Pink October: how FemTechs can contribute to women’s health

​During the current pandemic, a new trend has emerged in the healthtechs ecosystem for developing solutions focused on women’s health, including cisgender, transgender and non-binary women. Known as FemTechs, these companies have been gaining momentum for three main reasons:

• Statistically speaking, women are more adept than men at taking care of their own health, routinely attending medical appointments and check-ups to track potential diseases;
• Women’s health requires more care than men’s health, considering factors such as pregnancy, breastfeeding and menopause;
• With quarantine rules, social isolation and restrictions on movement, the pandemic has made it even more urgent to develop services and products that could help women monitor their health, whether clinically or remotely – for example, in relation to pregnancy and postnatal care, fertility monitoring for women who have postponed pregnancy plans, as well as in treating chronic diseases.

According to data from the Inside Healthtech Report (published by innovation and technology organization Distrito), Brazil has more than twenty established FemTechs. The American consultancy firm Frost & Sullivan estimates that FemTechs should be worth USD 50 billion worldwide by 2025, representing an opportunity for the Life Sciences and Healthcare industries to develop initiatives such as:

• Wearable devices and applications for monitoring patients undergoing treatment or for monitoring menstruation and ovulation;
• Virtual telehealth platforms aimed at women;
• Use of blockchain and predictive analysis tools for genetic counseling, family planning support, hormone replacement and clinical decision-making in prevention, diagnosis, treatment and contraception actions;
• Use of artificial intelligence to accelerate the research and development of new treatments for diseases such as breast, ovarian, cervical and thyroid cancer, as well as sexually transmitted and dermatological diseases;
• Point-of-care testing and body temperature measurement devices to assist in diagnosing cancer at an early stage.

These initiatives may be subject to a series of regulations concerning product marketing or health services that use technologies at the regulatory level. The main aspects are addressed below:

Telehealth

The COVID-19 public health emergency resulted in a new law and an ordinance from the Brazilian Ministry of Health being published in 2020. Both the law and the regulation authorized medical practice via technology to assist patients, research, prevent disease, injuries, and promote health among physicians and patients, though they limit this to the pandemic period.

Such long-distance interactions may include pre-clinical care, assistance support, appointment, monitoring and diagnosis, whether within the scope of Brazil’s Unified Health System (SUS), supplementary health or private health.

Furthermore, federal nursing, dentistry, physical therapy and nutrition boards have also established regulations that allow healthcare professionals to use virtual tools during the pandemic.

There is currently an expectation that the National Congress and professional boards will regulate the topic definitively, as the Federal Board of Psychology (CFP) previously did in 2012.

Software as a Medical Device

In a 2001 Resolution establishing technical regulations for medical devices, the Brazilian Health Regulatory Agency (ANVISA) defined Software as a Medical Device (SaMD) as any medical, dental or laboratory use or application intended for prevention, diagnosis, treatment, rehabilitation and contraception.

Aware that patients and healthcare professionals were increasingly adopting software and applications for such purposes, ANVISA prepared a Regulatory Impact Analysis (AIR) on the subject. Moreover, it is currently discussing the creation of specific regulations for SaMD, having even carried out a public consultation in May 2021.

Thus, ANVISA is seeking to bring Brazilian health regulations closer in line with those of foreign health agencies, as well as with the standards established by the International Medical Device Regulators Forum (IMDRF).

Assisted human reproduction

Provided that there is a possibility of success and a low chance of serious health impacts on patients and their offspring, assisted reproduction techniques are allowed when donating eggs or preserving gametes, embryos and germinal tissues, as provided for in a 2021 Federal Board of Medicine (CFM) Resolution. As the result of a recent CFM review, this resolution also establishes new age limits for using the technique, embryos implanted in women and embryos generated in laboratories. The resolution also introduced a requirement for judicial authorization prior to disposing of cryopreserved embryos or those abandoned for three years or more.

Depending on the type of solution that a FemTech develops, additional regulations may apply to its business model, for example:

• The Code of Medical Ethics, which provides general rules applicable to practicing medicine and provides for the rules of medical confidentiality and the physician-patient relationship;
• The Biosafety Law (Law No. 11,105/2005 and Decree No. 5,591/2005 ), which establishes safety rules and inspection mechanisms for activities involving Genetically Modified Organisms (GMOs) and their derivatives;
• A technical regulation concerning national registration in the Germinative Cell and Tissue Banks and how information on human embryos produced by in vitro fertilization is sent; and
• A technical regulation concerning how the Germinative Cell and Tissue Banks function.

Clinical trials on women

For a manufacturer to obtain authorization for marketing drugs and medical devices, each country’s health authority requires it to submit a dossier containing technical evidence on the product. This evidence is obtained through clinical trials to determine the product’s efficacy and safety, confirming or disproving hypotheses about its effects, therapeutic indications, or identifying potential adverse reactions.

Clinical trials on human beings are subject to evaluation by Brazil’s National Research Ethics Commission (CONEP), an entity linked to the National Health Council (CNS), as well as by the Research Ethics Committees (CEPs). Research carried out on pregnant women or women of childbearing age requires a risk and benefit assessment that considers possible impacts on fertility, pregnancy, the embryo or fetus, labor, puerperium (postpartum period), lactation and newborn children.

ANVISA can also regulate the topic to a certain extent, especially if the clinical trial supports the registration of a product in Brazil and its subsequent marketing.

Currently, Brazil’s House of Representatives is discussing a bill that would provide a regulatory framework for the issue, with the Federal Senate having already approved the text under discussion. It proposes a series of changes to make processes inherent to clinical studies progress more fluidly, such as the end of double ethical approvals and criteria stipulating mandatory treatment for participants after the clinical study finishes.

Data Protection

According to the Brazilian General Data Protection Law (LGPD), sensitive personal data regards health or sex life data, genetic or biometric data when linked to a natural person (when identifying an individual). Therefore, if a FemTech wishes to process this data, it must do so under specific legal bases:

• With the consent of the holder or their legal guardian;
• In compliance with a legal or regulatory obligation – for example, identifying a disease that requires health authorities to be notified;
• Implementation of public policies by the Public Administration as provided for in laws or regulations – such as those deriving from the constitutional right to health;
• The carrying out of studies by a research body;
• Regular exercise of rights;
• To protect the life or physical safety of the owner or third party;
• Healthcare within the scope of a procedure carried out by health professionals or health entities;
• To prevent fraud and guarantee the security of the holder.

The LGPD expressly prohibits data controllers from communicating or sharing sensitive health-related personal data in order to obtain an economic advantage. However, exceptions apply to health services, pharmaceutical assistance and healthcare when in the interests of data holders, as well as to allow data portability (when requested by the data holder), or otherwise for financial and administrative transactions resulting from the use and provision of health and pharmaceutical care services and healthcare.

For more information, please contact Mattos Filho’s Life Sciences and Healthcare practice.

*With the collaboration of Lucas Barreto.