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Job Description: The Sr. Analyst II, Regulatory Affairs role will focus on interpreting and implementing regulatory technical standards and specifications critical to healthcare interoperability and compliance. The successful candidate will also possess deep expertise in regulatory-related codes and value sets used in Electronic Health Records, collaborating with developers, product managers, and compliance teams to ensure our solutions meet federal, state and industry requirements. The ideal candidate will have a deep understanding of ONC Certification requirements, health IT standards and specifications, regulatory frameworks, and emerging trends within the healthcare industry.
- Analyze and ensure compliance with health information exchange standards such as USCDI, HL7, FHIR, CCDA, and IHE profiles.
- Collaborate with Product and Engineering teams to implement and validate standards like SNOMED CT, LOINC, ICD-10, HCPCS, RxNorm, UDI, UCUM, CDS Hooks, SMART on FHIR, and NCPDP SCRIPT.
- Monitor and support the adoption of emerging frameworks like TEFCA for nationwide interoperability.
- Analyze, interpret, and apply regulatory technical standards needed to achieve and maintain ONC Certification.
- Ensure organization's products and solutions are compliant with standards and specifications as a requirement of other Federal and State regulatory programs, including HIPAA, 42 CFR Part 2, and other data segmentation and privacy regulations.
- Maintain deep knowledge and subject matter expertise of the HL7 Da Vinci Project standards/implementation guides to support conformance with electronic Prior Authorization API requirements.
- Ensure organization's products and solutions align with the technical standards required of quality reporting programs, digital quality measures (dQM), electronic clinical quality measures (eCQMs) and QRDA standards for quality reporting. Support compliance with CMS, registry reporting, public health agency reporting, and other regulatory agency reporting requirements.
- Serve as a liaison between NextGen Healthcare and external standards organizations (e.g., HL7, NCPDP, etc.).
- Provide subject matter expertise for internal teams on relevant health IT standards, regulatory requirements, and emerging standards and specification trends in the industry.
- Serve as a representative of NextGen's Regulatory and Clinical affairs teams to help various internal stakeholders and development teams understand health IT standards and regulation insofar as it may affect our business, our software, and/or our clients.
- Serve as a representative of NextGen Healthcare and actively participate in the EHRA's Standards & Interoperability (S&I) Workgroup.
- Support internal resources responsible for the creation of user documentation, training materials, and compliance checklists to facilitate adherence to standards.
- Perform other duties that support the overall objective of the position.
Education Required:
- Bachelor's degree in Health Informatics or related discipline.
- Master's degree in Health Informatics or related discipline preferred.
- Or, any combination of education and experience which would provide the required qualifications for the position.
Experience Required:
- 6+ years of experience working in the Health Informatics industry.
- 4+ years of experience working with healthcare-related regulatory programs.
- Demonstrated expertise working with Health IT technical and interoperability standards.
- Demonstrated understanding of the forces shaping healthcare delivery including but not limited to the Health Information Technology (HITECH) and Medicare Access and Chip Reauthorization Act (MACRA) legislation and related programs and regulations.
- Demonstrated understanding and experience with the ONC Health IT Certification Program is highly desirable.
- Experience with data exchange standards and technologies is highly desirable.
License/Certification Required:
- NextGen Certified Professional (NCP) Certification within 6 months of employment.
Knowledge, Skills & Abilities:
- Knowledge of:Technical knowledge and proficiency in Health IT standards and specifications. Strong familiarity with healthcare codification standards and value set systems. Fundamental understanding of U.S. healthcare regulations pertaining to health IT vendors and end-users. Understanding of contemporary research methodologies and data analysis.
- Skill in:Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Effective collaboration skills. Meticulous and detail-oriented with attention to follow-through and issue resolution.
- Ability to:Convey complex technical concepts to less-technical stakeholders. Lead meetings, teams, and projects with cross-functional departments.
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
NextGen Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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NextGen Healthcare
May 20, 2025