title: Policy Making in Newborn Screening Needs a Structured and Transparent Approach.
abstract: OBJECTIVE
  Newborn bloodspot screening (NBS) programs have expanded significantly in the past years and are expected to expand further with the emergence of genetic technologies. Historically, NBS expansion has often occurred followingad hocconsideration of conditions, instead of a structured and transparent approach. In this review, we explore issues pertinent to NBS policy making, through the lens of the policy cycle: (a) agenda setting, (b) policy advice, (c) policy decision, (d) implementation, and (e) evaluation.
  
  
  METHODS
  A literature search was conducted to gather information on the elements specific to NBS and its policy making process.
  
  
  RESULTS
  The review highlighted two approaches to nominate a condition: a structured approach through horizon scanning; and anad hocprocess. For assessment of a condition, there was unanimous support for a robust process based on criteria. While the need to assess harms and benefits was a repeated theme in the articles, there is no agreed-upon threshold for benefit in decision-making. Furthermore, the literature was consistent in its recommendation for an overarching, independent, multidisciplinary group providing recommendations to government. An implementation plan focusing on the different levels on which NBS operates and the information needed on each level is essential for successful implementation. Continuously monitoring, and improving a program is vital, particularly following the implementation of screening for a new condition. An advisory committee could advise on implementation, development, review, modification, and cessation of (parts of) NBS.
  
  
  CONCLUSIONS
  The results highlight that there are a wave of issues facing NBS programs that policy makers must take into account when developing policy processes. What conditions to screen, and the technologies used in NBS, are both up for debate.
authors.affiliation: Section Community Genetics, Department of Clinical Genetics, Amsterdam Public Health Research Institute, Amsterdam, Netherlands; Institute for Public Health Genomics, School for Oncology and Developmental Biology (GROW), Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, Netherlands.
authors.forename: Marleen E
authors.initials: ME
authors.lastname: Jansen
authors.affiliation: Screening Policy Section, Office of Population Health Genomics, Department of Health, Government of Western Australia , Perth, WA , Australia.
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Lister
authors.affiliation: Institute for Public Health Genomics, School for Oncology and Developmental Biology (GROW), Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, Netherlands; Center for Nutrition, Prevention and Health Services, National Institute for Public Health and the Environment, Bilthoven, Netherlands.
authors.forename: Henk J
authors.initials: HJ
authors.lastname: van Kranen
authors.affiliation: Section Community Genetics, Department of Clinical Genetics, Amsterdam Public Health Research Institute , Amsterdam , Netherlands.
authors.forename: Martina C
authors.initials: MC
authors.lastname: Cornel
keywords: decision making; genetic testing; genomic screening; newborn screening; public health policy