Part 2 book “New health technologies - Managing access, value and sustainability” has contents: Ensuring timely and affordable access to medical devices, achieving the promise of precision medicine, digital technology - Making better use of health data. | New Health Technologies: Managing Access, Value and Sustainability © OECD 2017 Chapter 4 Ensuring timely and affordable access to medical devices by Valérie Paris, Luke Slawomirski and Allison Colbert Medical devices cover a wide range of products of varying complexity and clinical risk. Practitioners’ aptitude in using medical devices in clinical settings also varies. Regulation, coverage and funding of devices thus present a considerable challenge for policy makers who need to balance the often competing objectives of safety, effectiveness, equity and timely access. Regulatory requirements for medical devices were historically less stringent than those for pharmaceutical products. This chapter examines the current state of play for medical device regulation (determining the safety, performance and effectiveness for initial market authorisation and postmarket evaluation) and coverage and funding (determining their inclusion in payment schedules and the reimbursement level for their use). It provides a series of recommendations to improve these aspects of regulatory regimes in OECD countries and other health care systems. The chapter also describes the institutional requirements and policy framework needed to enable sound regulatory, coverage and funding decisions. These include governance, information infrastructure and stakeholder involvement. We thank country delegates and experts, as well as BIAC members, for their comments on earlier versions of this chapter and during the expert meeting of 22 March 2016 and the OECD Health Committee meeting of 28-29 June 2016. We acknowledge in particular suggestions and material provided by Ruth Lopert (George Washington University) Stefano Bonacina (Karolinska Institutet) and Iñaki Gutiérrez Ibarluzea (Osteba). 117 4. ENSURING TIMELY AND AFFORDABLE ACCESS TO MEDICAL DEVICES Introduction Medical devices comprise a very broad range of health technologies, from tongue depressors, splints, cannulas and endoscopes, to .
