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Last week, World Menopause Day spotlighted a critical issue impacting half the population. The UK government estimated menopause costs the UK economy 14 million working days annually due to women taking time off due to some of the debilitating symptoms. These include hot flushes, insomnia, low mood and/or anxiety, problems with memory and concentration, and migraines.  Women globally are desperately seeking solutions. A recent consumer report cited 34% of women view vitamins and supplements as a “top treatment and preventative approach“.[1] The demand for other solutions is high.

Enter FemTech: technology specifically created for women. More specifically, technology poised to revolutionise menopause care with personalised healthcare solutions. Despite only 5% of FemTech start-ups focusing on menopause, those that leverage compliance as a catalyst for innovation could gain considerable market share.

So, what are some of the key regulatory considerations applicable in this space?

  • New legislation, guidance and standards applicable to AI;
  • Data Privacy, Cyber and Data Protection;
  • Medical Device Regulations and Product Liability considerations;
  • Marketing and Advertising Standards and other Intellectual Property considerations; and
  • Subscription-Based Business Model Consumer Requirements.

How can a FemTech company build consumer trust in this space?

To build consumer trust, FemTech companies should prioritise transparency by communicating how they use and share data. Privacy policies and pricing approaches must be understandable, particularly for advertising purposes. Avoid hidden surprises in terms of data sharing. And take steps when sharing data to protect designs and commercially sensitive information. We’ve considered each theme in more detail below.

  • Impact of Generative AI: Enhancing Personalization and Health Equity

Generative AI is revolutionizing the FemTech sector by enhancing personalization in health solutions. It can cater to individual needs and address health equity issues. Despite historical underinvestment, AI’s ability to process large data can help bridge knowledge gaps in women’s health.

The use of AI and telemedicine in FemTech increases access to quality healthcare, reduces societal stigmas and empowers women to close the gender gap in healthcare. The use of wearable FemTech – powered by AI – to tackle menopause can significantly improve health using at-home hormone monitoring. This can lead to quicker and more accurate diagnosing and the easing of everyday symptoms.

The leap in technology isn’t without its challenges. The demand for extensive data required to train GenAI models has complex requirements. Synthetic data will play a crucial role. Also, the risk of errors necessitates vigilant oversight and clear communication to retain consumer trust. Governance will be key.

  • Data Protection and Privacy Laws

FemTech companies face significant challenges in complying with evolving global data protection and privacy laws. FemTech apps and devices collect sensitive personal information, such as body temperature fluctuations, metabolic changes and menstrual cycle details. This must be handled with utmost care and ensuring robust data protection mechanisms is essential. The Data (Use and Access) Bill was introduced to the UK Parliament on 23 October 2024. It purports to unlock the secure and effective use of data for the public interest, so watch this space as the bill evolves as it will impact the sharing of health data.

Companies often claim data is anonymized and used only for research or improvement, but the distinction between “anonymous” and “pseudonymized” data is often misunderstood. This risk the potential for misuse.

Navigating international privacy regulations requires FemTech companies to adapt their policies to meet different standards globally. This becomes harder when some products are classified as medical devices, which have their own requirements. Effective data protection measures can help companies build trust and solidify their reputation as reliable health technology providers.

  • Medical Device Regulations

FemTech medical devices with a “medical purpose”, such as biometric tracking apps and vasomotor (the regulation of blood flow) treatment devices face significant scrutiny in the EU and must adhere to stringent Medical Device Regulation (MDR) standards. The introduction of the EU AI Act adds further complexity, imposing stricter regulations on AI systems used in FemTech products that are medical devices.

Ensuring product quality and accuracy is crucial for user safety. FemTech companies must prioritise this due to the serious repercussions of defects, such as legal claims and customer dissatisfaction.

Compliance is crucial to avoid penalties and potentially to allow consumers to claim products on health insurance. Though, even if challenging, balancing innovation with regulatory adherence is essential for building trust and creating meaningful health solutions for women.

  • Marketing & Advertising Standards and other IP considerations

Alongside regulatory compliance, advertising standards represent another crucial area for companies to navigate. Marketing and advertisement claims must be neither false nor misleading. For example, a product claiming to be an “effective hot flush treatment,” must truly deliver or risk litigation due to false advertising or unfair business practices. Ensuring compliance with these regulations often requires substantial investment in product research and development, which is often the Achilles heel of many startups.

Companies developing FemTech products should also be careful to protect their intellectual property (IP). By securing patents and trademarks, companies can safeguard their unique solutions, encouraging further investment. Additionally, robust IP protection helps prevent unauthorized use or replication. And ensures that the original creators receive recognition and financial benefits for their innovations. Get the basics of your non-disclosure agreements right and proper data-sharing terms in place. This not only promotes fair competition but also drives continuous improvement in FemTech products, benefiting female health and well-being globally.

  • Subscription-Based Business Models

Many FemTech applications use subscription-based business models, which have faced criticism in the UK due to hidden recurring payments. New laws now require transparency about automatic renewals and introductory offers. Take steps to inform customers.

Building Trust in FemTech

FemTech has the potential to revolutionize women’s health by providing personalised care and specialised solutions while maintaining user trust and security. Building trust is crucial as the industry grows and innovates. Given the numerous regulatory challenges, particularly around data privacy, both companies and consumers are understandably cautious. Companies must navigate evolving regulations to ensure their products are effective and legally compliant.

[1] Source: Euromonitor International’s Voice of the Consumer: Health and Nutrition Survey, fielded February 2024