What is informed consent in Digital Health for Personalised Medicine?
PubGene AS is building Coremine Vitae, a Digital Health solution for Personalised Medicine. It is intended to aid in the personalized, shared clinical decision, finding treatment options for patients and their healthcare teams. It is based on a CE-marked Medical Device MDD Class I, harnessing the powerful combination of human and machine intelligence.
This article is the post number 1 of the series “Solving the data privacy challenge when working with Digital Health and Artificial Intelligence for Personalized Medicine”, originally published on coreminevitae.com/blog/
What is the patient informed consent, how is it regulated?
“ The user consent for the processing of personal data must be free, specific and informed. Explicit consent needs to be obtained for the processing of health data. Any withdrawal of consent has to result in the deletion of the user’s personal data.” Consent shall be “in an understandable and easily accessible form and in a clear and simple language” (cf. Article 7 (2) of the Norwegian Privacy Regulation).
5 bullets points to collect an Informed Consent in practice
- The consent form must be in the national language of the user.
- It must contain the comprehensive list of information that our solution is going to collect.
- It must clearly list all specific purposes for data collection. The user of the service may tick off for which purposes he consents to, or there can be separate consent forms for each purpose.
- Consent for children or persons who do not have consent competence must be handled separately.
- In addition to the consent form, the user must be informed in accordance with the Privacy Regulation Articles 13 and 14. This can be established as a privacy statement on the company website.
What an informed consent form is not (an easy mistake)
Reservations from the company, such as “ (…) is not intended to be a substitute for professional medical advice” or “The information is provided solely for informing the patient about relevant treatment” or “the information does not warrant that any drug identified will guarantee a therapeutic response for the patient”
Reservations/disclaimers that a vendor may have are not part of an informed consent form.
What’s special about informed consent in Digital Health?
The reuse of data for learning purposes must be clearly stated, and it is a good idea to provide an opt-out without preventing users from using the solution. The usage of digital video solution also requires a special consent.
Check out our Coremine Vitae Informed Consent (in Norwegian) and Coremine Vitae Privacy Statement.
We created digital forms timely delivered in a semi-automated step by step guide on our collaboration portal based on Checkware, to facilitate the collection and possible withdrawal of informed consent.
In the next post, I will dive into the practicalities of Code of Conduct and ISO standard in Information Security. If you’re interested in this topic, make sure to follow to be notified! In any case, don’t hesitate to comment if you would like more information about informed consent, or if you’d like to share your experience.
In case you miss the previous posts:
