Healthcare Regulation & Compliance Webinar
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Overview

Earlier this year, the U.S. Department of Health and Human Services (HHS) released its much-anticipated revisions to its HIPAA regulations and the Centers for Medicare and Medicaid Services (CMS) published its Final Rule on the physician payment transparency provisions of the well-publicized Patient Protection and Affordable Care Act (the ACA). These newly issued regulations will have major impacts on the pharmaceutical market research industry. This webinar will get you up to date on these new developments and help you develop a plan for compliance.
________________________________________________________________________________________


Russell Anderson

Attorney,
Lev & Berlin, P.C.

Duane Berlin

Principal,
Lev & Berlin, P.C.


Peter Milla
Consultant


Jessica Santos
Global Compliance
Director,
Kantar Health
________________________________________________________________________________________

HIPAA Amendments
The revised HIPAA regulations confirm that "business associates” are indeed subject to the same stringent requirements of the HIPAA Security and Privacy Rules as HIPAA-covered entities and will be subject to direct audit and enforcement activity by HHS.HHS also further extended the reach of HIPAA to "subcontractors” of business associates.
As a result, market research companies that receive patient information
from health care providers will need to:




Who Will Benefit:
  • Compliance Director
  • CEO
  • Privacy / Security Officer
  • Information Systems Manager
  • HIPAA Officer
  • Chief Information Officer
  • General Counsel/Attorney
  • Implement and maintain information security policies that comply with the HIPAA Security Rule
  • Enter into business associate agreements with the health care provider
  • Enter into separate business associate agreements as the "covered entity” with their vendors with which they share protected health information.

Of particular note: Business associates will need to perform a HIPAA security risk analysis and put in place HIPAA security policies; the more general security safeguards historically required through business associate contracts are no longer sufficient.

Final Sunshine Act Rules

In a hard-fought win for the market research industry, the Centers for Medicare and Medicaid Services preserved the Sunshine Act’s exemption for blinded market research. This webinar will address a number of common questions that have come up since the issuance of the Act’s Final Rule, including:

  • What constitutes "blinded” market research
  • Contractual approaches with clients to preserve physician respondent confidentiality
  • The current state of physician payments reporting on both the federal and state level in the US
__________________________________________________________________________________________

Russell Anderson, Attorney, Lev & Berlin, P.C.
Russ is an attorney with the firm of Lev & Berlin, P.C., and together with General Counsel Duane Berlin, is part of CASRO’s legal team. Russ is an expert in the laws and regulations governing the market research industry, including privacy, data security and technology law. Together with Duane, Russ routinely drafts and negotiates contracts and agreements for many leading market survey research firms. Russ also has an extensive practice in corporate and securities laws. He is a graduate of the College of William and Mary Law School and Wesleyan University.

Duane Berlin, Principal, Lev & Berlin, P.C.

Duane is a leading authority on legal issues affecting the survey research industry, having represented research companies for his entire 25-year career. Duane has served as legal counsel to CASRO for the past 12 years. In his work for CASRO he has submitted two legal briefs to the U.S. Supreme Court and has represented the industry and the association on many legal challenges relating principally to respondent confidentiality. Duane is a member of the International Association of Privacy Professionals and a member of the Board of Directors of The Roper Center for Public Opinion Research at the University of Connecticut.

Peter Milla, Consultant

Peter is a consultant specializing in information technology and market research with specific expertise in Internet, mobile and healthcare market research. He also is an expert in privacy, regulation, security and quality. Previously, Peter was CIO at Survey Sampling International and CIO at Harris Interactive. Peter has assumed leadership roles in several industry association workgroups and committees in the areas of technology, government affairs, ISO (quality standards) and Internet research. He is also the lead CASRO and ANSI representative to the ISO workgroups for standards relating to quality in market research (ISO 20252 and ISO 26362). Peter also serves as a Fellow of the Ponemon Institute.

Jessica Santos, Global Compliance Director, Kantar Health

Jessica is the Global Compliance Director in Kantar Health, the largest custom market research company focused on the life sciences industry. Jessica is primarily responsible for providing oversight and support across the 40+ Kantar Health (KH) global offices in the area of regulation, interaction with clients, suppliers and others within Kantar Health, Kantar and WPP. Jessica is responsible for maintaining, anticipating and coordinating all activities with regard to compliance laws/regulations, industry guidelines and client contracts, defining and driving the execution of the Kantar Health Quality Strategy – KH’s approach to measuring and improving our quality efforts. Jessica is an experienced statistician, analyst, methodologist and market research scientist. She gained her reputation through her publications and professional committee work in the industry. Jessica is a frequent speaker and contributor in major conferences. She has a PhD in Marketing, full membership in MRS and Chartered Marketer status.

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