Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation

Area of Science:

• Digital Medicine
• Mobile Health Applications
• Health Technology Assessment

Background:

• Smartphones provide unprecedented opportunities in digital medicine due to their accessibility and potential for insights into behavior.
• The rapid development and dissemination of digital health resources outpace their evaluation for efficacy, safety, and security.
• Patients and clinicians face challenges in identifying beneficial digital health tools from potentially harmful ones.

Purpose of the Study:

• To propose a novel approach to enhance the transparency and safety of mobile health applications.
• To address the limitations of current regulatory efforts in evaluating rapidly evolving digital health tools.
• To incentivize the development of secure and effective medical applications.

Main Methods:

• Proposing a dynamic self-certification checklist for mobile health applications.
• Outlining a system where app users can validate or challenge self-certifications.
• Suggesting a complementary approach to existing regulatory frameworks.

Main Results:

• The proposed checklist would enhance transparency in the digital health market.
• User validation and challenges would foster meaningful stakeholder engagement and education.
• Self-certification would incentivize developers to prioritize safety and security in medical apps.

Conclusions:

• A dynamic self-certification checklist offers a practical method to improve the safety and transparency of digital medicine.
• Engaging app users in the validation process is crucial for building trust and accountability.
• This approach complements existing regulatory measures, promoting responsible innovation in mobile health.