Technically advanced. Built for safety.

✔ HIPAA compliant
✔ Concerning language detection
✔ IRB review for all clinical studies
✔ DHAF safety rating (ORCHA)
✔ Mozilla privacy rating
✔ SOC 2 Type 2 examined with zero exceptions

Safety isn’t just a priority at Woebot Health, it’s the foundation of our entire business. We can only help people if they trust us. So we take safety, privacy and security very seriously.

Our safety focus is on the people who use our solutions, and it’s evident in all we do, from the way we develop and test products to the way we strive to protect user data.

Our core beliefs guide our practices, and our Privacy Policy, which has been lauded by Mozilla for its clarity and comprehensiveness, provides further insights into how we operate. But here are some fundamental things you need to know about our solutions, our company, and our approach.

  • Conversations with Woebot are developed by conversational experts with clinical oversight. Woebot gives users the opportunity to share about what they’re feeling, and then leverages natural language processing to interpret those inputs and identify which expert-crafted intervention would be most beneficial in that moment.
  • Woebot is trained to detect concerning language during a conversation. Woebot is not a crisis service, but its natural language processing algorithm, developed in collaboration with clinical psychologists and continually monitored and tested for accuracy, is able to detect potentially concerning language. When it does, Woebot immediately offers people the option to view information about external resources for further help.
  • We safeguard all user data as Protected Health Information (PHI) and adhere to all HIPAA requirements. We do this even when the data is not legally classified as such. We also secure sensitive data in a dedicated environment for clear access control, and we’re assessed by an external party every year to ensure we’re compliant. These are rigorous, clinical-level protocols we choose to take on for the sake of privacy.
  • We do not share or sell user data to advertising companies or for advertising purposes. We didn’t do it when we introduced Woebot six years ago. We don’t do it now. We will never do it. 
  • Our Safety Assessment Committee represents a cross section of clinical, regulatory and medical experts and ensures robust safety surveillance of each solution during clinical development.
  • Our Clinical Team stays at the forefront of science, and transparency. Woebot Health studies are reviewed by an institutional review board (IRB) to ensure our methods of research are ethical. We also register our trials, regularly publish protocols, and openly share our results. These practices have helped push the entire field forward, and made Woebot the most evidence-based mental health chatbot in the world, and Woebot Health the single most mentioned digital therapeutics company in the peer-reviewed scientific literature today.

Independently rated for safety, privacy and security

Our products and company have been recognized by the most important ratings organizations in the world:

  • Developed by the American Institute of CPAs (AICPA), System and Organization Controls (SOC) 2 is a voluntary compliance standard for service organizations which specifies how organizations should manage customer data. Woebot Health undergoes audits by an external authorized audit firm for their SOC 2 Type 2 + HIPAA Compliance Report. The report deems our controls acceptable for the Trusted Criteria of Security, Confidentiality, and Availability +HIPAA with no exceptions. 
  • ORCHA DHAF: The Digital Health Assessment Framework (DHAF), which Woebot has passed, assesses safety, efficacy, privacy and security in digital health technologies. Developed by the Organization for the Review of Care and Health Apps (ORCHA) with The American College of Physicians (ACP) and the American Telemedicine Association (ATA), the framework helps healthcare professionals and patients make more informed decisions about which tools best suit their needs.*, **, ***

About regulation

Millions of people around the world are already using a mental health app, even though to date there has been no clear way to determine whether a product is safe to use, and many apps fall outside of existing medical device regulations and federal laws. 

With newer AI-based technologies spurring even more interest in digital solutions, it’s a growing challenge for health systems and individuals to accurately assess their benefits and weigh concerns about safety, privacy and security. 

We believe in regulation. That’s why we’re doing the hard work to maintain an effective and compliant QMS. Our regulatory compliance team doesn’t just know the FDA; they actually come from the organization. It’s the rigor needed to develop and deliver AI innovation safely, and ethically. 

As we explore new technologies like large language models, we’re keeping safety front and center. We’re leaning into innovation in a controlled way so that we can take emerging technology and apply rigorous user research, engineering, clinical and therapeutic oversight to create impactful, safe and well evidenced products. That will help us all develop a future where the freedom to innovate is well balanced by the need to be responsible, and where AI is optimized for a healthier humanity. Learn more about our innovation with LLMs.

*Woebot for Adults is not evaluated, cleared or approved by FDA. It may be considered as an adjunct to clinical care, it does not replace clinical care.
**Woebot does not provide crisis counseling and is not a suicide prevention or crisis intervention service. Concerning language is not reviewed or assessed internally at Woebot Health in real-time for intervention and such data is not used for managing potential crises or any acute or non-acute patient safety issue. Discomfort may be experienced when answering sensitive questions. Temporary upset may occur as a result of discontinued access to the Woebot for Adults, Woebot for Adolescents and Woebot for Maternal Health solutions.
***ORCHA does not follow the Federal Food, Drug, and Cosmetic Act and therefore ORCHA certification does not denote clearance or approval by the U.S. Food and Drug Administration (FDA). Woebot for Adults, Woebot for Adolescents and Woebot for Maternal Health have not been evaluated, cleared, or approved by FDA.