Informed Consent

Background
Patient consent is a central part of medical and research ethics and ruled by international human rights law. Behind the term there is a jungle of regulations, rulings, formal demand conditions, but operationally it is often impractical because patients don’t understand the full implications of what they are consenting to. Data relating to consent are in my experience not accessible in a useful way for patients or carers.
Problem
Developments in digital care and the use of big data also require consent. With these tools it is often difficult to obtain consent, which can be validated, e.g. with a signature, or check whether the patient has really understood what consent is being granted (e.g. the patient may be unable to give consent: PTSD, unable to read well, mental disorder, intoxication, severe sleep deprivation, etc.) Valid, informed consent is however central to patient empowerment.
Actual Challenge
How to obtain valid, informed consent from patients with digital applications?
Roles
Patients, Communication specialists, Legal experts, Medical experts