be in place. There needs to be clear details and transparency about who is part of the governance structure and what each person's responsibilities entail.

Clear purpose for using PGD Participants believe that this standard will ultimately come down to risk vs. benefit. The risks that individuals may face by consenting to have their data used could be offset by the benefit it brings to themselves and/or to others. Some patients at the workshop expressed that they would not be bothered if their data was used for different purposes than previously expressed and agreed upon as long as they received an alert about it. However, the group pointed out that each patient would have a different level of security that they're willing to tolerate. Ultimately, there may need to be standardized categories for levels of risk, to enable people to choose their level of risk, and then tailor their options according to their chosen risk level. For example, one can opt in to have their PGD used for research, but opt out to have it used for quality improvement. However, there cannot be too many categories which could become overwhelming and possibly even alarming for some people. One group suggested that preferences should be listed in clusters of four or five, and that this risk level be chosen via consent forms. Ultimately, there was consensus that there cannot be too strict a purpose for the data. Otherwise, it would make it very difficult to make it available for future or other use.

Selection of PGD data in consultation with patient/caregiver partners Participants pointed out that this standard was very similar to the first standard, ' involvement of patients/caregivers' and should perhaps not be included as a separate standard. Instead, the description of the first standard could be elaborated to include this information.

Easy collection and use of PGD Participants agreed that the focus should be on reducing patient burden and ensuring that the tools being used are proactive. The group also identified data overload as being a key challenge and believe it is crucial that users of PGD do not have an unwieldy amount of data to sift through. They require only the data that is useful and relevant for their purposes, and the tools and techniques that are used should reflect that.

Co-design consent mechanisms in consultation with patient/caregiver partners While there was no disagreement that patient and caregiver partners should be involved in the co- design of consent mechanisms, it was emphasized that the co-design element should be practical and in tune with the patient/caregiver's skillset and expertise. The patient and caregiver roles need to be clearly defined. Ultimately, however, participants had more to say about consent in particular, than the co-design process for consent mechanisms.

While there was no disagreement that there needs to be a consent framework, there was a lot of discussion, and no consensus of what that framework should entail. The consent framework could ask individuals for their patient-generated data immediately, in real time. However, providing consent could also mean that once their consent is given, a person's data may be used later as well.