the Sterns; however, following lengthy litigation, the Supreme Court of New Jersey found the surrogacy contract to be unenforceable and ordered the Family Court to determine legal custody of the child. Ultimately the Sterns were awarded custody of the child with visitation rights granted to Mary Beth Whitehead.

In contrast to traditional surrogacy, gestational surrogacy means the surrogate has no genetic connection to the child. The arrival of IVF meant an embryo with absolutely no genetic connection to the surrogate could be transferred into the surrogate’s uterus, effectively eliminating, in many cases, the surrogate’s ability to retain parental rights to the resulting child. The genetics for the embryo transferred into a surrogate can be a variety of combinations, including the genetics of both members of the intended parents,⁷ or the use of a donor egg, donor sperm, or donor embryo (with both the egg and sperm donated). The seminal case acknowledging gestational surrogacy was Johnson v. Calvert⁸ where the Court upheld surrogacy contracts as enforceable in the case of gestational surrogacy (the facts involved the parents’ egg/sperm transferred into a surrogate who had no genetic connection to the resulting child). Within the case’s concurring opinion:

Surrogacy contracts touch upon one of the most, if not the most, sensitive subjects of human endeavor. Not only does the birth of a new generation perpetuate our species, it allows every parent to contribute, both genetically and socially, to our collective understanding of what it means to be human. Every child also offers the opportunity of a unique lifetime relationship, potentially more satisfying and fulfilling than any other pursuit.⁹

Laws that Regulate ART

ART is governed by state law, and the ART legal landscape in the United States varies across the country. The law is also rapidly changing. Each state has different laws regarding surrogacy and other ART forms like egg donation (i.e. California,¹⁰ Florida¹¹ and Illinois¹²  have a legal framework for surrogacy, Georgia has no surrogacy statutes and is governed by case law and in New York it is a criminal offense to compensate a surrogate (with pending legislation to change)).  Determining the applicable state law to apply to ART requires consultation with an ART legal practitioner to determine whether the process is permissible, considering that many times the intended parents may be located in one state (or country), the surrogate in another state and the fertility clinic in a different state, as well. State law also provides regulation over medical and legal licensing requirements, continuing medical and legal education, and discipline for medical and legal misconduct regarding ART professionals.

Constitutional principles also impact the ART legal landscape. Pursuant to the ABA Guide,¹³ the major right relates to the surrogate’s right to make decisions as they relate to her body — the constitutional right under the 14^th Amendment of the Constitution and Supreme Court cases to bodily autonomy. Even if a gestational surrogacy contract provides that the surrogate will terminate the pregnancy if a doctor determines there is a genetic abnormality or other problem, the gestational surrogate has the right under the Constitution to change her mind based on the constitutional right to her body, and the only remedy the intended parents may have is to recover the money paid to the gestational surrogate and any third parties (which may be difficult to get back). The intended parents cannot force a gestational surrogate to terminate the pregnancy, and the intended parents will need to accept custody of the child regardless of any impairment.

Other constitutional principles that arise in the ART context include the right to procreate stemming from Supreme Court cases and the Full Faith and Credit Clause.  In V.L. v. E.L.,¹⁴ a same-sex female couple sought for the non-biological mother to adopt their child in Georgia before the couple eventually separated while living in Alabama. The biological mother argued that Alabama should not recognize the Georgia adoption order.  The case made it to the Supreme Court, which held that: “With respect to judgments, ‘the full faith and credit obligation is exacting…. A final judgment in one State, if rendered by a court with adjudicatory authority over the subject matter and persons governed by the judgment, qualifies for recognition throughout the land.’ A State may not disregard the judgment of a sister State because it disagrees with the reasoning underlying the judgment or deems it to be wrong on the merits.”¹⁵

