Construct medical research approval systems that do not place an undue burden on providers and researchers. Promote a cost-effective health care system by permitting device manufacturers to collect the information they need for coverage and reimbursement determinations. We recognize the difficulties associated with developing privacy standards and acknowledge that HHS has made a considerable effort toward ensuring that patient safety, the quality of care and medical research remain unaffected. Nevertheless, we believe this rule still has many shortcomings. There are numerous requirements that are unrealistic and will not meet the needs of a health care system that is far more complex than that contemplated by the proposed regulation or the statute.
Many items are ambiguous or require much more explanation and clarification.
Taken together, the shortcomings of this confidentiality regulation create concern from our perspective about the safety and quality of patient care, and our ability to collect data to support medical research. We believe these problems must be addressed in a satisfactory manner before this regulation is implemented. We are pleased to have the opportunity to share with the H.E.L. P. Committee the following concerns about the HHS privacy regulation. The regulation contains substantive changes from the proposed regulation, including new sections and requirements that were neither in the proposed regulation or foreseeable by those commenting on the proposed regulation. A new public comment period for these major new sections of the regulation should be introduced.