Compliance

No. While accredited CME/CE providers represent a core focus of our work, Twelve:01 partners with organizations and stakeholders across the healthcare continuing education ecosystem. 

• Non-Accredited Education Organizations: We provide accreditation readiness assessments and strategic guidance for organizations considering initial accreditation.  We also provide compliance training and corporate structure reviews.  
• Accreditation Boards & Regulatory Bodies: We actively engage with accreditation boards by participating in education events, working groups, and public comment opportunities, helping advance the continuing education profession while staying at the forefront of evolving accreditation requirements.
• Professional Membership Organizations: Our consultants are active members of organizations that support healthcare continuing education professionals. Through committee service, national and regional presentations, and education programming, we contribute to these organizations and the ongoing advancement of the profession.
• IME Divisions within Industry: We provide compliance training, workshops, and strategic advisory services for IME teams within pharmaceutical, biotechnology, and medical device companies, helping them understand and navigate the accreditation environment that shapes independent continuing education.
• Learners & Patients: We believe effective continuing education begins with understanding the needs of learners and the patients they serve. We help organizations incorporate learner and patient perspectives into education planning, prepare patient representatives who serve on planning committees, and assist in identifying opportunities to align accredited continuing education with broader patient safety and quality improvement initiatives.

Our work is ultimately guided by the broad purpose of strengthening healthcare continuing education to better support clinicians, improve education quality, and contribute to safer, higher-quality patient care.

Common accreditation compliance findings include incomplete documentation of planning decisions, insufficient or incorrect identification and mitigation of relevant financial relationships, inconsistent learner disclosures, incomplete performance-in-practice files, and inadequate documentation demonstrating how educational activities address identified professional practice gaps. Many of these issues can be prevented through standardized workflows, regular internal audits, and staff training. Read more about the common mistakes accredited CME/CE providers make and how to avoid them.

Probation provides an opportunity for an accredited provider to demonstrate corrective action and strengthen compliance processes. While it is a serious accreditation outcome, it does not mean an organization will automatically lose its accreditation. Organizations that respond proactively, by addressing deficiencies, implementing sustainable improvements, and preparing thoroughly for follow-up review, can often restore compliance.

Organizations should maintain documentation that demonstrates compliance throughout the educational planning, implementation, and evaluation process for each CME/CE activity. This typically includes gap analyses and needs assessments, planning committee documentation, disclosure and mitigation records, educational objectives, agendas, faculty communications, commercial support documentation (when applicable), evaluation summaries, outcomes data, and associated learner records of activity completion and credit claimed.

There is no universal accreditation requirement specifying audit frequency, but routine internal auditing is widely considered a best practice. Conducting audits quarterly, semiannually, or annually helps organizations identify compliance gaps early, promote consistency across activity planning, and reduce compliance risk during accreditation reviews. The appropriate frequency should reflect your organization’s size, activity volume, and internal resources.

Artificial intelligence (AI) can be used in accredited continuing education, but it should be applied thoughtfully and with appropriate governance. AI can enhance efficiency in areas such as content development, administrative workflows, data analysis, and communications. Accredited providers remain responsible, however, for ensuring educational independence, protecting confidential and protected information, maintaining transparency, and ensuring human oversight. Organizations should establish AI governance policies that define approved uses, identify potential risks, and ensure alignment with accreditation standards and organizational values. Read more about building AI readiness in continuing medical education.