Hippa new requirement to clinical study processes

HIPPA- New Requirement to clinical study process

1. HIPPA-NEW REQUIREMENT TO CLINICAL STUDY PROCESSES BY S.KAVYA M.PHARMACY (PHARMACEUTICS )

2. HIPPA HIPPA is the Health Insurance Portability and Accountability Act of 1996. It is a Privacy rule provides Federal Privacy Protection for individually identifiable health information called Protected Health Information.

3. Reason For Arrival In 2000 many Patients were Diagnosed with Depression They all received free SAMPLES OF ANTIDEPRESSANT MEDICATION. After Investigation the truth has been disclosed that the doctors shared patient information with the industries. Patient wonder why ???

4. Protected Health Information GINA

5. Contents of HIPPA Title 1 – Protects Health Insurance Coverage for workers and their families when they change or lose their job. Title 2- Prevents Health care Frauds and Abuse. Title 3- Guidelines for Pre-Tax medical spending. Title 4- Guidelines for Group Health Insurance Plans. Title 5 - Governs company owned Life Insurance policies.

6. Who must Comply with HIPPA physicians Dentals Laboratories Intermediate Consultancies Pilot Fish Health care centre

7. Who must not Comply with HIPPA The medical Records in Schools are protected by Family Educational Rights and Privacy Act State police service act

8. HIPPA – IN CLINICAL TRIALS

9. SCENARIO

10. What is HIPPA HIPPA RESEARCH COVERED ENTITY PROTECTED HEALTH INFORMATION HIPPA

11. Preparatory Work Covered Entity - Physician He should accept the Proposal developed by the Researcher for obtaining PHI PHI is needed for writing Protocol for Clinical studies. Potential Health Subjects.

12. Actual Procedure An Individual’s written authorization is required for Protected Health Information. Authorization Waivers can be Granted by IRB’S Accounting and Reporting of disclosures are required.

13. Accounting Disclosures

14. GENERAL DISCLOSURE MULTIPLEDISCLOSURES It includes disclosure of Date , recipient , address It includes disclosure of Date , Recipient , recipient address and Purpose of Disclosure , Frequency of Disclosure. Accounting is not needed for Disclosures of meagre information Disclosure of PHI helps to withdrawal a particular patient.

15. EXAMPLES

16. Pre –Research Review of Medical Records

17. Authorization for Research Must be for a Specific Research study It should be combined with Informed consent Maintenance of a Research repository or the Database

18. Recruitment

19. The Exclusion Criteria- policy

20. Insurance in HIPPA

21. Funding Organizations

22. CONTRADICTION TO CLINICAL TRIALS

23. References Marilyn Windschiegl HIPPA Basics For Clinical Research 2007 12-25 Karen Blackwell New HIPPA Privacy Regulations Governing Research