With many international intended parents coming to the United States to have children via surrogacy, international laws must also be considered to ensure that the intended parents will not have difficulties returning home with their child(ren) once born in the United States. U.S. laws and policies may also affect parents who are not American citizens. For example, under the Department of State (DOS) interpretation of policy Section 301 of the Immigration and Nationality Act, children born to same-sex couples are treated the same way as children born out of wedlock for purposes of determining United States citizenship.  Despite the legalization of same sex marriage at the federal level, the DOS requires a biological father to show a blood relationship by clear and convincing evidence and meet a five-year residency requirement. This policy is currently being challenged. In E.J. and A.J. Dvash-Banks v. Pompeo,¹⁶ a unique outcome occurred where twin brothers were born via surrogacy in Canada and one child received a U.S. passport but the other was denied a U.S. passport due to the different genetics of the children and the citizenship of the parents. The parents are a same-sex male couple. One child was created by the sperm of a U.S. citizen, and one child was created by the sperm of the parent who was not a U.S. citizen. Despite the fact that the couple was married, they were treated as if their children were born "out of wedlock" which triggered different residency requirements to issue a U.S. Passport. This decision was challenged in a California court, which ruled that both children acquired U.S. citizenship at birth and ordered DOS to issue the second brother a U.S. passport. The DOS appealed the ruling to the U.S. Court of Appeals for the Ninth Circuit to determine whether both children should be issued a U.S. passport.¹⁷

Other Regulations/Stakeholders in ART

The American Society for Reproductive Medicine (ASRM), an organization further described below, asserted that “[a]fter examination of the complex network of state and federal regulation as well as professional self-regulation governing ART practice, we conclude that Assisted Reproductive Technologies are among the most regulated medical procedures in the United States.”¹⁸

Federal agencies involved with the ART industry include, but are not limited to: (1) the Centers for Disease Control and Prevention (CDC), which collects ART cycle data, publishes an annual report and develops a model program for the certification of IVF laboratories; (2) the Food and Drug Administration (FDA), providing regulation of drugs, biological products, and medical devices, screening and testing of donor tissues (since ART involves handling of human tissue), and requiring mandatory registration of all ART medical programs with the federal government; (3) the Clinical Laboratory Improvement Act (CLIA), implemented by the Centers for Medicare & Medicaid Services (CMS) which ensures quality over IVF clinic laboratories via laboratory inspections and accreditation; and (4) the American Association of Tissue Banks (AATB), which provides screening guidelines for donors of embryos and genetic material.

Some important partners who represent consumers of ART and provide infertility services such as advocacy, funding and education include RESOLVE, Path 2 Parenthood, and Livestrong Fertility.  These organizations work in partnership with the CDC.

The ART industry also has self-regulatory organizations which establish guidelines, recommend best practices, provide educational opportunities, and issue ethical opinions for professionals in the ART community as seen in organizations such as ASRM and the ASRM affiliate, Society for Assisted Reproductive Technology (SART).

Recent Expansion of ART

Typically the more standard treatments and procedures aimed at achieving pregnancy, such as IVF or surrogacy, are what come to mind when thinking about ART.  However, the scope of ART has become much broader.  Since its inception, ART has grown into a multi-billion-dollar market, and the field is only continuing to expand with emerging scientific and technological advancements.

In 2016, the global ART market was valued at $21.9 billion, and is projected to reach over $36.7 billion by 2025.¹⁹  In the past three years alone, an estimated $1 billion has been poured into women’s health technology, known as “femtech” – which is one of the largest and most accessible forms of ART.²⁰  Femtech includes period and fertility tracking apps, such as Clue and Glow, the Fitbit app’s “female health tracking” feature, which tracks period and ovulation data, as well as NextGen Jane’s “smart tampon,” which is used to detect early signs of disease that may affect women’s fertility and overall reproductive health.

Beyond the femtech sphere, scientific advances have greatly expanded the possibilities of ART.  For example, advances made with CRISPR-Cas9, popularly referred to as “CRISPR,” create the potential to use genetic engineering to modify the genetic makeup of an embryo and create so-called “designer babies.”  Commercial DNA tests can be used to track sperm donors and confirm paternity.  Posthumous reproduction can be used to create life after death by using frozen sperm, eggs or embryos, and uterine transplants can be used to treat infertility by replacing an absent or diseased uterus with a healthy one.  In addition, companies such as CiceroDx and Juneau Biosciences have created advanced non-invasive diagnostic testing for endometriosis, a common cause of infertility.²¹  The capabilities of ART will only continue to grow.

Issues with Period and Fertility Tracking Apps

The most widespread and accessible form of femtech ART is period and fertility tracking apps.  In a 2018 study of 1,000 women, approximately one quarter (23.1 percent) reported currently using or had used in the recent past a fertility app, and 76.9 percent reported their intention to use one in the future.²²  In fact, period and fertility tracking apps are the fourth most popular type of mobile app among adults, and second most popular among adolescent women.²³ These apps are incredibly useful for users as they capture information regarding, among other things, women’s menstrual cycle, sexual activity, pregnancy status and miscarriages in order to give users more insight into their fertility.  Some apps even allow women to share personal stories about their fertility journeys on forums within the app.  By allowing users to closely monitor their reproductive health in a way that was never possible before, these fertility and period tracking apps allow for more effective and efficient family planning.

