Innovation and Women’s Health CULTURAL, MEDICAL AND LEGAL PERSPECTIVES

Authors: Tamar Tavory, Adv., LLM, Special Counsel, Yigal Arnon & Co. Itamar Netzer, MD, MBA, OB/GYN, Healthtech Consultant

- 1 - Photo by Daria Shevtsova contents

3 Introduction

4 Part 1 - Gender In Medicine Technological Innovation 7 Affecting Women’s Health

Part 2 - The Unseen 10 Barriers

11 The Legal Framework

11 Taboos and Educational Disparities

12 Gender Bias in the Media Gender Bias in Artificial 13 Intelligence

Part 3 - Promoting Women’s Health With 15 Digital Health Tools - Challenges and Concerns

16 Women’s Health Data in the Information Age Why Are We Collecting these 16 Data – Intimate Surveillance Data Collection’s Effect on 17 Healthcare Provider–Patient Relationship Protection of Data - the Legal 18 Framework

Part 4 -The Social Stance of Femtech Companies 21 and a Business Ethical Code

- 2 - This article is meant to provide general information only. It does not constitute legal advice or legal opinion and cannot be relied on as such. Likewise, this article does not constitute medical advice or medical opinion and cannot be relied on as such.

- 3 - INTRODUCTION

This article aims to serve entrepreneurs and investors to better understand the market, women's health needs, the obstacles to success and some of the means to overcome them, as well as some future issues that may affect this industry. In particular, it may assist the industry by translating some components of the physician-patient relationship, specifically confidentiality and trust, into practical advice for Femtech products.

echnology focused on women’s and gynecological issues and they might Tfemale health needs is digital health’s view women’s health needs as “luxury” sparkling promise. Estimated to reach $50 rather than as substantial problems. The billion by 20251, and touching the lives difficulties Femtech companies have in of 50% of the population – Femtech and raising funds due to these perceptions are women’s health seems to embody great well known in the industry2. Ventures in potential for profit and positive impact. the general Healthtech space, even if not This article attempts to take an in-depth focusing on women in particular, may find look at technologies for women’s health, it useful to consider the special aspects of using historical, clinical, medical, cultural women’s health needs and technology, and and legal perspectives. We believe that this thereby identify a broader market for their will serve entrepreneurs, developers and products. investors to better understand the market, It is important to note that these women’s health needs, the obstacles to difficulties have deep legal, social and success, some of the means to overcome cultural roots. The first part of this article Tamar Tavory Adv. them, and some future issues that may describes the historical development LLM, Special Counsel, affect this industry. of women’s health in the medical field Yigal Arnon & Co. The term Femtech is attributed to Ida Tin, and how it was systematically neglected. co-founder of the Clue menstrual tracking It also describes the development of app, in 2016. This term signifies medical and technological solutions to feminine wellness technologies targeting women or needs and their contribution to women’s the unique needs of women. In this article liberation. The second part deals with we address not only companies that refer the hurdles Femtech companies face as to themselves as “Femtech”, but also any they are affected by the legal regulation company that develops technology aimed of women’s healthcare, social norms and at improving women’s health – regardless taboos tied to that area, and gender bias of their name. – be it an artificial intelligence algorithm deployed in healthcare, or the media where The Femtech industry is unique, not they publish. These obstacles need to be because it is comprised mostly of women identified and addressed. The third part CEOs and founders (as it is), but because of the article focuses on the data as the of its sincerity. It is an industry that was main component of Femtech solutions founded to provide medical solutions to and its unique challenges to women’s Itamar Netzer MD MBA problems that are so mundane, that women healthcare. It describes the information OB/GYN, Healthtech Consultant have been aware of them for centuries; and revolution’s effect on the patients and yet have remained hitherto unsolved. In the price tag attached to it, its effect on addition, it deals with an area of medicine medical treatment, and also the regulatory that is especially sensitive, pertaining as it scheme for privacy in medical data and its does to taboos, cultural norms and personal drawbacks. predilections, and generating information that if exposed to the outside world would In conclusion, this article proposes a not only be embarrassing, but might also voluntary ethical code for future Femtech cause harm. companies. In many ways, this ethical code is already in existence though unwritten, Investors, mostly men, might find it and is implemented by most of the Femtech hard to relate to this area of experience. companies researched for this paper. They might be too embarrassed to discuss

1 https://www.forbes.com/sites/estrellajaramillo/2019/12/17/Femtech-in-2019-trends-investment-in-womens-health-technology/#42d195e0114c (estimated for 2025 by F&S) 2 “We need to talk about investors’ problem with vaginas”, https://www.wired.co.uk/article/vagina-pitches-vcs-sexism - 4 - PART 1 Innovation and Women’s Health GENDER IN MEDICINE

That women and men should have equal rights, regardless of their physiological differences, is no news to most people. Perhaps unsurprisingly, the medical profession has only in recent years become aware of both the clinical significance of these differences, and the disparity that exists in medical services that different genders require and receive.

In recent years, subcurrents of both medical and technological movements have begun changing direction to rectify these disparities. This article refers mainly to Gender Medicine, which addresses physiological differences and the underrepresentation of women in clinical research; and Femtech, the branch of Healthtech that addresses women and their needs as its primary customers.

- 5 - PART 1 GENDER IN MEDICINE

Much like other fields of human focused mostly on reproduction – sport of nature you have observed endeavor, medicine and medical contraception, birth, and in some in some women, and you can hardly science have been dominated mainly instances even problems that still ascribe this new and useless part, as if by men for most of the known history challenge modern gynecology. The it were an organ, to healthy women.” of Western civilization. Women who Kahun Papyrus (circa 1850 BC) and He concluded, “I think that such a made it through were so few and far Ebers Papyrus (circa 1550 BC) of ancient structure appears in hermaphrodites between, that for the more prominent Egypt mention uterine prolapse, and who otherwise have well-formed ones among them, their identities suggest it should be treated with a genitals, as Paul of Aegina describes, are household names, such as Marie pessary of petroleum and manure; but I have never once seen in any Curie or Florence Nightingale. Others, while Hippocrates (460-377 BC) woman a penis or even the rudiments like Angelique Marguerite Le Boursier suggested either pessaries of vinegar of a tiny phallus7.” Notably, the du Coudray3 - an 18th century soaked sponges, or pomegranate full anatomy of the clitoris and its French midwife, inventor of the birth halves, or hanging women with relationship to other parts of the simulator and author of that era’s most their legs up to reduce the prolapsed genitalia was only detailed in the late knowledgeable obstetrics manual, uterus4. In contrast, “Hysteria” was 20th century, by O’Connel et al in Abrégé de l’art des Accouchements - known to the ancient Greeks as a 19988. are less famous, but left long lasting disease caused by movement of the Anatomical squabbles and neglect legacies. Her “Machine” (Figure 1) is uterus (hyster) around the body, aside, important aspects of female not only the first obstetric medical causing great psychological stress; medicine were deemed too base or simulator built, but probably the and yet up to and including the 19th taboo to warrant the attention of first anatomically correct medical century, the concept of Hysteria was physicians, and as such birth was simulator in history. It has impacted still being used by Freud and his the sole responsibility of midwives, the lives and well-being of countless contemporaries5. until it was incorporated back into women in her generation and ever In other areas of medicine, medicine in the 17th century and since. And yet perhaps unlike other anatomists squabbled for centuries midwives became excluded from the areas of science and art, the male on the nuances of female anatomy, conversation. Birth has seen both dominance of medicine affected not often discovering, quashing, and sides of a pendulum, disregarding the only the identity and opportunities rediscovering the clitoris. Notably, needs of women at both ends. From of its practitioners, but created a in 16th century Italy, the clitoris the dangers of birth before modern bias in the very basis of its practice was “discovered” by Matteo Renaldo medicine and in today’s developing and knowledge. It wasn’t until the Colombo (and named “The love or countries, and the high rates of 20th century that women began to sweetness of Venus”, amor Veneris, maternal death, to overmedicalization participate in the medical profession, vel dulcedo)6. This was disputed by and the “assembly line” mentality of slowly leading to a process of increased his student Gabriele Falloppio, who some delivery rooms and maternity equality. claimed to have discovered it first, and wards, and an arguably excessive level Before the advent of the scientific both were ridiculed by the famous of medical intervention. method, medicine was limited in its anatomist Vesalius, who stated: “It Modern medicine begins to refer abilities and its understanding of the is unreasonable to blame others for to some differences between men and human body. Medicine for women incompetence on the basis of some

