2103313006_Sakshi Desai_MPH104T.pptx

1. THE HEALTH INSURANCE PORTABILITY
AND ACCOUNTABILITYACT
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Seminar/Assignment-I
(MSA106P)
For the Subject
Regulatory Affaires(MPH104T)
Submitted to
Drs. Kiran & Pallavi Patel Global
University (KPGU)
Guided by:
Dr. Ashok Mahajan
Professor
M Pharm. PhD.
KSP
Presented by:
Sakshi Desai
M.Pharm Sem-I
Pharmaceutics Branch
En.No.2103313006
Krishna School of Pharmacy & Research (KSP)
Krishna Edu Campus ,Vadodara Mumbai NH#8,
Varnama, Vadodara
Sakshi Desai

2. HIPAA
The Health Insurance
Portability And
Accountability Act
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3. The Goal Of HIPAA
The primary goal of HIPAA is :
 To make a law easier for people to keep
health insurance.
 Protect the confidentiality and security of
health care information.
 Help healthcare industry to control
administration cost.
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4. What does HIPAA consist of ?
i. Standardized Electronic Data Interchange
transactions and codes for all covered
entities.
ii. Standards for security of data system.
iii. Privacy protections for individual health
information.
iv. Standard national identifiers for health care.
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5. HIPAA components
(Electronic Data
interchange)
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6. About HIPAA
Portability
 This sections allows
individuals to carry their
health insurance from one
job to another, so that they
do not have a failure in
coverage.
 It also restrict health plans
requiring pre-existing
condition of an individuals
who switch from one health
plan to another.
Administrative Simplification
 This section is
establishment of a set of
standard for receiving,
transmitting and
maintaining the health care
information.
 Ensuring the privacy and
security of individuals
identifiable information.
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7. HIPAA Rules
Privacy Rule : Apply to Protected Health
Information (PHI) in all forms oral, written and
electronic. Penalties for improper disclosure and
misuse.
Security Rule : Monitor access to PHI and lays out
specific requirements concerning contracts
between CE and their business associates.
Policies and procedures to ensure the health
organization’s compliance with HIPAA.
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10. HIPAA IN
CLINICAL TRIALS
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12. • Researcher must understand the permissible
routes of access of PHI for research activity.
• Researcher must implement necessary safeguards
to protect the PHI.
The Privacy Rule permits a covered entity to use
disclose PHI for research :
I. When an individual authorization has been
obtained from a research participant.
II. When a waiver of authorization has been
obtained.
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13. For Clinical Studies
• To disclose PHI in research, the researcher
must obtain:
o An authorization from the individual patient
o A wavier of authorization for the study.
• An authorization is the HIPAA equivalent of
consent to use and disclose data.
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14. Patient Authorization
1) The authorization must be written in plain
language.
2) Can be combined with the consent if
research involves treatment.
3) Research including existing records would
require a separate authorization.
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15. Wavier Authorization
I. Disclosure involves no more then minimal
risk to the individual.
II. The waiver will not adversely affect the
privacy rights of individual.
III. Research could not be conducted without
the waiver.
IV. Research could not be conducted without
access to protected health information.
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16. Research Subject Recruitment
 Recruitment for research is subject to the
general authorization requirement unless the
researcher has a direct treatment relationship
with the patient.
 Researchers could use the Waiver of
authorization mechanism to access PHI for
recruiting prospective research subject.
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17. Revocation Of Authorization
Research subjects can revoke their authorization
in writing at any time. This is subject to an
exception know as the Reliance Exception.
A subject wishing to revoke the authorization
must be given a form for Revocation of
authorization.
If the subject does not sign and return the form,
then the researcher may continue to use the PHI
and treat the authorization as valid.
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