Beyond the benefits to the user, the data collected by tracking apps offer great opportunities to advance ART and reproductive health.  The data collected through these apps provide companies with the potential to derive financial value from the data and present new treatment options.²⁴

However, the accuracy of these apps has been questioned, considering very few of them undergo scientific testing to ensure their accuracy.  There are approximately 100 period and fertility tracking apps that currently exist on the market.²⁵  A recent study found that only 30 of these apps purport to predict fertile days for a user, and only six of those 30 apps were found to accurately identify the fertile window.²⁶  One of these apps, the Swedish-made contraceptive device Natural Cycles, recently came under criticism after several users became pregnant while using it.²⁷ While Natural Cycles was under investigation for these pregnancy reports, the FDA authorized the marketing of Natural Cycles, making it the first, and as of now, only, app of its kind to be approved by the FDA.²⁸

In addition to accuracy concerns, there are other barriers that currently stand in the way of these apps achieving their full potential.  First, evidence shows that many of these apps are still designed and produced by men, and as a result, these apps often do not acknowledge or even completely misinterpret the full range of women’s needs, sometimes having serious repercussions.²⁹  Second, the tracking apps and other femtech have historically struggled to receive venture capital funding.  The lack of funding may be attributed to the abundance of male investors (which account for approximately 94 percent of the decision makers in the U.S. venture capital market), who may struggle to understand the health needs of women and the value proposition of women-oriented products.³⁰  Third, less research has been done to understand the use of fertility apps as a form of contraception, and their efficacy in such prevention.  In hopes to provide clarity on the matter, the FDA released a Digital Health Innovation Action Plan,³¹ which looks at ways in which the agency regulates digital health technologies such as the FDA-approved Natural Cycles app.³²  Fourth, as further discussed below, privacy concerns are prevalent, considering the wide scope of data sharing that occurs through these apps.

Rising Privacy and Cybersecurity Implications with Emerging Femtech ART

Using fertility apps and other forms of femtech ART require the user to share a tremendous amount of information, much of it sensitive and private.  And with such data, there is a growing concern as to how individuals’ privacy is being protected.  While an immense amount of individually identifiable health information is shared with emerging femtech ART, there are currently minimal regulations and protections with respect to such data sharing.  There is a common misconception that ART applications and other femtech are regulated by the Health Insurance Portability and Accountability Act of 1996³³ (HIPAA) regulations, because they encompass health data, but this is often not the case.  What HIPAA does cover are “covered entities,” which include health plans, health care clearinghouses, health care providers that perform certain types of electronic transactions, and their vendors or “business associates.”  However, many ART research organizations and clinics, as well as femtech and mobile app developers working on ART solutions, are not directly subject to HIPAA’s privacy and security standards.  Instead, they are often left to implement security measures and safeguards in line with industry standards or as they deem reasonable, leading to inconsistencies and vulnerabilities in the protection of personal data.  For example, in 2016 Consumer Reports tested Glow, a mobile app designed to help women track their period and fertility, for security and privacy features.  What Consumer Reports found was alarming – one security flaw would have allowed a person with no hacking skills to access a women’s personal data, while other flaws would have allowed a hacker to collect email addresses, change passwords, and access personal information from participants in community forums.³⁴  Glow quickly updated the app to patch the security issues and notified customers of the issue, and indicated that no customer data had been compromised.³⁵

Another example of a security vulnerability is the lack of transparency with respect to data sharing with third parties.  In 2019, the Wall Street Journal found that a number of popular healthcare apps share personal and health data with Facebook.³⁶  In particular, it found that the Flo Period & Ovulation Tracker shared with Facebook information on when a user was having her period.  In addition, UK-based advocacy group Privacy International discovered that tracker apps, including MIA Fem and Maya, were sending personal information about women’s health and sexual practices directly to Facebook.³⁷  Privacy International concluded that out of the 36 apps it tested, 61 percent automatically transfer data to Facebook the moment a user opens the app, regardless of whether the user was logged into Facebook or had an account.³⁸  So, while data from tracking apps and other femtech can provide companies with financial value, companies will also need to consider the marketing and overall transparency requirements under the FDA and the Federal Trade Commission (FTC).³⁹