3 https://www.medarus.org/Medecins/MedecinsTextes/du_coudray.htm (French) 4 Reisman, Y., Porst H., Lowenstein L., Tripodi F., Kiana P.S. (editors): The ESSM Manual of Sexual Medicine. 1st and 2nd Editions. 5 Hysteria R.E. Kendell, in International Encyclopedia of the Social & Behavioral Sciences, 2001. 6 Neil, L.; Sigal, Pete; Chuchiak, IV, John F. (2007). Sexual Encounters/Sexual Collisions: Alternative Sexualities in Colonial Mesoamerica. Duke University Press. ISBN 978- 0822366706. 7 O'Connell, Helen E.; Sanjeevan, Kalavampara V.; Hutson, John M. (October 2005). "Anatomy of the clitoris". The Journal of Urology. 174 (4): 1189–95.doi:10.1097/01. ju.0000173639.38898.cd. PMID 16145367. S2CID 26109805. - 6 - 8 O'Connell HE, Hutson JM, Anderson CR, Plenter RJ. Anatomical relationship between urethra and clitoris. J Urol. 1998;159(6):1892-1897. GENDER IN MEDICINE “Gender bias in the healthcare system and in the medical field still has a long way to go”

women only in the late 20th Century. Health, and continued with its even denied11. Bernardine Healy’s 1991 New England pivotal 2015 decision to mandate In the U.S.A, black women’s Journal of Medicine editorial, “The consideration of sex as a biological maternal mortality rates are three to Yentl Syndrome”, marks a turning variable in all NIH funded research10. four times higher than white women’s point in this regard. In Isaac Bashevis However, correcting gender bias in the — and these deaths are mostly Singer’s story, the heroine Yentl healthcare system and in the medical preventable12. The American Academy disguises herself as a young man so field still has a long way to go. of Family Physicians explains that that she be allowed to study Jewish Moreover, gender bias is not the healthcare facilities that exclusively law. Similarly, the editorial points only shadow cast over the healthcare served racial and ethnic minorities to studies showing that women system. Women who belong to an in the past continue to operate with were significantly less likely than ethnic minority in their countries or limited resources — and, likely as a men to be treated invasively when women of color suffer from unique result of financial constraints, they admitted to hospital due to cardiac difficulties, attributed both to their tend to have higher occurrences of coronary disease. However, women gender and to their race or ethnic complications during delivery than who had already undergone cardiac origin. When approaching women’s predominantly white hospitals13. This catheterization or had a diagnosis of health, one cannot ignore the double demonstrates how systematic racism myocardial infarction did not differ bias effect. embedded in the healthcare system from men9. affects patients nowadays, long after Women belonging to minority In recent years, various sections of discriminating laws were cancelled14. groups might suffer from certain the American government including medical problems more than AMA Oncology findings show that the NIH, the FDA, and the Senate, women from the general population, black women also had higher odds of have begun to require increased and as such they require cultural being diagnosed with breast cancer at participation of female mice in adjustments to the local medical advanced stages. They concluded that animal studies, as well as increased care or have less of access to medical nearly half of the racial differences research into women’s health and treatment. In addition, women with they observed in diagnosis were the their inclusion in clinical studies. disabilities’ feminine health needs, result of limited access to health This began in 1990 when the NIH and specifically reproductive and insurance15. established of an Office for Women’s sexual health needs, are ignored or

9 https://abcnews.go.com/Health/fda-recommends-slashing-sleeping-pill-dosage-half-women/story?id=18182165 10 https://www.bbc.com/future/article/20180518-the-inequality-in-how-women-are-treated-for-pain 11 United Nations General Assembly, Note by Secretary General, Sexual and reproductive health and rights of girls and young women with disabilities 14 July 2017. 12 Holdt Somer SJ, Sinkey RG, Bryant AS. Epidemiology of racial/ethnic disparities in severe maternal morbidity and mortality. Semin Perinatol. 2017 Aug;41(5):258-265. doi: 10.1053/j.semperi.2017.04.001. PMID: 28888263. https://www.nationalpartnership.org/our-work/resources/health-care/maternity/black-womens-maternal-health-issue-brief. pdf. See also, Dr. Nataki Douglas, Let's get real about racial bias and disparities in women's health, Feb 28, 2020 accessible at: https://modernfertility.com/blog/racial-bias-dis- parities-black-womens-health/ 13 https://www.aafp.org/about/policies/all/institutional-racism.html 14 See Dr. Nataki Douglas at footnote 12 15 “Cancer Facts and Figures for African Americans 2019-2021”. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-fig- ures-for-african-americans/cancer-facts-and-figures-for-african-americans-2019-2021.pdf

- 7 - So, even when Healthtech finally first licensed for use in 1960); these begins to provide solutions to women’s have enabled women to decide if and health needs, it is important to when they wish to become pregnant, examine diversity, its ramifications on facilitating the sexual revolution. The the specific health issue concerned, prevention of unwanted or unplanned and subsequently, provide answers to pregnancies regardless of marital the medical needs of different women. status not only enables women to plan their families and careers; it also Technological Innovation Affecting protects them from the sometimes Women’s Health harmful effects of miscarriage, Technology has been a driving abortion, pregnancy or childbirth. force in enabling women to overcome • Breast pumps – although antiquated social norms and increase Gender bias is not the variations of these have existed since their participation in academia, the 19th century, even before the only shadow cast over the politics and industry. This article does existence of electric refrigerators healthcare system. Women not wish to belittle the importance of enabling milk preservation, the historical heroines of feminism who belong to an ethnic mechanical pumps were first and the social movements they led. introduced in 1923. Their significance minority in their countries However, as the following examples is in enabling women who wish to or women of color suffer illustrate, technologies designed for, breastfeed to continue to do so while and used by women had a pivotal effect from unique difficulties returning to work. Infant formula on their health and independence, (also in existence since the mid-19th attributed both to their their ability to acquire an education, century but perfected to a level almost, gender and to their race or participate in the work force, or fight but not quite, comparable with breast for their rights. These examples also ethnic origin. milk only in recent decades) has show that until recent years, there was served women in a similar fashion, little innovation in these areas. enabling them to return to work early The use of tampons is recorded after childbirth without being tied throughout history, starting with down to the home, caring for infants. the Ebers Papyrus mentioned above (detailing soft papyrus tampons used by ancient Egyptian women). The first commercial tampon was patented in 1933 by Dr. Earle Haas, and marketed under the Tampax brand name beginning in 1936. This arguably starts the drudgingly slow “race” of technologies being developed for the sake of women’s health and wellness. However, slow as the race may be, many technological developments related to women’s health have had pivotal roles in improving women’s access to education, to workforce participation and to self-fulfillment. This list includes, among other things: • Menstrual hygiene products (including tampons, pads and menstrual cups) and their liberating effect on girls and young women attending school or university, or the workplace. • Contraceptive technologies including barrier and intra-uterine devices but mostly combined hormonal contraceptives (“The Pill”, Figure 1: “The Machine” for simulating and teaching childbirth, By Angélique Marguerite Du Coudray (1715-1794).

