11 October 2020

Post No. 4 – A Stethoscope of One’s Own - Femtech (Feminine Technology)

By Adv. Tamar Tavory & Itamar Netzer, MD, OB/GYN

Did you know that the gynecological speculum was invented in 1845, under dubious circumstances?[1] If you don’t know what a speculum is, you’re probably, well, a man. A speculum is the ubiquitous, uncomfortable, and often painful implement used for routine gynecological pelvic exams. But in the age of robots, AI, and space medicine, has no one thought to reinvent the speculum?

For years, medical science has been based on the male physique, and medications were developed without considering the unique characteristics of women. The most noteworthy example is myocardial infractions, that are often expressed differently in women than in men, leading to a delayed diagnosis in many women having a heart attack, but many differences exist in pulmonology, metabolic disorders, autoimmune diseases and more. In the area of clinical pharmaceutical research, many drugs were tested only on men, whether out of convenience or because of the fear of administering a new drug to an unknowingly pregnant woman, and possibly compromising the fetus. In certain cases, we are only beginning to understand the full effect of drugs on women. Moreover, women’s health issues, such as menstruation or childbirth, were often held as taboo, shameful or requiring concealment, and thus were not addressed adequately.

Femtech companies address women’s distinct health and medical needs through various technological means: telemedicine, medical apps, medical devices and more. The value of Femtech is estimated to reach $50 billion by 2025.[2] Studies demonstrate that in many households, women make most of the medical decisions and decisions about shopping.  Women thus exert significant purchasing power.

Femtech companies work in areas such as menstruation, pregnancy, termination of pregnancy, stillbirths, menopause and sexual wellness. For example, there are Femtech companies that home deliver oral contraceptive pills and breastmilk, and digitize fertility treatments or reduce obstetric trauma. Some Femtech companies are active against diseases that affect mostly women such as autoimmune diseases, depression, osteoporosis or breast cancer.

What to Consider if You Decide to Develop a Femtech Product?

Femtech companies naturally collect sensitive data: menstrual tracking, fertility treatments, pregnancy follow-up, and sexual activity. This sensitive information legally requires an adequate level of information security, to ensure that the data are not stolen or passed on to unauthorized persons. The leak or theft of sensitive information would not only have an extremely detrimental effect on the product, but also possibly lead to significant suits due to breach of privacy.[3]

It is recommended that relevant products be designed to collect as little sensitive information as possible, and to keep sensitive information anonymized or under encryption in a way that doesn't permit attributing data to a specific patient.

Regulations for privacy protection are determined in accordance with the national legislation of the home state, where the company operates, and the country of the patient whose data is involved. As a rule, privacy policy should be determined to clarify the purpose of data collection regarding the patient, the method or system of data storage, the method and procedure of data transfer to a third party in Israel or abroad, including via cloud.

If information is used for purposes beyond the service provided, this should be expounded to the user, and her prior consent must be given. Data storage and security must comply with local regulations pertaining to information storage.

In addition, Femtech products raise questions related to the liability aspects of product misuse or medical treatment following use of the product, and the division of responsibility between the manufacturer and the medical institution (pregnancy and fetal care especially raise this concern); the more involvement required on the part of the user in her care, such as performing remote ultrasound or fetal monitoring on herself, the more concerns are raised regarding the provider’s responsibility in this context (i.e. should the provider have seen the reported findings immediately, should they have referred to the patient to face-to-face care, etc.)

Additional concerns are related to misleading advertising, deceptive practices or non-compliance with consumer protection laws, such as unlawfully attributing a medical effect to a product (e.g. claiming it prevents pregnancy when this is untrue) or advertising to minors in defiance of existing regulations.

Other legal aspects relevant to the Femtech industry were reviewed here in previous posts, with regard to telemedicine and health apps, and it is recommended to peruse those posts.

For questions or counseling: tamart@arnon.co.il

 

This post is intended to present general information only. It should not be construed as legal advice or legal opinion and should not be relied upon.

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