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HIPAA
Privacy
Rule
A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and wellbeing.
Health Information Privacy Rule (HIPAA):
What's it all about?
What's the mandate?
Providers, developers & health information networks must enable patients to
receive & control
their own EHR
1
All actors in the healthcare ecosystem must
share interoperable Electronic Health Information (EHI)
through APIs & FHIR
2
All actors must
comply with
Health Insurance Portability & Accountability Act (HIPAA)
3
What's the purpose?
Modernize clinical trials using real-world data & clinical outcome assessments to speed development of novel medical products,
including medical countermeasures
1
Expedite Treatments by accelerating novel therapeutics & medical devices, including Regenerative Medicine Advanced Therapy, Breakthrough Devices Program, Oncology Center of Excellence
2
Coordinate
Population Health
by directing FDA to create
one or more institutes to help coordinate activities in major disease areas between drug, biologics & device centers; improves the regulation
of combination products
3
Who does it impact?
PROVIDERS
PAYORS
REVENUE CYCLE MANAGEMENT (RCMs)
HEALTH INFORMATION NETWORKS (HINs)
HEALTH INFORMATION EXCHANGES (HIEs)
SYSTEM INTEGRATORS