- 8 - birth or natural birth - thus rejecting suddenly a chance for real change. the medical-technological approach The current crop of digital to childbirth and preferring a more Femtech products was heralded by The Covid-19 woman-oriented, natural approach16. menstruation or fertility tracking apps Technology served immediate medical pandemic led to but has not stopped there. Existing needs, but ignored the psychological and emergent products in Femtech the dismantling aspects as well as women’s point of include innovative contraceptive of regulatory, view in the process. solutions (both barrier-methods and psychological and However, arguably, the debate intrauterine devices); new approaches organizational might not have been possible without to hormonal therapy for menopause, barriers, and brought the medical technologies involved endometriosis or contraception; but in prenatal screening such as fetal also a wide range of new indications about an exponential heart monitors, ultrasound, genetic that can be addressed by digital increase in the use of testing and more, enabling the medicine. This includes the addition tele-health and other classification of some pregnancies as of not only passive fertility tracking but low risk, and therefore more suitable the use of wearable or other sensors; remote health care for home delivery than others. There digital solutions or data collection for tools. is still room for more fine-tuning pelvic floor prolapse, endometriosis, of this decision process through polycystic ovary syndrome, and more; digital health, as well as for at-home as well as digitally synchronized • Safe Abortions – this field monitoring technologies to truly sexual wellness devices. revolutionize home delivery. has seen a major revolution from the The Covid-19 pandemic led days of back-alley illegal abortions to The digital health era, including to the dismantling of regulatory, today’s sterile procedures, including advanced materials, wearable sensors, psychological and organizational the option for non-invasive, medical artificial intelligence and machine barriers, and brought about an abortions. Abortions have evolved learning, and digital health apps, exponential increase in the use of from being a life-threatening is giving rise to new opportunities tele-health and other remote health procedure to one that minimizes for bettering women’s health from care tools. Telehealth was used to medical risk, and can be said to avert women’s point of view, constituting support women’s health as well: some of the dangers inherent in Femtech as we have come to know it so from remote pregnancy monitoring pregnancy and childbirth in the case far. After years of slow and very little to online psychological support. A of unwanted pregnancies or those innovation in women’s health, there’s recent survey in the USA revealed that hazardous to the mother’s health. These technological innovations, although pivotal, have not undergone any major innovation in their design during the 20th century. Instead, they have undergone incremental improvements in material, shape, or dose, as the case may be. Many women’s health issues have been left unattended, or at least unchanged for many years. Main examples include, but are not limited to, endometriosis and other pelvic pain syndromes, and autoimmune diseases. In certain cases, technological development improved medical treatment, but failed to provide a full answer to women’s needs. For example, technology has mitigated some of risks of childbirth, but in recent years, many women started preferring home

16 Home birth has been controversial in some countries, and a great success in others. The transition from hospital to home births is layered with considerations of health economics, power struggles, and democratization of health care.

- 9 - 93% of patients were either satisfied or The full effect of the novel very satisfied with their telemedicine Coronavirus pandemic on women’s experience, and 92% would continue to health and the Femtech industry is use telemedicine in the future17. not entirely clear yet, but it seems safe to say that the use of medical apps, On the other hand, the pandemic wearables and telehealth supporting carries a heavy financial toll, especially women’s health will flourish. At the on women who lost their jobs and source same time, disparities are becoming of income, women who carry the burden more prevalent. Femtech technology of caring for their families and for the can come up with new solutions for elderly, pregnant women, and notably women in need, bridge over disparities on women who suffer from domestic and contribute to mitigating them, but violence, which has seen an increase it might also deepen them. during the pandemic. Additionally, women, like men in these times, tend to postpone any medical examination which is not crucial - which might lead to higher rates of diseases in the future.

17 https://metova.com/survey-high-demand-telemedicine

- 10 - PART 2 Innovation and Women’s Health THE UNSEEN BARRIERS

Technology can advance women’s health immensely. However, as will be described hereinafter, women’s health suffers from high politization, from regulators’ intervention on behalf of society’s norms and expectations, and from social taboo and low awareness in certain areas. Consequently, in order to succeed in developing Femtech solutions, unseen barriers need to be identified and addressed. In many cases, addressing such obstacles can reveal a new target market or assist in better approaching an existing market. The following are the main unseen barriers faced by Femtech companies.

- 11 - PART 2 THE UNSEEN BARRIERS

The Legal Framework services, such as abortion; the length cannot be quickly erased. In many of a paid or unpaid maternity leave cultures, menstruation, infertility, Women’s health is a highly (or its absence), and other social menopause and sexual health are politicized and heavily regulated rights for working women (e.g., breast considered topics that should not be topic. The law simultaneously acts feeding during work hours, sick leave spoken of. In many cases, healthcare as a barrier to women’s access to for pregnant women); and medical providers, teachers and parents do services, and as a tool to ensure that aid and support in cases of domestic not address these matters because of women have effective access to health violence or rape. The law, in many embarrassment and misconceptions. services18. Termination of pregnancy is ways, demonstrates how women’s a classic example: abortions in certain Menstruation, for example, is health is treated in a specific country. countries are forbidden or limited considered in certain cultures impure, by law. Some countries require a In countries where the law restricts dirty and requiring isolation or other passage of time before termination or women’s health needs or does not limitations. Menstruation and religion an ultrasound examination although actively grant women access to have a complicated relationship that there is no medical need19. The use of primary and gynaecological health is well documented. In Judaism, in emergency contraceptive pills, with care, the gap is meaningful and social biblical times, a menstruating woman or without prescription, is another disparities are more common. A was perceived as spiritually impure example. Emergency contraceptive Femtech company might be deterred and prohibited from certain temple- pills are most effective if taken within by legal gaps or restrictions or related rituals. In modern times. 24 hours after intercourse. Any delay, identify them as an opportunity for Jewish “halacha” restricts physical for example, due to a requirement action to answer unattended needs. contact between a married couple for a prescription, can impede the For example, a legal requirement during and immediately following woman’s wish to prevent pregnancy. for a prescription of emergency menstruation20. contraceptive pills can be fulfilled Examining the regulation of In India, there are traditional through a telehealth prescription women’s reproductive and sexual restrictions on girls and women of solution. health’s needs will shed more light menstruating age, such as limitations on the extent to which the law and However, some restrictions do on entering temples21, a requirement society as a whole acknowledge not derive from law and regulation, to launder beddings (even when these needs. The following legal but rather from social and cultural they are not dirty), refraining from categories need to be examined: roots. In many cases, cultural norms cooking, or eating with separate the introduction of new drugs, and social taboos as well as lack utensils and staying away from other including those used for emergency of education serve as a barrier, family members22. contraception; the coverage of preventing women from accessing Viewing menstruation as a source primary health care, gynecological much-needed healthcare solutions. of shame and embarrassment is not care, fertility treatments, ovarian Taboos and Educational Disparities limited to rural areas or to traditional cancer and breast cancer screening societies. It is interesting to note tests and drugs, and contraception Femtech is active in areas that American television started drugs in the public health system or pertaining to women’s health that using the explicit word “period” in in governmental insurance plans. for many years have been concealed, commercials only as late as 198523. Additional categories include the hidden, and linked with shame Clear signs of menstruation are often liberalization or legalization of certain and embarrassment. Such a legacy censored in social media, either by

