ONC Data Interoperability Mandates in the US
To increase digital data interoperability between healthcare systems and data consumers such as CROs, Clinical Trials, Payors, Providers and Pharmaceutical companies, Office of the National Coordinator for Health Information Technology (ONC) has created following mandates:
Recent Government Announcements around Data Interoperability:
- ONC has identified HL7 FHIR Release 4.0.1 as the foundational standard to support data exchange
- Qualified Health Plan providers are required to implement and maintain a secure, standards-based API
- Hospitals to send electronic patient data to other practitioners for appropriate follow-up care
- For Medical Devices catering to Patients, CROs, Payers or Providers, they must ensure their data and cloud platform has EHR interoperability
AIMDek’s Data Interoperability Cloud Architecture for IoMT & Medical Devices
With IoMT and Medical Device industry facing challenges due to the pricing concerns of consumers:
- 39% of Medical Device companies are incorporating data as an added value to justify the pricing
- 31% are offering data distribution channels as a service.
Sooner or later, to become a medical grade DaaS company or to create a Cloud Intelligence platform that shares or stream patient healthcare data to all their B2B data consumers such as CROs, Clinical Trial companies, Payors, Providers and Pharmaceutical companies, they would have to adhere to the HL7 FHIR interoperability mandates!
Introducing Medical Grade DaaS Accelerator
Architecture for Cloud
Supported
Cloud System
The Architecture
Benefits
- Ability to become DaaS and cloud-intelligence platform
- 6 Ready to use APIs built as per the HL7 FHIR guidelines for Data Consumers
- IoMT companies can comply with 21st Century Cures Act as well as Data Interoperability mandates
AIMDek Integration Ecosystem
Premarket Medical Device Cybersecurity
Readiness Services
Ensure your medical devices’ readiness for the US market and get FDA 510(k) cybersecurity approval with AIMDek’s premarket Medical Device cybersecurity readiness services.
We deploy a team of subject matter experts that help you understand the process and provide detailed cybersecurity and software security testing services to ensure 510(k) readiness with minimal efforts from your end.
As a part of our comprehensive cybersecurity assessment services, we provide our clients with:
- Threat modeling
- Device and software Cybersecurity risk assessment report
- Medical Device software security testing and assessment reports
- Complete vulnerability assessment for third-party software (if required)
- A detailed plan for continuing cybersecurity support
LOOKING TO CONVERT FROM CONSUMER TO MEDICAL GRADE DEVICE ?
Wish to employ our AIMDek DaaS Accelerator?