Watch out for the FemTech legal pitfalls - Naomi Pryde

As a female lawyer working in the life sciences sector and the owner of a “wearable”, I’m fascinated by FemTech (a term describing technology designed specifically to address women’s health needs). It’s an industry predicted to be worth more than $103 billion by 2030, and so I’m definitely not the only one!

FemTech is rapidly gaining momentum in Scotland, the first UK country with a Women’s Health Plan specifically designed to improve access to healthcare and reduce women’s health inequalities. This gender health gap - the less well-known sister of the gender pay gap - has recently received attention thanks to books such as Invisible Woman and Unwell Women.

In recent years, FemTech has gained significant traction, driving innovation, empowerment and improving outcomes for women’s health. From menstrual health to fertility, it has revolutionised the way women approach their health and well-being.

Lately, Scotland has emerged as a hub of FemTech innovation, with several start-ups and organisations leading the charge in developing cutting-edge solutions. These advancements aren’t only empowering women to take control of their own health but also challenging traditional gender biases in healthcare and promoting gender equality.

Naomi Pryde is a partner in DLA Piper’s Litigation and Regulatory practice, based in Scotland

As a 30-something woman seeking to better her health, I’m incredibly excited about FemTech. However, as a lawyer, it’s difficult not to consider the legal landscape surrounding these innovative technologies.

Regulation is one significant legal aspect worth considering. As products and services often involve sensitive information and impact women’s well-being, they are subject to various regulatory requirements. In the UK for instance, menstrual tracking apps, fertility tracking apps and smart medical devices must comply with data protection laws, including the General Data Protection Regulation (GDPR), which governs the collection, use, and protection of personal data.

Companies operating in the FemTech space must ensure they collect and process user data in compliance with applicable data protection laws.

Clearly menstrual and fertility trackers collect sensitive personal health data, such as the timing and duration of menstrual cycles, symptoms, and other related information. The data collected can be valuable information for women trying to conceive or avoid pregnancy. As such, it’s crucial to obtain valid and informed consent before collecting, using, or sharing user data. Failure to do so could result in privacy breaches and litigation risks, including claims related to lack of informed consent or improper handling of user data.

‘Wearable’ technology has the potential to drive innovation, empowerment and improve outcomes for women’s health

There have been concerns raised about how the data contained within FemTech apps may be used after the US Supreme Court overturned Roe v. Wade in June 2022, resulting in many states criminalising abortions.

FemTech products and services may also be subject to regulations from health authorities. For example, medical devices, such as smart Kegel trainers or breast self-examination devices, may need to undergo regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in Scotland to ensure safety and efficacy.

Companies must also navigate the complex regulatory landscape and ensure their products and services comply with relevant laws to avoid litigation risks, such as fines, penalties, or product recalls.

Product liability is another significant legal aspect of FemTech in Scotland. FemTech products and services, particularly medical devices, may pose risks to users if they are defective or fail to perform correctly. In such cases, users may suffer physical harm or adverse side effects, leading to potential product liability claims. Companies must ensure their products and services comply with relevant regulations and standards.

Litigation may also arise through marketing FemTech products and services. Companies must ensure that their advertising and marketing practices comply with relevant laws, including consumer protection laws and advertising standards. For instance, companies must avoid making false or misleading claims about the benefits or effectiveness of their products or services.

Failure to comply with advertising and marketing regulations may result in litigation risks, including claims of false advertising or unfair business practices.

While the cost of some FemTech products mean they aren’t presently available to all, more women will be able to benefit as their accessibility, affordability and visibility increases. As long as companies working in the FemTech space carefully consider compliance, privacy, accuracy and inclusivity, FemTech has the potential to empower women, improve access to reproductive health care and promote positive health outcomes.

Naomi Pryde is a partner in DLA Piper’s Litigation and Regulatory practice, based in Scotland