18 R.J. Cook & C.G. Ngwena, Women’s access to health care: The legal framework, International Journal of Gynecology and Obstetrics (2006) 94, 216 - 225 19 Jen Russo, MD, MPH, "Mandated Ultrasound Prior to Abortion", AMA Journal of Ethics, April 2014. https://journalofethics.ama-assn.org/article/mandated-ultrasound-prior-abor- tion/2014-04 20 For a thorough analysis of menstruation in Judaism and Hinduism, see Ilana Cohen, “Menstruation and religion: developing a critical menstruation studies approach," in The Palgrave Handbook of Critical Menstruation Studies, Ed. Bobel, Winkler, Fahs, Hasson, Kissling, Roberts, at p 115. 21 See Indian young lawyers association & others v. the state of kerala & others, S.C.C. 1[2018] India’s Supreme Court overruled a ban preventing women and girls of menstruation age from entering a temple. This precedent and the riots that broke out afterwards are described in Ilana Cohen, at footnote 20. 22 https://www.youtube.com/watch?v=qm0isl11BfY - 12 - 23 https://www.thecut.com/2015/09/great-moments-in-menstrual-history.html few organizations are working on producing low cost sanitary pads and supplying them to girls in need29. Others target the sale tax often applied to hygiene products, explaining that such basic necessities should not be taxed30. In Germany, where tampons were taxed at a higher rate than books, one company produced a “tampon book” to increase equitability (Figure 2). These and other efforts convinced the authorities to reduce taxes on feminine hygiene products. One European nation has gone even further – as the Scottish parliament recently voted to make period products free for anyone who needs them, intending to end “period poverty”31. Figure 2: “The Tampon Book” by The Female Company. Image used with permission of the company. The so-called “pink tax" does not stop in sanitary pads and tampons. Research has shown that in many cases, female- targeted products will cost more than their feminine body functions26. men's products. According to New “Women’s health suffers Such social self-restrictions and York City Department of Consumer from high politization, cultural taboos should be kept in mind Affairs’ research, on average, women’s from regulators’ when developing a solution to women’s products cost 7 percent more than needs. Femtech companies can develop similar products for men in quite a few intervention on behalf educational means to raise awareness, industries, for example: 7 percent more of society’s norms and to meet women’s health needs or to for toys and accessories, 4 percent expectations, and from offer guidance to traditional women more for children’s clothing, 8 percent who might otherwise be deterred from more for adult clothing, 13 percent social taboo” their products or services. more for personal care products and 8 percent more for senior home Gender and biological differences healthcare products32. The research the menstruating women themselves translate to financial outcome as further concludes that although there or by others. A 1996 Marathon runner’s well. Many girls cannot afford pads may be legitimate drivers behind some decision to run while menstruating and tampons, and refrain from going portion of the price discrepancies, without tampons was confronted to school during their period. A 2011 higher prices for women are mostly with great criticism24. An emoji of survey by AC Nielsen, commissioned unjustifiable. Figure 3 reveals a price menstruation has not been created by the Indian government, found that discrepancy driven by Covid-19. yet, although other bodily functions only 12% of women across India use 27 Gender Bias in the Media are represented25. Being raised with sanitary pads . According to a research such restrictions sends a clear message held in the UK in 2017, one in ten girls Another important and sometimes to girls and young women as to the does not have the means to purchase overlooked barrier is bias in the 28 shame and embarrassment linked to sanitary pads for their periods . A media: ads, commercials and today,

24 https://www.boston.com/news/omg/2015/08/10/how-boston-inspired-the-marathoner-who-skipped-a-tampon-to-teach-a-lesson 25 The lack of emoji was noted by Noga Raz Shavit in https://xnet.ynet.co.il/articles/0,7340,L-5636591,00.html “Isn’t it time to speak freely, and without being ashamed, about the period” (in Hebrew) 26 https://www.youtube.com/watch?v=qm0isl11BfY 27 https://www.bbc.com/news/magazine-26260978 28 One in ten girls cannot afford sanitary wear, survey finds, Oct 2017. https://plan-uk.org/media-centre/1-in-10-girls-have-been-unable-to-afford-sanitary-wear-survey- finds 29 https://www.freeperiods.org/mission 30 https://www.washingtonpost.com/news/wonk/wp/2016/01/08/the-tampon-tax-explained/, 31 https://www.nytimes.com/2020/11/24/world/europe/scotland-free-period-products.html 32 From Cradle to Cane: The Cost of Being a Female Consumer - A Study of Gender Pricing in New York City, 2015: https://www1.nyc.gov/assets/dca/downloads/pdf/part- ners/Study-of-Gender-Pricing-in-NYC.pdf

- 13 - social media. As some Femtech CEOs have learned, social media is heavily gender biased. There is opposition to publishing ads for products directed at women such as lubricants for vaginal dryness in menopause, whereas pills for treating erectile dysfunction are easily promoted33. According to a CNBC report on the matter, male-focused brands like Roman and Hims are able to run ads mentioning “premature ejaculation” or “E.D.” (erectile dysfunction), but Dame, Pulse and other female- oriented brands have to be very Figure 3: A peculiar example of “pink tax” from the COVID-19 era– while the pink masks on the right are not specifically cautious about the terminology they for women, they are priced at 33% above the mundane blue masks. At the time the picture was taken all colorful masks use. Mention of a reproductive organ were priced above the blue ones, but the image was used to portray “pink tax” in Israeli social media at the time. Photo credit – Yael Levanon is grounds for an automatic rejection, but many other terms are also often saying the product simply didn’t fit in censored34 35. but bias in Artificial Intelligence ‒ a the robotics and drones category. The powerful component of our future CNBC reports that companies’ company successfully lobbied to have its – is an even more serious concern. policy is to ban adult products or award reinstated, and featured two new Unfortunately, AI demonstrates bias services “except for ads for family products in the subsequent exhibition as its human creators do38, whether 36 planning and contraception .” It in 2020. gender bias towards women39, or racial seems that while men’s dysfunction The double standard is a real bias toward patients in the healthcare was included in “family planning”, 40 obstacle for Femtech business and its system . women’s vaginal dryness was not. ability to promote its products. This Double standard for women’s and There are several major reasons also requires putting more effort and men’s sexual health in the media is a for this phenomenon. The first is money into advertising. Moreover, it well-known historical phenomenon, the database the algorithm trains blocks women - potential users - from but it is sad to find that it trickled down on. The database can be biased if better understanding of their health or to new media as well. CNBC pointedly the data included are partial, do not wellness needs, as well as from getting states that men’s sexual products refer to certain groups of population to know possible solutions. raised almost 100 million Dollars each (perhaps because of their limited in funding, more than ten times as Underrepresentation of women’s access to the healthcare system) or much as the new Femtech companies. health issues in the media implies that reflect medical practices that were it is a matter of secrecy and shame. not designed for them. Unfortunately, In a famous sextech-related Even now, removing the taboo and as detailed before, medical research incident in CES 2019 in Las Vegas, an representing women’s health needs, and data have suffered from a long history Innovation Award was revoked from specifically menopause in social media, of gender bias and therefore should Lora DiCarlo’s Osé Robotic Massager, is more complicated than one would be scrutinized carefully before use. the CTA stating that the rules specify think. When algorithms train on a flawed that products that are “immoral, database which contains gender or 37 obscene, indecent, profane or not Gender Bias in Artificial Intelligence racial partiality, it can reproduce this in keeping with CTA’s image will be 41 Bias in social media, an important bias into the AI’s predictions . disqualified”, later backtracking and factor for business today, is disturbing,

