REFERENCES
- Aguilar, M. 2022. Mental health tech startups have ideas. Now, to build business, they need evidence. STAT News, March 1. https://www.statnews.com/2022/03/01/mental-health-tech-evidence-digital-therapeutics.
- Goldberg, S. B., S. U. Lam, O. Simonsson, J. Torous, and S. Sun. 2022. Mobile phone-based interventions for mental health: A systematic meta-review of 14 meta-analyses of randomized controlled trials. PLoS Digital Health 1 (1):e0000002. doi:https://doi.org/10.1371/journal.pdig.0000002.
- Koch, M. C., J. Lermann, N. van de Roemer, S. K. Renner, S. Burghaus, J. Hackl, R. Dittrich, S. Kehl, P. G. Oppelt, T. Hildebrandt, et al. 2018. RETRACTED ARTICLE: Improving usability and pregnancy rates of a fertility monitor by an additional mobile application: Results of a retrospective efficacy study of Daysy and DaysyView App. Reproductive Health 15 (1):37. doi:https://doi.org/10.1186/s12978-018-0479-6.
- Koch, M. C., J. Lermann, N. van de Roemer, S. K. Renner, S. Burghaus, J. Hackl, R. Dittrich, et al. 2019. Retraction Note: Improving Usability and Pregnancy Rates of a Fertility Monitor by an Additional Mobile Application: Results of a Retrospective Efficacy Study of Daysy and DaysyView App. Reproductive Health 16 (1):54. doi:https://doi.org/10.1186/s12978-019-0728-3..
- Polis, C. B. 2018. Published analysis of contraceptive effectiveness of Daysy and DaysyView App is fatally flawed. Reproductive Health 15 (1):113. doi:https://doi.org/10.1186/s12978-018-0560-1.
- Sheridan, K., and C. Ross. 2022. In a defamation lawsuit, the hype around digital health clashes with scientific criticism. STAT News, March 2. https://www.statnews.com/2022/03/02/health-fertility-thermometer-valley-polis/.
- Skorburg, J. A., and J. Yam. 2022. Is there an App for that?: Ethical issues in the digital mental health response to COVID-19. AJOB Neuroscience 13(3): 177–190. doi:https://doi.org/10.1080/21507740.2021.1918284.
- U.S. Food and Drug Administration. 2019a. General wellness: Policy for low risk devices guidance for industry and food and drug administration staff. https://www.fda.gov/media/90652/download.
- U.S. Food and Drug Administration. 2019b. Policy for device software functions and mobile medical applications guidance for industry and food and drug administration staff. https://www.fda.gov/media/80958/download.
- U.S. Food and Drug Administration. 2020. Enforcement policy for digital health devices for treating psychiatric disorders during the coronavirus disease 2019 (COVID-19) public health emergency. https://www.fda.gov/media/136939/download.
- Valley Elecs. AG v. Polis, No. 21-2108-CV, 2022 WL 893674 (2d Cir. Mar. 28, 2022).