title: Setting health standards for the 21st century.
abstract: OBJECTIVE
  To describe the nature, substance, and impact of health standards and to speculate on how they may change during the early years of the 21st century.
  
  
  CONCLUSIONS
  The health care system has experienced dramatic changes over the past three decades. Health standards now cover the spectrum from statutes to regulations to guidelines, as well as less compulsory forms, and address every aspect of health, including the availability, quality, and cost of services; the safety, efficacy, and quality of products; the adequacy of processes and analytic methods; and the value and cost-effectiveness of health technologies and services. Standards cover promotion, protection, and gatekeeping functions. They are established in response to specific needs and are driven by social and political agendas; social policy will drive standards development to a greater extent in the 21st than in the 20th century. Technology advances are stimulating new forms of standards, primarily gatekeeping standards. Standards raise the question of compliance. The trend is increasingly toward less compulsory, more discretionary standards, with a greater percentage being established by quasi-official and voluntary bodies.
  
  
  CONCLUSIONS
  21st century health standards must balance the rights of access with protection from unsafe, ineffective, and poor quality products and services during a period when decisions must be made faster. They must be more flexible, enabling consumers to choose their level of protection. Such standards will pose the same concerns about adequacy, equity, and freedom of choice as health standards pose now. Whether we will use 21st century standards to improve and advance our health as well as systems, products, and services that contribute to health more effectively than we have in the 20th century is a question to ponder.
authors.affiliation: U.S. Pharmacopeial Convention, Rockville, MD 20852, USA. jah@usp.org
authors.forename: J A
authors.initials: JA
authors.lastname: Halperin
mesh_terms: D005544:Forecasting; D006285:Health Planning / Q000639:trends*; D006291:Health Policy / Q000639:trends*; D006293:Health Promotion / Q000592:standards*; D006801:Humans; D008329:Managed Care Programs / Q000639:trends*; D019984:Quality Indicators, Health Care; D014481:United States