In October 2020, digital health applications (DiGAs) became part of standard care in Germany. For approval, DiGA manufacturers must demonstrate medical benefit or patient-relevant improvement of structure and processes (PISP). PISP refers to an innovative outcome core area in terms of proof of benefits and reimbursement decisions. These are subdivided into 9 outcome domains, including for example health literacy, facilitating access to care, and coping with illness-related difficulties in everyday life. Their implementation aims at empowering patients, encouraging shared decision-making, and increasing patient-centeredness in healthcare delivery. Given the novelty of PISP, no standardized set of outcomes and outcome measurement instruments currently exists to operationalize the domains. Learning from previous evaluation studies can help operationalize and standardize PISPs for evaluation studies of digital health applications. Therefore, we investigated the outcomes and outcome measurement instruments, used in controlled trials to assess DiGA-compliant applications, published before the Digital Health Applications Ordinance of April 2020.