Increased adaptation of technology has been driving the growth and innovation in the healthcare industry of the US. With equal efforts from organizations as well as government bodies, the reason why technology has been driving healthcare is to make healthcare patient-centric and patient-personalized.
While MedTech and Digital Health innovators have been striving to create devices and healthcare solutions that provide continuous health monitoring and remote care applications, FDA, ONC, CMS, and other governing bodies have been working to make technology accessible for healthcare.
For instance, the 21st Century Cures Act, Trump Administration’s MyHealthEData initiative, and ONC’s efforts to make healthcare data interoperable are all instances of how the government is driving the use of MedTech and digital healthcare solutions in healthcare.
But, with increased facilitation also comes an increased need to validate your product, comply with stringent FDA regulations, and create truly interoperable solutions that can help amplify the reach of your medical devices and digital health solutions.
Data Interoperability – the need of the hour:
Talking about interoperability in healthcare, there has been a pressing need for EHR data interoperability under Trump Administration’s MyHealthEData initiative! Whether you are a payer, provider, or MedTech innovator, for increased adaptation of your technology, you will have to make your devices and ecosystems interoperable.
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
To create such an interoperable ecosystem and align your product with the 21st Cures Act, MedTech companies especially those wearable medical devices that wish to be a DaaS and care intelligence platform, they must establish data, cloud, and software fundamentals that help them become FDA certified and create truly scalable solutions.
But to ensure compliance and interoperability in healthcare, below are certain challenges that Medical Device companies have to address:
Compliance and Interoperability challenges faced by Medical Wearable Devices and MedTech companies:
Challenges of Interoperability in Healthcare:
- Inconsistent data and lack of standardized data structure
- Patient privacy and security while sharing data with open EHRs and interoperable systems
- Workflow alignment and lack of communication standards across EHRs
- Privacy and security enabling HIPPA compliant sharing poses significant challenge
- Patient ID Synchronization
Regulatory and Compliance challenges:
- 510(k) and PMA challenges
- Cybersecurity challenges
- Continuous monitoring challenges
- QA Automation for accelerated and error-free deployments
- Approvals in Breakthrough Devices program for advanced FDA support and recognition
- De novo classification request for innovative solutions
To overcome these challenges, MedTech must have one trusted MedTech digital enabler or compliance readiness partner that can help them create an effective digital ecosystem for their devices and data. Collaborating with an integration, compliance, and interoperability expert can provide the following benefits to MedTech and Medical Wearable Device innovators.
The expertise of MedTech Healthcare digital partner that Medical Devices and MedTech companies and leverage:
Validation and Verification Services-
End-to-end partnership from defining and designing the data architecture to testing the solution data generation for optimum output, DaaS-oriented interoperability, and FDA compliance. Ensure whether you data is clean, usable, and accurate with our expert data engineers with in-depth expertise in MedTech.
Experts can also provide effective testing around anticipated signal management and verify redundancy for software and hardware. During the SDLC, an expert MedTech V&V consulting will conduct traceability analysis, Interface Analysis, Criticality Analysis as well as Hazard and Risk Analysis.
Data Transformation Enabler-
For HL7 FHIR compliance and to make your device data truly accessible and interoperable, MedTech partner creates effective data structures, data management, and data transfer practices for devices, platforms, and the cloud.
Device and Cloud Integrations-
Help medical device and MedTech companies become a DaaS by creating HL7 FHIR-compliant data sets and segregating them in a manner that can be shared with Open EHRs and EMR systems as well as other data consumers such as payers, providers, patients, pharmaceuticals, CROs and clinical trial organizations.
With the majority of players accessing AWS cloud infrastructure, experts can help you with Interoperability architecture that is built with the majority OOTB components of AWS and based on your use case and data type, they can also create data classifier, parser and AI Deep Learning based distributor that can be then linked to Medical Comprehend for standardization and distribution with user-specific APIs.
Software Test Automation-
For security readiness, error-free deployment and to create a secure and interoperable data ecosystem, MedTech engineering partner can provide end-to-end Device to Cloud QA automation capabilities with the right mix of automation models, tools, and frameworks.
From identifying the right combination of manual and automation testing practices to selecting the right automation tools, automation engagement approach to complete programming implementation and post-implementation support, MedTech partner would provide personalized and custom-tailored test automation capabilities.
Compliance and Regulatory Consulting-
An experienced and domain expert MedTech compliance partner can ensure GMP, GCP, HL7, HIPAA, and HITRUST compliance for all your devices, digital health, and SaMD solutions.
From creating HIPAA and HITRUST checklists to determining the cybersecurity readiness to threat modelling to device and software cybersecurity risk assessment reports, a partner would be a part of the compliance process right from the start and help you with documentation and testing reports that could expedite the process and validate FDA requirements.
API Development-
Share only relevant and user-specific data with your partners by developing robust APIs for seamless data exchange and interoperability.
A good foundation builds a secure healthcare future:
Not just for FDA compliance, but to ensure that MedTech companies create truly patient-centric solutions, they must create optimum scalability and flexibility while maintaining patient data integrity. Looking for the right MedTech engineering partner? Let’s discuss!
