The practice of medicine has accepted the obligation for evidence-based decision-making (EBDM) and has begun implementation. The rationale for requiring EBDM seems equally valid for, but unused by, the managers and the regulators of healthcare. Unintended and adverse consequences often occur after management decisions and passage of healthcare regulations. Examples are given including fixing an OR budget and HIPAA. Logic is an insufficient substitute for proof-of-effect. Costs of regulation—all unfunded—are related to: compliance; inefficiency; adverse impacts; protectionism; and non-financial elements. A valid cost/benefit analysis is currently impossible because a generally accepted calculus of “benefit” is lacking. For example, timeline of expenses is in months but timeline of medical benefits is in decades. We track and measure what we do not want, i.e., death and in-hospital stay, rather than what we do want: health, longevity and function. In medicine, root cause analysis (etiologic diagnosis) leads to recommendations (therapeutic options). 1) Develop consensus on desired outcomes. The public MUST be part of this dialogue. 2) Create appropriate cost/benefit metrics, with specific attention to time horizons. 3) Implement EBDM in all three aspects of healthcare: practice, management and regulation. 4) Consider mandating a R.I.R. (regulatory impact report) before passage of regulations effecting healthcare. 5) Apply systems thinking to the decision-making process.
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