A Year in Review – Key Developments In Research Compliance and Regulation
James Riddle, MCSE, CIP, CPIA, CRQM Vice President, Institutional Services & Strategic Consulting ADVARRA
• Stay informed on the most recent compliance and regulatory developments related to research.
• Be prepared for upcoming changes in FDA research regulations.
• Take home a checklist of compliance action items for your organization.
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What COVID 19 and Other Changes Mean for Your Privacy Impact Analysis
Moderator:
Leeann Habte Partner Best & Krieger
Speakers:
Pegah K. Parsi Campus Privacy Officer UC San Diego
Shirley Komoto, CHC, CHPC Senior Manager BDO USA LLP
• Recent changes to data privacy laws - GDPR, CCPA, Part 2, COVID 19 waivers of enforcement discretion
• Case study of COVID privacy issues
• Structuring your privacy impact analysis to account for changes to laws, remote working environments, increased use of telehealth/ remote monitoring and more
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Post-acute and Hospital Perspectives Compliance Challenges
Moderator:
Jon Redden Chief Operating Officer U.S. Healthcare Partners Inc.
Speakers:
Lori Laubach Partner Reg. Compliance Practice Moss Adams, LLP
Tami Johnson-White Sr. Vice President and Chief Compliance Officer Kindred
• Hospital and sub-acute facility partnerships
• Definition of Continuum of care and what does this mean to the both health care systems (hospital and post-acute)
• Challenges in order to reduce readmissions or continual transfers of care
• Increased attention and challenges surrounding regulatory compliance – what is that 8th and potential 9th element
• How can compliance officers be proactive?
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Investigations – What Compliance Officers Need to Know
Christie Moon Senior Counsel, Special Investigations Unit Sutter Health
• Attorney Client and Other Investigative Privileges
• Investigation Planning & Strategy - Your Checklist
• Investigating in Collaboration with other Health Care Teams
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Handout
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CMS Update: COVID-19 and Beyond
Mary. G. Greene, MD, MPH, MBA Senior Advisor CMS Office of the Administrator
• Waivers and regulatory flexibilities granted during the COVID-19 Public Health Emergency
• Burden reduction through Patients over Paperwork and interoperability
• Areas of focus to safeguard program integrity
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Legal and Regulatory Update
Stephanie Johnson Partner King and Spalding
• Discuss recent legal and regulatory developments and how these developments may impact healthcare providers
• Discuss anticipated areas of enforcement and regulatory focus for 2020 and beyond
• Discuss proactive compliance strategies and practical tips
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