7. Incorporation of patient generated data and PROs: Patient generated data and PRO collection is an important priority of the FDA and other regulators, for safety and efficacy in medical devices.k Patients can contribute is by serving as partners, participating in research and surveillance, and sharing their experience related to devices. Robust and comprehensive patient generated, and PRO data collection is possible when combined with use of mobile applications, advancement in EHR systems and linkages to EHRs and registries.l
The PRO measures should include collecting at least one general health and one disease- specific outcome measure. Centre for Devices and Radiological Health at the FDA defines the PRO as a measurement based on a report that comes directly from the patient (ie, study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.	Level 1 Early Learner	The CRN identified (ideally with patient engagement) and collaborated with stakeholders to define disease specific and general health validated PROs that meet regulatory guidelines.
	Level 2 Making Progress	In addition to level 1, the CRN conducted a demonstration project of obtaining PROs and integrating within CRN infrastructure.
	Level 3 Defined Path to Success	In addition to level 2, the CRN is able to seamlessly integrate PROs within CRN infrastructure using patient- facing applications.
	Level 4 Well Managed	In addition to level 3, the CRN is routinely obtaining PROs using a consecutive and generalizable sample and using these for research and surveillance and has conducted at least one study using PROs for a benefits and harms assessment of technologies.
	Level 5 Optimised	In addition to level 4, the CRN is routinely obtaining PROs on a large scale to allow benchmarking at the participating institutional level and has substantial experience of using PROs for a benefits and harms assessment of technologies.
KValue and Use of Patient Reported Outcomes (PROs) in Assessing Effects of Medical Devices. CDRH Strategic Priorities 2016- 2017 https://www.fda.gov/files/about20fda/published/Value-and-Use-of-Patient-Reported-Outcomes-28PROs29-in- Assessing-Effects-of-Medical-Devices.pdf. Accessed 04/09/2021.
lWu AW, Kharrazi H, Boulware LE, Snyder CF. Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research. J Clin Epidemiol. 2013;66(8 Suppl):S12-20.