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
All actors in the healthcare ecosystem must
share interoperable Electronic Health Information (EHI)
through APIs & FHIR
All actors must
Health Insurance Portability & Accountability Act (HIPAA)
What's the purpose?
Modernize clinical trials using real-world data & clinical outcome assessments to speed development of novel medical products,
including medical countermeasures
Expedite Treatments by accelerating novel therapeutics & medical devices, including Regenerative Medicine Advanced Therapy, Breakthrough Devices Program, Oncology Center of Excellence
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
Who does it impact?
REVENUE CYCLE MANAGEMENT (RCMs)
HEALTH INFORMATION NETWORKS (HINs)
HEALTH INFORMATION EXCHANGES (HIEs)