Participants of the Seminar on Ethics in Digital Health convened in July and November 2018 with the goal of putting forward an initial set of guiding principles that could be used to initiate discussion and build support for a cross sector agreement on principles related to digital health products and services.
This effort will continue to evolve as feedback is received, new issues surface and new participants join the conversation. The framework for the seminars were as follows:
- These principles address the ethical use of digital health products and information.
- A “digital health product” is a commercially marketed device, app, medicine or other offering that is promoted based on claims to improve human health outcomes, and which collects and generates digital health information.
- “Digital health information” is all information collected and generated by a digital health product that is connected to the Internet.
- This Statement begins to define principles for digital health companies to ensure the ethical use of their products and the information they collect and generate.
- These principles should neither replace nor be replaced by:
- the obligations of digital health companies to regulatory agencies and other government bodies that may control health standards
- all applicable laws and regulations where digital health companies choose to operate
- These principles should help digital health companies navigate potential conflicts between individuals’ need for privacy and society’s need for protecting public health:
- sharing anonymized health information can be beneficial to individuals and populations, such as in cases of controlling disease outbreaks and discovering cures to conditions without adequate treatments.
- but sharing health information can also lead to risks for individuals and populations, requiring patients, health care providers, regulators, policy makers and bioethicists to work together to create trusted solutions.
- Investigational products or those being used in clinical trials may be covered by this Statement, but the protocols and rules governing them take precedence.
- There will always be situations when the principles in this Statement are insufficient to navigate particular conflicts. For these situations, digital health companies should take advice from qualified bioethicists.
- Digital health companies commit to updating and improving the Stanford Statement of Guiding Principles for Ethics in Digital Health based on feedback and issues raised by the communities they serve; these changes should be shared widely.
- As part of these ongoing efforts to improve transparency and establish clear norms for ethics in digital health, companies will collaborate to create a voluntary certification program based on auditable standards and administered by a notified body such as the Industrial Engineering Council (IEC) or British Standards Institution (BSI).
- Digital health companies will pro-actively work with regulators, State and Federal authorities to develop appropriate new guidelines and laws designed to promote improved health outcomes for both individuals and society at large; these too should be shared widely.