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The 21st
Century
Cures Act
The 21st Century Cures Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations & advances to patients who need them faster and more efficiently.
The 21st Century Cures Act:
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