There are five sections to the act, known as titles.
The Notice of proposed rulemaking  for this law describes the reason Congress passed it. Much of the impetus for this legislation can be traced to the publication of the landmark report, " To Err is Human ",  by the Institute of Medicine in Report.
The Report cited studies that found that at least 44, people and potentially as many as 98, people die in U. One of the main conclusions was that the majority of medical errors do not result from individual recklessness or the actions of a particular group; rather, most errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent adverse events.
Thus, the Report recommended mistakes can best be prevented by designing the health care system at all levels to improve safety—making it harder to do something wrong and easier to do something right.
As compared to other high-risk industries, the health care system is behind in its attention to ensuring basic safety. The reasons for this lag are complex and varied. Providers are often reluctant to participate in quality review activities for fear of liability, professional sanctions, or injury to their reputations.
Traditional state-based legal protections for such health care quality improvement activities, collectively known as peer review protections, are limited in scope: They do not exist in all States; typically they only apply to peer review in hospitals and do not cover other health care settings, and seldom enable health care systems to pool data or share experience between facilities.
If peer review protected information is transmitted outside an individual hospital, the peer review privilege for that information is generally considered to be waived.
This limits the potential for aggregation of a sufficient number of patient safety events to permit the identification of patterns that could suggest the underlying causes of risks and hazards that then can be used to improve patient safety.
Patient safety work product includes any data, reports, records, memoranda, analyses such as root cause analysesor written or oral statements or copies of any of this materialwhich could improve patient safety, health care quality, or health care outcomes, that are assembled or developed by a provider for reporting to a PSO and are reported to a PSO.
It also includes information that is documented as within a patient safety evaluation system that will be sent to a PSO and information developed by a PSO for the conduct of patient safety activities.
However, patient safety work product does not include a patient's medical recordbilling and discharge information, or any other original patient or provider information; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.
Privilege and confidentiality protections[ edit ] Patient Safety Work Product must not be disclosed, except in very specific circumstances and subject to very specific restrictions.
Between the Provider and the PSO — i. From the provider to the PSO, for Patient Safety Activities, and From the PSO to the disclosing provider, for Patient Safety Activities To a contractor of a Provider or a PSO For contracted Patient Safety Activities Contractor may not further disclose, except back to the contracted provider or PSO Among affiliated providers, for Patient Safety Activities From one PSO to another PSO or another provider, if Direct identifiers which are defined in the regulations of any providers, affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members of such providers are removed; and With respect to any Individually identifiable health information within the PSWP, a limited data set also defined by regulation is produced Business operations — A provider or PSO may disclose to attorneys, accountants or other professionals for business operations purposes.
Further disclosure except back to the contracting entity is prohibited Authorized by identified providers — Disclosure is permitted if all identified providers authorize the disclosure. Authorization must be in writing, signed by the provider, and Must state the nature and scope of the disclosure Accrediting bodies e.
Any identified provider agrees to the disclosure; or Direct identifiers of any provider or affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members are removed Nonidentifiable PSWP — May be disclosed The regulations set out specific requirements for "nonidentification.
Food and Drug Administration FDA — PSWP may be disclosed to the FDA By a provider concerning an FDA-regulated product or activity, By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or By a contractor acting on behalf of the FDA or entity for these purposes Law enforcement — PSWP may be disclosed to law enforcement personnel If the information relates to an event that either constitutes the commission of a crime, or for which the disclosing person reasonably believes constitutes the commission of a crime, provided that the disclosing person believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes Criminal proceedings — But only after a court makes an in camera in closed chambers determination that: Safe Harbor — a provider whose workforce member discloses PSWP is not deemed to have violated the Act if that workforce member disclosure does not include written or oral statements that: Assess the quality of care of an identifiable provider, or Describe or pertain to one or more actions or failures to act by an identifiable provider Note: This safe harbor does not apply to the PSO itself — i.
Network of patient safety databases[ edit ] This section is empty. You can help by adding to it.Part one of a two-part series on HIPAA and email. Email has been widely used by both business and the general public for much of the last twenty years, and reliance on .
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