Patient Safety Data Reporting: Understanding the Proposal of the HHS

This webinar provides attendees an understanding of the rationale for the Patient Safety and Quality Improvement Act (the “Act”) and how the Department of Health and Human Services (“HHS”) intends to implement it, as set forth in HHS’ Proposed Rulemaking. Attendees are introduced to the terminology of the Act and the Proposed Rulemaking as well as the intended flow of the information among entities covered by the Act and Proposed Rulemaking, highlighting potential deficiencies and gray areas. Particular attention is given to examining how the Act and the Proposed Rulemaking interrelate to other state and federal laws, including the Health Insurance Portability and Accountability Act and certain state laws governing the disclosure of some individually identifiable health information. Finally, the program explores how the Act and Proposed Rulemaking would work in various contexts, such as hospital care and research.    

Session Objectives

Upon completion of this webinar, attendees should be able to:        

• Describe the underlying goals for the Patient Safety and Quality Improvement Act and the Proposed Rulemaking as well as possible limitations for achieving those goal.
• Define key terms, such as “patient safety event” and “patient safety work product”
• Summarize the regulatory scheme included in the Proposed Rulemaking, including ramifications for inappropriately disclosing patient safety event information 
• Describe how the Act and the Proposed Rulemaking work in conjunction with the Health Insurance Portability and Accountability Act to guard against the inappropriate use or disclosure of individually identifiable health information
• Recognize the limitations of the Act and the Proposed Rulemaking with respect to patient safety event information

Target Audience

Privacy Officers; Business Managers; Healthcare Providers and Quality Professionals; Quality Managers; Risk Managers; and Research Administrators.

Presenter

Patricia C. Shea, Esq. is a partner with the law firm of Kirkpatrick & Lockhart Preston Gates Ellis LLP where she advises corporations and non-profit organizations on a wide array of business and regulatory issues. Her primary focus is the representation of entities in the health care, insurance and consumer service industries.  In particular, Ms. Shea regularly counsels employers, health care providers, and health plans about their obligations under the federal Health Insurance Portability and Accountability Act (“HIPAA”) and the implementing regulations, as well as other state laws governing the use and disclosure of private health information.  She regularly advises health plans about ongoing federal and state regulatory mandates such as claims payment, provider participation agreements, reserve requirements, and board of director membership requirements and obligations, and privacy requirements.  She works with employer plans to evaluate regulatory obligations and risks associated with implementing employer-sponsored convenient care clinics.

Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.

Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number CBRN-11147-2008-WEB-482). Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-000-08-021-L04-P  has been assigned to this program. This program provides 1.5 contact hours of continuing education credit. A statement of credit will be e-mailed to participants within 2 weeks of the program. Each participant must submit a completed evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 9/24/08. Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form.  These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2008-WEB-481).