Navigating the Future of Digital Health: Building a Non-Medical Device AI Health Coach Chatbot

In the rapidly evolving landscape of digital health, the intersection of technology and wellness presents both opportunities and regulatory challenges
As we develop innovative solutions like generative AI chatbots to support patients on their behaviour change journeys, it's crucial to design these tools carefully to ensure they provide value without inadvertently crossing into medical device territory.
Here are 6 key principles we're following at Dr Sacher & Co. to achieve this balance:
1. Focus on Health Coaching: Our chatbots provide general advice on behaviour change, motivation, accountability, and share information on health, nutrition, and wellness, offering 24/7 support, enabling just in time adaptive interventions (JITAI) and support rather than offering personalised medical advice.
2. Transparency and Disclaimers: We emphasise that our chatbots are a supplementary tool for support, motivation and information, not a replacement for professional healthcare advice. Patients tell us they value the ability to communicate anonymously with a chatbot who replies immediately, but also knows when to handover to a human healthcare professional.
3. Engagement Without Diagnosis: Our chatbots are crafted to motivate and monitor progress towards healthier habits, without offering diagnoses or treating conditions. Through establishment of stringent safeguards and continuous testing, we ensure that chatbots refrain from delivering personalised diagnoses or medical advice.
4. Limiting Claims about Health Outcomes: We're cautious about making claims on the efficacy of the chatbots in improving health outcomes. Avoiding suggestions of medical benefits helps us steer clear of regulatory scrutiny. Focus instead on qualitative feedback and quantitative benchmarking of quality, safety and accuracy.
5. Privacy as a Priority: We commit to the highest data privacy standards, safeguarding patient information and upholding their trust along with regulatory demands. By securing proper consents, we guarantee that patients are fully informed and consent to interactions with an AI chatbot, including the sharing of necessary information with their healthcare providers
6. Staying Informed: We commit to continuous learning and adaptation, ensuring our solutions align with evolving health tech regulations and best practices.
By establishing these guardrails, we provide a supportive, motivational tool for those seeking to improve their health and wellness. This approach allows us to navigate the regulatory landscape responsibly while innovating in the digital health space.
We're excited about the possibilities this brings to the digital health and wellness community.
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