There are also other laws and regulations that may apply to ART, which may ultimately cause potential confusion for ART providers and consumers and inconsistency within the field.  Many states are implementing new privacy laws that go beyond the scope of HIPAA, such as the California Consumer Privacy Act (CCPA), which has a particularly broad definition of what constitutes “personal” data, and has heightened security and privacy requirements.⁴⁰  For example, the CCPA and HIPAA articulate different standards for de-identified data.⁴¹  In addition, several states have either enacted legislation or have pending privacy bills, which contain varying obligations with respect to prior consent when collecting or sharing consumer data.⁴²  Therefore, with the increasing prevalence and severity of data breaches, and with new privacy laws going into effect that require reasonable security measures and greater consumer data rights, ART providers, researchers, and apps will need to address the privacy and security implications of collecting and storing consumer data. 

Conclusion

ART is a dynamic and rapidly evolving field, with new technologies continually creating new capabilities and opportunities.  While giving hope to millions of couples experiencing infertility, ART has also introduced new social and legal questions.  As a result, the regulatory implications continue to evolve to accommodate and respond to these unique questions created by ART.

This article is based on a presentation given by Kimberly Gold, Marla Neufeld and Dr. Sharon Jaffe at the 20th Annual Conference on Emerging Issues in Healthcare Law, “Third Party Assisted Reproduction and Health Law Implications,” ABA Health Law Section, March 13-16, 2019, Orlando, Florida.

