An understanding of HIPAA upcoming changes for 2016

Professionals at various levels of the healthcare industry need to have a grasp of the HIPAA Security/Privacy Rule and the way it relates to their practice or business. A two-day, in person, live seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer this very important understanding.

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Brian Tuttle, a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), and Certified Business Resilience Auditor (CBRA) , who brings over 15 years’ experience in Health IT and Compliance Consulting, will be the speaker at this seminar. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900727SEMINAR to enroll for this highly educative session.

A host of areas relating to HIPAA and changes for 2016

Among the areas that Brian will take up are the changes under the Omnibus Rule and any other applicable updates for HIPAA for 2016. There are an enormous amount of issues and risks that Covered Entities and Business Associates these days. He will also dwell upon other aspects of HIPAA, such as:

  • The history of HIPAA
  • Privacy vs. security,
  • Business Associates,
  • Changes for 2016
  • Audit process
  • Paper-based PHI
  • HIPAA and suing
  • Texting
  • Email
  • Encryption
  • Medical messaging
  • Voice data, and lots more.

Myths vs. realities of HIPAA

Essentially, Brian will explain myths versus reality as it relates to this very enigmatic law, and this clarification will be based on over 1000 risk assessments he has performed during the many years of experience he gained in dealing directly with the Office of Civil Rights HIPAA auditors during his career.

Understanding the risk factors for being sued for wrongful disclosures

He will also speak of real life audits conducted by the Federal government and help participants understand what their highest risks are for being fined. He will discuss the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using State laws to sue for wrongful disclosures.

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He will offer an explanation of the multiple litigated cases that he has been a part of involving HIPAA situations. He will also thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information and demonstrate how to limit those risks by simply taking proactive steps and utilizing best practices.

Brian will cover the following areas at this seminar:

  • History of HIPAA
  • HITECH
  • HIPAA Omnibus Rule
  • How to perform a HIPAA Security Risk Assessment
  • What is involved in a Federal audit and how is it conducted
  • Risk factors for a federal audit
  • EHR and HIPAA
  • Business Continuity/Disaster Recovery Planning
  • Business Associates and HIPAA
  • In depth discussions on IT down to the nuts and bolts
  • BYOD
  • Risk factors that can cause an audit (low hanging fruit)
  • New rules which grant states ability to sue citing HIPAA on behalf of a patient
  • New funding measures.

 

Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

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Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will provide just this and fulfill this requirement.

Dr. Steven Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director at this two-day session. To enroll for this valuable session, please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900701SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An interactive session

Dr. Kuwahara will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance in view of the recent FDA guidance document on Process Validation.

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This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated.