Abstract
Background Health data personally collected by individuals with wearable devices and smartphones is becoming an important data source for healthcare, but also for medical research. Objective To describe a new consent model that allows people to control their personally collected health data and determine to what extent they want to share these for research purposes. Methods We developed, in close collaboration with patients, researchers, healthcare professionals, privacy experts, and an accredited Medical Ethical Review Committee, an innovative concept called “personalized consent flow” within a research platform connected to a personal health record. The development was an iterative process with informal meetings, semistructured interviews, and surveys. The final concept of the personalized consent flow was reviewed by patients and improved and approved by the same patients in a focus group. Results This concept could result in optimal control for individual users, since they will answer questions about how they will share data. Furthermore, it enables users to collect data for specific studies and add expiration dates to their data. This work facilitates further discussion about dynamic and personalized consent. A pilot study with the personalized consent model is currently being carried out.
Highlights
A growing number of individuals use smartphones, tablets, and other wearable devices to measure health parameters, symptoms, and lifestyle factors
We propose an innovative concept called “personalized consent flow” together with a research platform connected to a personal health records (PHR) to meet all characteristics of contemporary data collection and data sharing
Rake) and discussed with a second author (Tom H. van de Belt) with expertise in qualitative research. These two information sources lead to identification of the fits and gaps related to ethics and regulations and the current situation regarding medical ethical research committees, consent, and research compared to the future situation using the research platform of HIMD
Summary
Health data personally collected by individuals with wearable devices and smartphones is becoming an important data source for healthcare, and for medical research. To describe a new consent model that allows people to control their personally collected health data and determine to what extent they want to share these for research purposes. In close collaboration with patients, researchers, healthcare professionals, privacy experts, and an accredited Medical Ethical Review Committee, an innovative concept called “personalized consent flow” within a research platform connected to a personal health record. This concept could result in optimal control for individual users, since they will answer questions about how they will share data. It enables users to collect data for specific studies and add expiration dates to their data. A pilot study with the personalized consent model is currently being carried out
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