33 https://www.cnbc.com/2019/03/09/facebook-blocks-ads-for-menopause-products-but-allows-ed-ads.html. See also, https://www.geekwire.com/2019/seattle-startup-battles- facebook-ads-promoting-womens-health-products-ceo-claims-gender-bias/ 34 https://www.cnbc.com/2019/03/09/facebook-blocks-ads-for-menopause-products-but-allows-ed-ads.html. According to the report there are cases in which companies man- aged to publish adds on menopause and the grounds for the difference are not clear. 35 https://www.businessinsider.com/sex-tech-startups-criticize-mta-policy-banning-sex-toys-2019-8 36 https://www.cnbc.com/2019/03/09/facebook-blocks-ads-for-menopause-products-but-allows-ed-ads.html?__source=sharebar|email&par=sharebar 37 Parts of the analysis of AI in this sub-section are based on Keidar Roy & Tavory Tamar, “Legal and Regulatory Aspects of AI in Medicine“, in Emerging Technologies: The Israeli Perspective (Lior Zemer, Dov Greenbaum and Aviv Gaon, eds, Nevo 2021) (Heb) to be published. 38 Cathy O’Neil. 2016. Weapons of Math Destruction: How Big Data Increases Inequality and Threatens Democracy. Crown Publishing Group, USA. 39 Taylor Telford, "Apple Card algorithm sparks gender bias allegations against Goldman Sachs", Washington Post, https://www.washingtonpost.com/business/2019/11/11/ap- ple-card-algorithm-sparks-gender-bias-allegations-against-goldman-sachs/ 40 Heidi Ledford, Millions affected by racial bias in healthcare algorithm, Nature, News in Focus, 31.10.2019 vol 574. 41 Michael Matheny, Sonoo Thadaney Israni, , Mahnoor Ahmed, Danielle Whicher, Artificial Intelligence in Health Care: The Hope, The Hype, The Promise, The Peril Nation- al Academy of Medicine, Washington, 2019. - 14 - A second reason is the lack of diversity by engineers and Of course, AI can be used to make medical treatment more developers of AI systems. According to AI NOW’s 2019 report, equitable. One example is MIT’s image-based deep learning only a small percentage of developers are women42. The model that can predict breast cancer44. Many early models fear is that developers’ perceptions would affect their work were developed based on white populations and were much products. less accurate for other races. The MIT model, however, claims that it is equally accurate for white and black women A third reason is the absence of a mechanism to examine and explains this is especially important given black women’s gender bias or other forms of bias before the product goes higher death rate from breast cancer due to various reasons, to market. It can be very difficult to detect a bias in the including less access to healthcare. algorithm before it enters the real world. In these cases, discriminating outcomes can be revealed only after the AI While Femtech companies that develop AI are expected encounters patients. to be naturally aware of gender bias, they should also be sensitive to bias on different grounds, such as race, age, socio- Possible solutions discussed recently include transparency economic situation, etc. This requires carefully scrutinizing of the databases and their components, explainability, the database to make sure it includes diverse groups of (i.e., use of methods and techniques to explain the way women, considering special medical needs when relevant, algorithms work in a detailed mathematical way so experts documenting the algorithmic work so it can be traced back, and developers can review and analyze them), examination examining the outcomes and predictions and monitoring the of AI products for disparity before and after they are in the AI product during its life cycle45. market, educational guidance for developers and efforts on diversity in the industry, and post-marketing monitoring mechanisms43.

42 AI Now, Discriminating Systems, Gender, Race, and Power in AI, April 2019. According to this report, "Recent studies found only 18% of authors at leading AI confer- ences are women, and more than 80%of AI professors are men. This disparity is extreme in the AI industry. women comprise only 15% of AI research staff at Facebook and 10% at Google. There is no public data on trans workers or other gender minorities. For black workers, the picture is even worse. For example, only 2.5% of Google’s workforce is black, while Facebook and Microsoft are each at 4%.” 43 Samek, Wojciech. Explainable AI: Interpreting, Explaining and Visualizing Deep Learning. Vol. 11700. Springer Nature, 2019. 44 http://news.mit.edu/2019/using-ai-predict-breast-cancer-and-personalize-care-0507 45 For further reading on AI in medicine and the need for its regulation see: Michael Matheny, Sonoo Thadaney Israni, Danielle Whicher, Mahnoor Ahmed, at footnote 41, and Keidar & Tavory,at footnote 37.

- 15 - PART 3 Promoting Women’s Health with Digital Health Tools CHALLENGES AND CONCERNS

The promotion of women’s health through new medical technology is long overdue, and the first steps are already being made. These are hindered by various factors such as biases by investors, social media and other vendors, cultural taboos, and anachronistic attitudes of some healthcare systems. Familiarity with these obstacles can help the entrepreneur wishing to innovate in women’s health to overcome them. To this end, it is important to delve into regulations and cultural norms affecting Femtech in the target market.

The tools, methods and norms of Digital Medicine warrant special consideration when dealing with women’s health and health data, because of the great potential for harm, and so we have proposed a list of principles that would ensure fairness and value for women employing digital health tools, even when not mandated by regulation.

- 16 - Women’s Health Data in the However, the advent of digital "Intimate surveillance Information Age health and its use of data brings new – monitoring, recording challenges and concerns. Below, we After overcoming the unseen question the reasons for collecting this and quantifying these very barriers, mostly unique for the sensitive data. Then, we discuss the personal activities ‒ has Femtech industry, a Femtech company challenges arising from data collection become the norm. Are we is required to address a more general and data flow to the health care digital-health concern – the data which provider–patient relationship. At the losing intimacy to gain generate its products. end of this chapter, we will describe the more knowledge, and is it The information revolution has of regulatory safeguards for the protection really a necessary trade- course not passed over healthcare. This of such data, and its drawbacks. At the includes unlimited access to health end of the article we will suggest a new off?" information online, the proliferation paradigm for better handling of data in of wearable or home-use sensors, the the Femtech industry. monitoring, recording and quantifying use of machine learning and artificial Why Are We Collecting these Data? these very personal activities ‒ has intelligence to predict illness or Intimate Surveillance become the norm. Levy explains that support medical decisions, and the this intimate(PHOTO) surveillance gives us the Privacy is a chief concern when transformation of smartphones into perception of control and objectivity collecting and using data. Personal at-home medical labs, exam rooms and even when they do not exist47. She information is aggregated, analyzed, doctors’ offices. Femtech apps hold a also warns of inherent risks, when crossed with other databases, and more promise of accreting large amounts of technologies become a tool for abuse data from patients and using them for importantly, kept on the internet for an indefinite period of time. Femtech and revenge or “just” for targeting the patient to keep track; for the doctor users for cyber-attacks. to use as an extended patient history, or companies collect very sensitive data: for AI engines to provide new insights. menstrual tracking, fertility treatments, This raises several questions: pregnancy follow-up, sexual activity is “intimate surveillance” really Data also enhance patients’ and so on. Some Femtech products necessary to address women’s healths empowerment and their confidence and services require collecting and needs? Are women more vulnerable to voice their special health needs and saving information over a long period when intimate surveillance is the pains. Today’s healthcare consumers no of time to get the best results (e.g., norm? who gains the most from it? Did longer accept the patronizing medicine fertility treatments and menstrual we embrace “men’s” technology into of the past, with its “doctor knows cycle tracking). women’s sphere too quickly? best” attitude. Increasingly, due to the information revolution, patients are If leaked, feminine health Is there a real need to document better informed, knowledgeable about information might affect the public a girl’s menstruation cycle from a image of a person, her social status their rights, and expect a conscientious, young age until she decides to bear and her relationships. It can also have humane approach from their doctors. children? Are we too quick to jump an adverse effect on her chances of from technology (self-monitoring) For example, Femtech products employment, credit card rating and empower patients going through insurance. So before anything else, one to a solution (menstruation cycle fertility treatments with fertility should ask why we collect this sensitive recording), when no specific need tracking apps, devices for monitoring information. is present? Is it not another way for cervical mucous, apps accompanying the scientific or pseudo-scientific- women during fertility treatments, and In her article “Intimate Surveillance”, technological regime to “medicalize” more. These digital applications are Karen Levy examines the rise of the women’s health and bodies?48 Do geared toward maximizing women’s surveillance paradigm within the most ongoing health diaries contribute to autonomy and control over their intimate behaviours along a woman’s patients’ health, whether scrutinized life cycle ‒ love, romance, sexual by a physician in real time or fertility and reducing their dependence 46 on doctors. activity, fertility and pregnancy . She afterwards, or by the patient herself? points out that intimate surveillance –

