I read that countless numbers of people are worried about being regulated by government in any reformed health system.   But no one, especially policymakers, seems to be addressing the regulatory infrastructure and the costs of regulation, which might open up a pandora’s box and really shed light on the extent to which the public is benefiting from the regulations developed to protect the American people (which is an issue for a longer discussion).  No one is asking whether the agencies mandated to regulate, including the Centers for Medicare & Medicaid Services,  have the resources to address implementation and enforcement of current and new regulations.  Policymakers should be addressing those resources now.  Policymakers would also do well to look at the costs of compliance for the government and for health care providers.   A 2005 study by the Association of Academic Health Centers  found that the costs of compliance  increased up to 300% in the previous decade and often more than 70% a year at academic health centers throughout the nation. We are hearing of even greater increases at the present time.  No one is denying the need for accountability and protecting quality, safety, and privacy in the health care arena.  But it may be time for the government to ask about the costs and benefits of regulation along with addressing the need for rational and ”smart” regulations.  There is also an urgent need for harmonization within the regulatory environment.  Interagency task forces have done little to ensure there is no contradiction and confusion between regulations coming out of the many government agencies.  If we really want to ensure safety and quality for the public as well as savings in health care delivery, reform of the regulatory world must be addressed now.