Understanding health IT regulations, standards, and software development best-practices is challenging. Correctly applying those regulations, standards, and best-practices is even more challenging. Our health IT experts have decades of experience successfully navigating the complex requirements of health IT, and we’re here to train the software and computer professionals on your team how to do it, too.
What We Do
Quandary Peak Research experts are available to provide customized training sessions (both onsite and remote) in areas such as:
- Understanding complex health IT standards and regulations.
- Proper drafting of technical documentation for regulatory submissions.
- Implementing best practices for software reviews.
- Successfully communicating with independent review organizations (IROs) and proactively addressing IRO requests.
- Achieving maximum progress and performance under a corporate integrity agreement (CIA).
- Streamlining the proposal submission, review cycle and approval process.
- Applying process-based standards like ISO 13485 and ISO 14971 to Electronic Health Record software.
What We Know
- Quality risk management compliance
- Gap analyses & independent audits
- Clinical software risk management standards
- Risk Evaluation and Mitigation Strategies (REMS) drug safety programs
- Patient safety (DCB-0129)
- Annual assessment and FDA reporting
- CEHRT/MIPS
- IRO requests
- Meaningful Use criteria and conformance
- ONC SAFER Guides
- Medical vocabularies and standards such as SNOMED, LOINC, HL7, FHIR, NCPDP