46 Karen E.C. Levy, “Intimate Surveillance”, Idaho Law Review 51 679 (2015). Levy describes how the intimate surveillance starts from dating apps, in which potential partners are being rated, and apps in which intimate and romantic practices are recorded and quantified, to be rated, and women’s health apps in which sexual activity, menstrual cycle, basal body temperature and birth control measures are being documented. 47 Although the supposed control relates only to what is measured and documented, and this is of course not a neutral method. Levy, at footnote 46, 688. 48 For a personal perspective on why a period app did not suit her as a woman, see Kaitlyn Tiffany, Period-tracking apps are not for women"https://www.vox.com/the- goods/2018/11/13/18079458/menstrual-tracking-surveillance-glow-clue-apple-health

- 17 - on her own, her ability to own her Apps that automatically forward information – to understand it and data to a caregiver or telemedicine use it at her will – grows stronger. This “clearinghouse” create an expectation "When developing strengthens the democratization of the for caregiver intervention in case of the medical treatment. This “ownership” of appearance of agreed-on symptoms, Femtech products information can assist the patient when and require the provider to put in place and specifically her conditions are met with disbelief or the required infrastructure for handling medical apps, one ignorance by the medical profession, this sort of traffic, usually by human such as is the case with pain syndromes caregivers. should construe them (especially endometriosis) but also Another challenge arises from the having both patient PCOS, menopause, and others, and of digital diaries or symptom trackers course with the ostensibly mundane but and doctor in mind" describing the patients’ condition over complex and emotionally fraught area a period of time. These do not ensure of fertility. The documented symptoms the physician’s belief, who may not can serve as a testimony to convince feel there is a difference between oral the physician. Even if they do not, they What can a physician do with history and digital tracking. information that has no known medical might serve as a source of strength and meaning? What can the patient do confidence for a patient to ask questions Additionally, being confronted with with it – does it really empower the and present her medical condition large volumes of patient-generated data patient or just give her a false feeling better. from trackers is a new experience for most physicians, who may find it hard of control? Are we losing intimacy to However, it is important not only to to discover pertinent clinical insights gain more knowledge, and is it really a consider the advantages to caregivers hidden inside. Digital apps should necessary trade-off? and patients, but to also be mindful of make an effort to collate important data their risks or limitations. Here are the and insights for the physician, while These questions do not rule out main concerns about how the collection ensuring access to the raw volume as the importance of using tracking and use of health data will affect the well. technology when needed and when physician-patient relationship50. it promotes women’s healthcare. We The fact that patient-physician First, a patient tasked with collecting argue that the need for this technology relationship is affected by the her own data (be it signs, symptoms, should be considered and weighed intermediation of a digital app is or otherwise), might mistakenly be against the privacy concerns and risks. another main concern. While such an thought of as transferring some of the addition is potentially an empowering Data Collection's Effect on responsibility for diagnosis from the one for both the patient and the doctor, Healthcare Provider–Patient physician to herself. The physician it can also provide an impediment Relationship is expected to adequately explain the if not handled correctly. The shared symptom-tracking process to the patient The effect of using medical apps experience of using medical apps and ensure her understanding; but also, and accumulating large amounts should be engineered with both parties to employ the additional professional of personal health data on the in mind, ensuring it is beneficial and means at her disposal to reach the physician-patient relationship and smooth rather than detrimental. diagnosis beyond the patient’s digital on the provision of healthcare is still symptom tracker. unknown. The advent of electronic health records in the past two decades has brought to the fore the question of who owns the patient’s information – whether the patient, the caregiver, the insurer, the Electronic health records platform or others – as well as questions such as who may use it and how it may be used, and what type of consent is required49. As the patient produces, handles and manages more medical information

49 These questions can be answered from a legal perspective, but this is a topic this article will not dwell on. 50 These limitations might carry legal ramifications, and specifically liability risks, that will not be discussed in this article.

- 18 - PART 3 “Covered Entities” and “Business Promoting Women’s Associates” Covered by HIPAA If Femtech products or services health with digital are defined as “covered entities” or “business associates” acting on their health tools behalf54, they are regulated by HIPAA It is clear that health data collection – the Health Insurance Portability and and medical apps will have heavy Accountability Act. Main examples implications on the physician-patient of “covered entities” are healthcare relationship. When developing providers that transmit electronic Femtech products and specifically personal healthcare information, medical apps, one should construe clinics, hospitals, pharmacies, HMOs, them having both patient and doctor health insurance companies and in mind. Some of the implications healthcare clearinghouses. Business described here should be addressed associates are businesses acting on legally, ethically and technologically behalf of covered entities, for example to protect the safety and quality of a cyber-security company that protects medical treatment as well as the the hospital’s medical equipment and physician-patient relationship in the has a contract with the covered entity. new era. HIPAA’s Privacy Rule permits use Health Insurance Portability Protection of Data - the Legal and disclosure of protected health and Accountability Act Framework information, without an individual’s authorization or permission, for After deciding which data one 12 national priority purposes, such needs to collect, and after designing as when it is required by law or for the product with doctor-patient research under certain conditions. An important challenge is that of relationship in mind, protecting the ensuring access – digital healthcare data is of crucial importance. In the In addition, HIPAA regulates tools are not equally accessible to USA, the Health Insurance Portability only individually identifiable health all populations. Some help-seeking and Accountability Act (HIPAA) is information. It permits the use and populations may be more prone than the main regulatory mechanism disclosure of information that neither others to not be able to fully utilize for protecting health data51 and the identifies nor provides a reasonable digital apps due to socio-economic Federal Trade Commission Act (FTC) basis to identify an individual. The factors such as age, computer illiteracy completes it52. Their requirements de-identification rules and methods or underprivileged economic status. will be described hereinafter53. At are detailed in the law and in HHS Old modalities for diagnosis and care the end of this chapter, we explain guidance55. should be maintained for the sake of why the regulatory safeguards are these populations, while efforts are According to HIPAA’s security not enough and why the protection rule, covered entities and business made to improve their access to such of sensitive data accumulated by care. associates are required to ensure Femtech products and services the confidentiality, integrity, warrants change.