1. https://www.hhs.gov/opa/reproductive-health/fact-sheets/female-infertility/index.html.
2. “Assisted Productive Technology” means procreative procedures which involve the laboratory handling of human eggs, sperm or embryos. 
3. “Third Party ART” means human reproduction in which genetic material or gestation is provided by a third party, other than the person/people intending to raise the child (i.e. egg donation or surrogacy).
4. “Embryo transfer” means the medical procedure of transferring embryos into intended mother/surrogate.
5. “Retrieval” means the medical procedure of surgically removing eggs from an egg donor.
6. In the Matter of Baby M., 109 N.J. 396 (1988).
7. “Intended parents,” or a “commissioning couple,” means the parent(s) intending to have a child(ren) conceived by means of ART.
8. Johnson v. Calvert, 5 Cal.4th 84, 19 Cal.Rptr.2d 494; 851 P.2d 776, (1993).
9. Johnson v. Calvert,  5 Cal.4th at 101-201.
10. California Code, Family Code - FAM § 7962.
11. Florida Statutes 742.15.
12. (750 ILCS 47/) Gestational Surrogacy Act.
13. Marla Neufeld, Esq. and Jeffrey Kasky, Esq. in the American Bar Association’s Guide to Assisted Reproduction: Techniques, Legal Issues, and Pathways to Success.  For more information, see https://www.americanbar.org/products/inv/book/255155404/.
14. V.L. v. E.L., 136 S. Ct. 1017 (2016).
15. Id. at 1020.
16. Dvash-Banks v. Pompeo, No. CV 18-523-JFW(JCX), 2019 WL 911799 (C.D. Cal. Feb. 21, 2019).
17. Dvash-Banks v. U.S. Dep’t of State , No. 19-55517, 2019 WL 5296486 (9th Cir. October 11, 2019).
18. https://www.asrm.org/about-us/media-and-public-affairs/public-affairs/oversight-of-assisted-reproductive-technology/.
19. https://medium.com/@prathod.qbi/assisted-reproductive-technology-market-to-grow-with-cagr-of-6-and-expected-to-reach-36-7-93274460098d.
20. https://medicalfuturist.com/femtech-womens-health/.
21. https://www.biospace.com/article/new-test-brings-hope-and-new-answers-for-unexplained-infertility-failed-ivf-and-miscarriage/?utm_campaign=GenePool&utm_source=hs_email&utm_medium=email&utm_content=76996169&_hsenc=p2ANqtz-9AgBOzCk6c0M74aKdH_NF8qlxRCZACoD8xaIyT_kTivexNy2mVCXKLSrRlH0obCYn6GgCHlf9YnhyRLG5bM0OyLBrTg&_hsmi=76996169.
22. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043758/.
23. https://www.vox.com/the-goods/2018/11/13/18079458/menstrual-tracking-surveillance-glow-clue-apple-health.
24. https://www.bloomberg.com/news/articles/2019-01-24/how-period-tracking-apps-are-monetizing-women-s-extremely-personal-data.
25. https://time.com/5365564/fertility-apps-contraception/; https://www.cnbc.com/2018/10/13/fertility-apps-are-one-the-rise-and-natural-cycles-is-now-fda-approved.html.
26. Duane, M., et al., The Performance of Fertility Awareness-based Method Apps Marketed to Avoid Pregnancy, 29 The Journal of the American Board of Family Medicine 4 (2016).
27. https://www.businessinsider.com/birth-control-app-problems-natural-cycles-2018-1.
28. The Natural Cycles app was cleared by the FDA under a process specifically designed for new types of medical devices called De Novo classification. Along with this authorization, the FDA is establishing criteria, called special controls, in hopes to clarify the agency’s expectations in assuring the accuracy, reliability and effectiveness of these apps as a form of contraception. https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-app-contraceptive-use-prevent-pregnancy.
29. https://www.vox.com/the-goods/2018/11/13/18079458/menstrual-tracking-surveillance-glow-clue-apple-health.
30. https://www.lexology.com/blog/2019/05/the-future-is-femtech.
31. In September 2019, the FDA provided new guidance to continue the efforts outlined in the Digital Health Innovation Action Plan and to offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies. Initial guidance topics include clinical decision support software and changes in medical software policies resulting from Section 3060 of the 21^st Century Cures Act. https://www.fda.gov/news-events/press-announcements/statement-new-steps-advance-digital-health-policies-encourage-innovation-and-enable-efficient-and.
32. https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-app-contraceptive-use-prevent-pregnancy.
33. 45 C.F.R. Part 160, Part 162, and Part 164.
34. https://www.consumerreports.org/mobile-security-software/glow-pregnancy-app-exposed-women-to-privacy-threats/.
35. https://www.consumerreports.org/mobile-security-software/glow-pregnancy-app-exposed-women-to-privacy-threats/; https://www.consumerreports.org/mobile-security-software/glow-pregnancy-app-exposed-women-to-privacy-threats/.
36. https://www.wsj.com/articles/you-give-apps-sensitive-personal-information-then-they-tell-facebook-11550851636?mod=article_inline.
37. https://www.buzzfeednews.com/article/meghara/period-tracker-apps-facebook-maya-mia-fem.
38. https://www.privacyinternational.org/long-read/3196/no-bodys-business-mine-how-menstruation-apps-are-sharing-your-data.
39. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/internetsocial-media-platforms-character-space-limitations-presenting-risk-and-benefit-information; https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing/advertising-and-marketing-basics.
40. AB375, Title 1.81.5, The California Consumer Privacy Act of 2018.  The CCPA is designed to protect the privacy and data of consumers. The Act requires businesses to tell consumers what data it is collecting and gives consumers the right to say no to the sale of their personal information. It will also allow consumers to sue companies in the event their personal data is breached.
41. https://www.natlawreview.com/article/health-sector-does-not-completely-avoid-ccpa-hipaa-exemption.
42. For example, California, Maine and Nevada enacted privacy legislation with varying consent and notice requirements, while nearly 10 other states have privacy bills pending in committees.  https://iapp.org/news/a/us-state-comprehensive-privacy-law-comparison/.

About the Authors

Kimberly Gold, Esq. is a partner at Reed Smith and her practice focuses on data privacy, cybersecurity, and digital health matters. She advises clients in the life sciences and healthcare industries on privacy compliance, research and big data initiatives, complex transactions (including mergers and acquisitions, private equity, and technology transactions), government investigations, corporate governance, and cybersecurity incident planning and response.  She may be reached at [email protected].

Marla Neufeld, Esq. is a partner in Greenspoon Marder’s Surrogacy and Assisted Reproductive Technology practice group, which she founded, and represents parties using a surrogate or egg, sperm or embryo donor. Ms. Neufeld was personally part of the statistic of one of every eight couples of childbearing age struggling with infertility and utilizes her own experience with her fertility-related legal practice. She experienced her own infertility journey for over four years and ultimately used a gestational surrogate to build her own family. She also co-authored a book published by the American Bar Association titled The ABA Guide to Assisted Reproduction: Techniques, Legal Issues and Pathways to Success. She may be reached at [email protected].