Period-tracking apps pose ‘significant risks' for users, new report finds
Menstrual cycle tracking apps could jeopardize the safety and privacy of users, a new report warns, with personal data commonly sold to companies.
The stakes are high since period tracking apps have soared in popularity and become ubiquitous amid limited access to information, a lack of research and stigma about menstruation health.
A 2024 study estimates that global downloads for the three most popular menstruation cycle tracking apps surpassed 250 million.
Those who use apps that track periods often don't consider the data 'intimate' or commercially valuable, and need more protections from potential abuse of their personal information, according to the report released Tuesday by The Minderoo Centre for Technology and Democracy. MCTD is an independent team of academic researchers at the University of Cambridge in the U.K.
'Menstrual tracking applications turn personal health information into data points to be collected, analyzed, and sold,' according to the report.
Data sold to companies, advertisers
The study noted the apps pose 'significant risks' for users as femtech has become a 'lucrative trend' and the user data is 'extremely valuable' for a wide range of companies, from those that developed the app to big tech firms and advertising industries.
Femtech refers to digital products, services or technologies promoting women's health and wellbeing, with period-tracking apps making up 50 per cent of the US$22 billion market in 2020.
'People vastly underestimate the commercial value of menstrual data and the extent to which it can provide insights into their political preferences, health issues, or reproductive choices,' researchers wrote.
The apps offer a way for users to track daily information on anything related to their menstrual health, such as menstrual cycles, predictions on periods, premenstrual syndrome (PMS), ovulation and fertility.
Security and privacy risks
To add to the concerns, researchers say the apps also pose risks to data security and privacy, noting it's widely used in the online advertising industry.
'Self-tracking data has been used to police people's reproductive choices, to undermine a user's testimony in court, and it can lead to increased vulnerability in intimate relationships, partner violence, risks to job prospects via employer access to CTA (cycle tracking application) data, workplace monitoring, or possible health insurance discrimination,' according to the report.
Meanwhile, the report also referred to 'severe security risks,' noting an example in the U.K. where period tracker data was used to charge women for illegally accessing abortion services.
Are period apps accurate?
The study notes many medical studies showed that the apps 'fail to accurately calculate cycle length or ovulation windows' and additional data from people is often not used to improve predictions. Rather, researchers say the information is 'predominantly a source of value' for the companies.
'With most apps providing no or very little information on how predictions are made, a 2023 study found that some users were encouraged to track more data to fine-tune their predictions and train an imagined algorithm,' it wrote.
While users commonly turn to the apps to help them conceive or prevent getting pregnant, people with irregular cycles or conditions such as poly-cystic ovary syndrome, endometriosis, or premenstrual dysphoric disorder may also use the apps to try to understand their medical issues. Many people use the apps to track their emotions and bodily functions as well.
Recommendations
The report recommends improving health care for and incentivising research on menstrual and reproductive health, such as through cycle tracking companies and research institutes working together. It encourages schools and organizations to help raise awareness about menstrual tracking for all ages.
Additionally, it recommends alternatives, such as public bodies developing apps that are 'trustworthy' and collect data in a 'responsible way.'
The report also calls for stricter regulation of menstrual tracking data as 'sensitive health information' in the United States and tighter enforcement of existing regulations in the U.K. and European Union. It suggests improving security through 'consent options,' clear and accessible privacy policies, and prioritizing data privacy and security in the app design. Apps could be more 'transparent' by providing clear information on how tracking data is used to make predictions, with interface options for those who cannot or do not want to become pregnant.
The report notes that not all women menstruate and not everyone with menstrual cycles is a woman. For instance, it wrote that children and teenagers have periods, trans men can menstruate and trans women can experience symptoms similar to premenstrual syndrome (PMS). Most apps are designed for straight cis women who want to get pregnant, it added.
David Young, a privacy and regulatory law expert in Toronto, told CTVNews.ca in a video interview Monday that Canada's Personal Information Protection and Electronic Documents Act already follows the report's recommendations, though the law is 'not always enforced.'
According to Canada's federal privacy law, an organization must not require individuals to consent to the collection, use or disclosure of their information beyond 'explicitly specified, and legitimate purposes.'
'Assuming those specific and legitimate purposes are the tracking that the individual is seeking by use of the app, then they shouldn't be allowed to also require, as a condition of using the app, that they're going to sell that information to somebody else,' Young said. He noted Canada also faces a problem with companies selling consumers' medical data, including electronic health records.
Young said menstrual-related cycle data is considered 'sensitive personal health information.'
'And that has a very high standard of compliance under any privacy law, meaning that there must be clear ... consent to for whatever uses are going to be made of that information. So it's not something you can just use by way of implied consent.'
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Article content Recommendation based on Phase 3 RATIONALE-315 study, in which TEVIMBRA demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological response Article content If approved, the expanded label builds on TEVIMBRA's momentum in lung cancer with EU approvals already in NSCLC and SCLC indications across both first- and second-line settings Article content Article content SAN CARLOS, Calif. — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. This recommendation is based on the Phase 3 RATIONALE-315 study ( NCT04379635). Article content 'Patients with resectable, early-stage NSCLC face an urgent challenge – despite surgery and current therapies, recurrence rates remain alarmingly high,' said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at the Faculty of Medicine of Universidad Autonoma de Madrid in Spain. 'The significant clinical benefit observed in the RATIONALE-315 study has important implications for patients. If approved, perioperative tislelizumab will offer oncologists a powerful new option to improve outcomes and potentially alter the course of this difficult-to-treat disease.' Article content RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024 1, the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include: Article content Statistically significant and clinically meaningful improvement in MPR and pathological complete response (pCR) rates: 56.2% of NSCLC patients treated with TEVIMBRA in combination with chemotherapy before surgery achieved MPR compared to 15.0% of patients treated with chemotherapy in combination with placebo (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001) 40.7% of patients on the TEVIMBRA-based regimen achieved pCR, compared to 5.7% of patients treated with chemotherapy in combination with placebo (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001) Statistically significant EFS (HR [95% CI], 0.56 [0.40–0.79]; 1-sided P=0.0003) and trend for overall survival (OS) (HR [95% CI], 0.62 [0.39–0.98]; 1-sided P=0.0193) benefits favoring TEVIMBRA in early data. 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Article content 'TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients.' Article content In lung cancer, TEVIMBRA is already approved in the EU for the first-line treatment of patients with squamous NSCLC, for the first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression, for the treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, and as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also approved as a first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, and as a first-line treatment for patients with nasopharyngeal carcinoma (NPC). Article content About NSCLC Article content Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide. 2 In Europe, lung cancer is the third most frequent cancer with 484,306 new cases diagnosed in 2022. 3 NSCLC accounts for 80–90% of all lung cancers 4, of which resectable NSCLC patients at diagnosis represent around 25–30% 5. Article content About TEVIMBRA (tislelizumab) Article content TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. Article content TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Article content Important Safety Information Article content This information is intended for a global audience. Product indications vary by region. Article content About BeOne Article content BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Article content Forward-Looking Statement Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. Article content ______________________________ 1 Yue, D., et al. (2024, March). VP1-2024: RATIONALE-315: Event-free survival (EFS) and overall survival (OS) of neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS in resectable non-small cell lung cancer (NSCLC). Annals of Oncology, 35 (3), 332-333. 2 Bray, F., et al. (2022). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 74(3):229-263. 3 Ferlay, J., et al. (2024). Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. 4 European Society of Medical Oncology. Non-small-cell lung cancer: A guide for patients. 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