51 https://www.cdc.gov/phlp/publications/topic/hipaa.html 52 For an analysis of the two regulatory regimes see, Reece Hirsch and Jenny Harrison, Digital Health Privacy: Old Laws Meet New Technologies, The Journal of the Antitrust, UCL and Privacy Section of the California Lawyers Association.1, Vol 27, No. 1 Winter 2017-18. Other federal laws that govern the collection of information online include the Children’s Online Privacy Protection Act 1998, governing the collection of information about minors, which will not be dealt with in this article. 53 The states’ legislation will not be reviewed in this article. However, note that the CCPA (California Consumer Protection Act) excludes health information governed by federal and state data privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA), and California's Confidentiality of Medical Information Act (CMIA). The different laws (HIPAA, CPA and CMIA) define the main terms differently, so a careful examination is required to make sure if CCPA applies to a certain business or to a certain personal health information or not. 54 5 C.F.R. Part 160, Part 162, and Part 164. 55 The Privacy Rule provides two de-identification methods: 1) a formal determination by a qualified expert; or 2) the removal of specified individual identifiers as well as absence of actual knowledge by the covered entity that the remaining information could be used alone or in combination with other information to identify the individual. In an attempt to minimize the risk that de-identified data would be re-identified, the de-identification process is required be held according to HHS detailed guidance. Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule November 26, 2012. https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/coveredentities/De-identification/hhs_deid_guidance.pdf

- 19 - PART 3 “Companies must not mislead consumers about what is happening with their health information.”

and availability of all electronic requirements designed to prevent HIPAA’s breach notification rule63. protected health information, such acts or practices59. The FTC breach notification rule detect and safeguard against was criticized as covering a narrow This Act prohibits companies from anticipated threats to the security spectrum of vendors and cases64. engaging in deceptive or unfair acts of the information, protect against Recently the FTC asked for comments or practices in or affecting commerce. anticipated impermissible uses or on the rule after ten years since its HHS explains that “Among other disclosures and certify compliance enactment65. things, this means that companies by their workforce56. They must must not mislead consumers about GDPR in Short administer policies and procedures to what is happening with their health implement administrative, physical, To complete the picture, some information.”60 A company may be technical and other safeguards. The wording on the General Data held responsible by FTC if it makes an law does not dictate those measures Protection Rule (GDPR) is required. inaccurate or misleading statement in but requires that the relevant The GDPR governs the collection, use, its privacy policy or has insufficient considerations be taken into account. transmission, and security of personal security that is unfair or causes In addition, covered entities and data collected from data subjects in the damages to consumers (thus, possibly their business associates are required European Union. The GDPR applies to creating potentially deceptive or to provide notification following such data regardless of the location of unfair practices)61. However, the FTC a breach of unsecured protected the entity collecting and/or processing Act does not detail the privacy and health information, if they retained the data. The GDPR defines, among security requirements as HIPAA does. information in a way that is not in other types of data, “data concerning accordance with the HHA security In addition, the FTC’s breach health or data concerning a natural guidance57. HIPAA violations may notification rule requires vendors of person’s sex life or sexual orientation” result in civil monetary or criminal personal health records62 to report as a special category of personal data penalties. breaches of unsecured protected and accords it a higher standard of health information, similarly to protection66. Other Companies Covered by the FTC Act

Femtech companies that do not 56 https://www.cdc.gov/phlp/publications/topic/hipaa.html qualify as “covered entities” or are not 57 45 CFR §§ 164.400--418, https://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html “business associates” (for example, a 58 The Mobile Health Apps Interactive Tool helps developers understand if they are considered business associates menstrual tracking app that does not or not. Federal Trade Commission in cooperation with the U.S. Department of Health & Human Services (HHS): the Office of the National Coordinator for Health Information Technology (ONC), the Office for Civil Rights (OCR), involve a physician or is not covered and the Food and Drug Administration (FDA) , “Mobile Health Apps Interactive Tool,” April 2016, available at by a health insurance plan) might still https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool be required to adhere to the Federal 59 https://www.ftc.gov/enforcement/statutes Trade Commission Act58. 60 https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-ftc-act/index.html 61 Reece Hirsch and Jenny Harrison at footnote 52. According to the Federal Trade 62 According to the FTC Act, these vendors include vendors of personal health records – which provide online Commission Act the Commission is repositories that people can use to keep track of their health information – and entities that offer third-party empowered, among other things, to applications for personal health records. 63 https://www.ftc.gov/news-events/press-releases/2009/08/ftc-issues-final-breach-notification-rule-electronic- prevent unfair methods of competition health and unfair or deceptive acts or 64 https://www.hipaajournal.com/ftc-seeks-comment-on-health-breach-notification-rule/ practices in or affecting commerce, 65 https://www.hipaajournal.com/ftc-seeks-comment-on-health-breach-notification-rule/ to prescribe rules defining with 66 Special categories of data are defined as personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data specificity acts or practices that are for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural unfair or deceptive and to establish person’s sex life or sexual orientation.

- 20 - According to the GDPR, a In some cases, providing consent “controller” (a party that determines is the only way a person can access the purposes and means of processing) important services, whereas not is required to have a legal basis for agreeing to the company’s privacy processing data. The GDPR details policy necessarily means not receiving six legal bases for processing data, these services. In addition, the consent such as performance of a contract, forms tend to be long and burdensome data subject’s consent and legitimate in such a way that many people tend interest of the controller. In addition, to skip them or sign electronically considering that health data is without fully understanding what they sensitive, the GDPR requires extra are signing67. This phenomenon was legitimization, which includes, for named “the click fatigue” to portray It is not clear whether example, explicit consent of the data the automation of consent. regulatory security subject. In the past, a patient shared with measures are supplying A "processor" is the party her physician the most intimate adequate protection in processing the data on behalf of details of her life in the medical the controller, and is obligated to encounter. Based on a relationship of light of cyber-attacks on ensure that data is processed solely as trust, the physician could ask for the health related matters directed by the controller. The GDPR transfer of medical information to a and the sensitivity of requires the controller and processor third party (for example for research). femtech data. to have technical and organizational Today, consent and electronic consent measures in place, ensuring the data for transfer of medical information is kept secure, while considering the occurs completely outside of this sensitive nature of the information. physician-patient relationship, and trust is hardly spoken of. The Limited Power Of Consent Or Why Regulatory Safeguards Are Considering the limitations of Simply Not Enough consent and the sensitivity of personal health information, this article argues From the regulatory review above, for a new paradigm to be constructed it seems digital health products are for Femtech products and services legally protected, at least when used by ‒ an ethical code based on values of HIPAA-covered entities and business confidentiality and trust. associates. However, many medical apps are not covered by HIPAA, and thus are entitled to a lower level of regulatory protection. In addition, practically speaking, it is not clear yet if these regulatory security measures are supplying adequate protection in light of cyber- attacks on health-related matters and the sensitivity of Femtech data. Moreover, the mechanism of consent, although viewed as the ultimate expression of control and autonomy, can hardly be regarded as such. In the era of information, this is a serious loophole when discussing digital health tools, consequently allowing the transfer of personal health information for non-medical reasons.

67 For examples of the time required for reading privacy policies and terms of use of popular apps, and the level of education required for understanding them, see https://www.visualcapitalist.com/terms-of-service-visualizing-the-length-of-internet-agreements/

- 21 - PART 4 The Social Stance of Femtech Companies and a BUSINESS ETHICAL CODE

The promotion of women’s health through new medical technology is long overdue, and the first steps are already being taken. These are hindered by various factors such as biases by investors, social media and other vendors, cultural taboos, and anachronistic attitudes of some healthcare systems. Familiarity with these obstacles can help the entrepreneur wishing to innovate in women’s health to overcome them. To this end, it is important to delve into regulations and cultural norms affecting Femtech in the target market.

