Hans van den Heuvel

11 Risks of early, unevaluated implementation of digital health There is paucity of data on telemonitoring of fetal condition in high-risk pregnancy (Chapter 2 and Chapter 10). To date, no prospective or randomized controlled trials are performed to assess clinical and cost-effectiveness or perinatal outcomes of a monitoring strategy using home cardiotocography tracings. While multiple systems are (being) developed and tested for feasibility and usability, safety issues remain unclear. Our research group favours innovation of care, using telemedicine, for the pregnant population. Therefore, we are strongly committed to evaluate its impact before wide implementation in clinical practice. Possible risks associated with early implementation of unevaluated digital health include usability problems, issues regarding safety and reimbursement, and possible adverse perinatal outcomes, resulting in disappointing adoption by the end-users. To compare safety, satisfaction and cost-effectiveness of traditional HOspital care versus daily TELemonitoring at home for complicated pregnancies; we set up the multi-center randomized controlled HOTEL trial (Chapter 10). Pending the fulfilment of inclusions of our on-going trial in 6 Dutch obstetric units, a number of hospitals choose to implement telemonitoring as standard care for high-risk pregnancy. We performed a survey inDecember 2018, which revealed that 17 hospitals (representing 23% of all 73 hospitals offering obstetric care in The Netherlands) now work with pregnancy telemonitoring (chapter 9). Of these 17 centers, 59% reported they have never performed an evaluation of results before implementation in practice, while the other participate in the trial. Figure 1 shows that the use of pregnancy telemonitoring continues to grow, yet without proven value and safety for the patient. Figure 1 Trend graph of Dutch centres offering home- and telemonitoring in high-risk pregnancy. SUMMARY AND GENERAL DISCUSSION 183