Cycle Apps Face Scrutiny as Femtech Market Booms: Data Privacy and Efficacy concerns Rise
BERLIN – The rapidly expanding market for “Femtech” – technology focused on women’s health – is prompting calls for greater scrutiny of cycle tracking and other health apps, particularly regarding data protection and the validity of their claims. While offering potential for scientific advancement through data collection,experts warn users to carefully evaluate app origins and privacy policies.
The proliferation of apps targeting menstrual health, fertility, and overall wellness has created a crowded marketplace where distinguishing between beneficial tools and less reliable options is challenging. “With the apps on the free market, it is difficult to say in general whether they have a benefit or not,” says Carina Vorisek. A key concern is the representation of founders; Vorisek notes, ”What always scares me a bit personally is when the founders of a FemTech company are mainly male.”
Certification offers one avenue for assessing an app’s credibility. Apps published by health insurance companies or classified as “digital health treatments” face notable regulatory hurdles, requiring proof of benefit.
However, data privacy remains a paramount concern, especially given the sensitive nature of the data collected. The use of cycle apps in legal investigations – as seen in the USA following the overturning of Roe v. Wade,where data was leveraged to pursue cases related to illegal abortions – highlights the potential risks.
Germany has implemented stricter data protection regulations through the Digital Health Applications Ordinance (Digav), mandating standards for information security, purpose binding, data minimization, and user education. The General Data Protection Regulation (GDPR) also applies to apps used within Germany, even those originating from countries like the USA.
A critical distinction exists between medical devices and lifestyle products. While medical apps are subject to rigorous testing, cycle apps designed solely for cycle observation are currently classified as lifestyle products and do not face the same stringent requirements. Users are therefore advised to verify an app’s origin and the applicable regulations before use.