- 22 - PART 4 The Social Stance of Femtech Companies and a Business Ethical Code

A profit-targeted company is not Consequently, this article suggests you are working under a legal duty of a natural partner that can substitute applying components of the physician- medical confidentiality. If not, state so a relationship or an ethical code. patient relationship, and specifically clearly and explain which standards However, in the digital health world, ‒ confidentiality and trust, to the you applied. where digital health tools become an Femtech world. Accordingly, this D. Anonymize when possible – integral part of the healthcare system, article suggests creating a voluntary make sure you do not store identified in some cases as part of the physician- business code, on top of the current or identifiable health information at patient relationship, and in other cases legislation. all, or at least not outside of the user’s as part of a patient’s self-monitoring, a This code would be aimed at personal device. As a general rule, new paradigm is desperately needed. establishing confidentiality, trust and identified or identifiable information In conducting research for this commitment, as well as higher ethical should exist only in the user’s device article, we encountered an ethical standards concerning the promotion storage. attitude not pervasive throughout the of women’s health. It is not phrased in E. Ask for consent – if there is no Healthtech ecosystem. Most if not all legal terms and should not be viewed other choice but to store identified or of the firms, organizations, or founders as a suggestion for a legally binding identifiable health information, make researched or interviewed, though document (although some parts are sure to receive the user’s clear consent placing business success as their top already legally required in certain for storing identified or identifiable priority, were also deeply committed cases, by certain regulations). The health information on the user’s to positive social change. As a general suggested code would be based on the device or outside of it, and minimize rule, many Femtech companies are following principles. the information. User consent is not a committed to the improvement not A. Data minimization – ask only silver bullet. only of women’s health, but also their for what you have to know for the rights in general, in what we have purpose of selling your product or F. Do not transfer identified come to call “[Glass] Ceiling Breaking” rendering services. or identifiable information to a behavior. Such ceiling-breaker third party. Analytics and statistics companies may devote a percentage B. Data collection policy – (which are non-identifying) can be of proceeds to empower girls and constitute a data collection policy that transferred to a third party or used on young women in developing countries has clear purposes as well as medical a third-party platform, as long as you by ensuring their menstrual equity; rationale and standards. If the data notify the user clearly ahead of time. target underserved populations for do not serve the medical rationales, It is understood that this rule will not telemedical consultations, improve they should not be collected (i.e., data enable certain business models and access to obstetric or oncologic care for minimization). serves only as an ethical guide to what women in the social or geographical C. Confidentiality commitment should be aspired to. periphery, and more. We suspect that – clarify if you are a “covered entity” G. Encrypt ‒ make sure to use in most if not all cases, this approach or “business associate” under HIPAA proper encryption on identified or stems not from a cynical decision but or if according to the state’s legislation identifiable information, when it is from a genuine desire to do good.

- 23 - stored or in transit (think: cellphone validation or the lack of it in a plain or laptop theft or cyber-attack on your and clear manner68. This article suggests servers). Protection by encryption is applying components J. Transparency and not a privilege, but a necessity. Explainability when Artificial of the physician- H. Education, disparities, and Intelligence is involved – patient relationship, access to healthcare system – educate incorporating AI in medical and specifically ‒ and consider how you can bridge treatment or in medical apps requires confidentiality and over disparities. As described in the transparency and an appropriate previous chapter, there are many monitoring policy. In this article trust, to the Femtech obstacles to addressing women’s we analyzed this important topic world. Accordingly, health needs, including cultural in detail, but it is recommended to it suggests creating a barriers, social bias, limited access monitor the AI’s database and its voluntary business to healthcare services, special needs outcomes for bias or mistakes, before (for example, for minorities and and after marketing. In addition, code, on top of the women with disabilities) and so on. It transparency and explainability, current legislation." is imperative to think of the different including algorithmic transparency, groups of women while developing are key components in the process, Femtech solutions. This kind of enabling professional scrutiny thinking can result in re-defining whenever needed69. the potential markets, re-shaping the K. Patient empowerment product to fit special needs, or adding 71 - suggest how the product will technologies . These concerns, together educational guides to explain the needs promote patient empowerment and perhaps with the legislation of CCPA, or the solution in a way that would draw expectations from the medical have already led certain large companies fit the audience. Address healthcare 72 profession, if relevant. to tighten their privacy policies . disparities and digital illiteracy when Another example is a tutorial created possible and document your decision The code obviously does not suit by Apple for prospective developers process on the matter. every company and every business to explain the changes incorporated model, and it is possible that it into their privacy protections and the I. Fairness and Medical 73 requires further discussion. However, way they work . Business codes can Validity – Be Fair! Fairness cannot this suggested code can serve as a help companies mark themselves as be overrated. In this article we do preliminary basis for developing committed to a higher ethical standard, not discuss the important topic of each company’s ethical framework. while promoting women’s health. scientific validation. As is the case It is also suggested to review this with many digital health apps, many The acceleration of digital health code from time to time according to Femtech apps are not regulated as provides the Femtech industry with technological developments. opportunities of promoting new levels of a medical device, and hence, are care in womens' health, and answering not required to meet any scientific Having a business code can help medical needs that have been previously threshold. Such apps will have to Femtech companies answer public ignored or neglected. In this article we follow the FTC Act’s fair and non- concerns as to the protection of their pointed out the historical, medical, deceptive practices rule, but it seems intimate data and prepare themselves legal and social obstacles confronting there is a large grey and unregulated for users’ demands in this field. the Femtech industry, and ways of area of scientific validation. We Research shows that customers overcoming them. Furthermore, the suggest a twofold ethical obligation of Femtech industry can lead the digital are changing suppliers and services fairness: first, explaining medical data health care industry into applying higher according to their ethical standards70. to users in an appropriate manner standards of conduct, strengthening A main example is IBM’s decision so that the data can be understood. confidentiality and trust as the base for to stop using facial recognition Second, explaining the scientific digital health care.

69 For a recommended policy for incorporating and monitoring AI in medical treatment, see Keidar & Tavory, at footnote 37. 70 https://www.aflac.com/about-aflac/corporate-citizenship/default.aspx?utm_medium=multiple&utm_source=vanity&utm_campaign=corpcomm_2015&utm_term=acsr 71 IBM will no longer offer, develop, or research facial recognition technology, the Verge,https://www.theverge.com/2020/6/8/21284683/ibm-no-longer-general-purpose-facial-recogni - tion-analysis-software 72 https://www-marketwatch-com.cdn.ampproject.org/c/s/www.marketwatch.com/amp/story/what-google-and-amazon-are-doing-to-comply-with-californias-new-privacy-law-2020-08-18 73 https://developer.apple.com/videos/play/wwdc2020/10676/ - 24 - Acknowledgments: The authors wish to acknowledge the kind assistance of Adv. Netanella Treistman, partner at Yigal Arnon & Co. for her comments on privacy matters. Additional thanks go to the entrepreneurs and scientists who assisted us in our research (in alphabetical order): Brittany Baretto, Rachel Braun Scherl, Amy Buckalter, Megan Capriccio, Patricia Cervantes Santana, Keren Leshem, Sara Marska-Maj, Anthony Morrison, Soumyadip Rakshit and Sharon Rashi Elkeles. The authors remain responsible for the contents of this article. Special thanks to Cynthia Leffler for the professional design.

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