Compliance Trainings, Online
2014-09-17
HIPAA, which stands for Health Insurance Portability & Accountability Act, does not just apply to health insurance. The rules apply to all companies with Personal Health Information (PHI) in electronic formats – doctors, health plans, pharma organizations, government programs, research organizations, testing organizations, pharmacies, clinics, IT services for regulated organizations, and more. In March of 2013, the HIPAA Omnibus Final Rule took effect, with major changes around Business Associate definitions, requirements for security breaches, and increased focus on privacy and greater fines for non-compliance. Anyone dealing with Patient Health Information (PHI) in the Pharma / Biotech / Medical Device and other Life-sciences companies, is subject to the HIPAA regulations as well as GxP Regulations. Sometimes the two regulations overlap, while other times something that would pass inspection by the FDA might not pass a HIPAA inspection and vice versa. Consequently, it is important to implement both sets of regulations. This webinar will explain HIPAA and the impact of HIPAA to the Life-sciences Industry, followed by explaining how to leverage the GxP work that a company already has, to create a cost effective approach to complying with both GxP and HIPAA requirements. Areas Covered in the Session : Overview of HIPAA and the 2013 Rule Structure History Recent Changes to HIPAA Penalties for Non-Compliance The culpability of Business Associates for Non-Compliance Enforcement History Title II – Administrative Simplification HIPAA Privacy HIPAA Security HIPAA EDI HIPAA Identifiers HIPAA at GxP Facilties Areas of Overlap Areas of Disparity Leveraging GxP Controls for HIPAA Compliance Who Will Benefit: Doctors Nurses Clinical Research Associates Clinical Auditors Clinical Operations managers VP of IT IT Managers IT Personnel Quality Control Quality Assurance Regulatory Affairs Document control managers Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Complaince Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : support@compliancetrainings.com
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