Developer Terms of Use
Developer Guidelines
Required ONC Certification Criteria
To ensure minimum standards for safe and effective healthcare software, you and your Apps must meet the below list of ONC certification criteria.
For each App you submit, you must provide one of the following for Epic, Community Members, and users to review:
- Public documentation that your App has been certified to the below specified ONC criteria.
- Public documentation of equivalent functionality in lieu of formal certification.
- Public documentation describing why specific criteria aren’t applicable for your App.
Epic or Community Members may review documentation supplied by you at any time to ensure you meet these criteria. If documentation you supply is missing or inaccurate, Epic or Community Members may take action on your App, including notifying users of your App’s non-compliance, or suspending your App until the issue can be resolved.
45 CFR 170.315 (b)(6) (Data Export): "A user can configure the technology to create export summaries using the Continuity of Care Document document template."↩
45 CFR 170.315 (d)(1) (Authentication, Access Control, Authorization): "Verify against a unique identifier(s) (e.g., username or number) that a user seeking access to electronic health information is the one claimed; and [...] establish the type of access to electronic health information a user is permitted based on the unique identifier(s) provided"↩
45 CFR 170.315 (d)(2) (Auditable Events and Tamper-resistance): "The health IT records actions pertaining to electronic health information [...] when health IT is in use; changes to user privileges when health IT is in use; and records the date and time [each action occurs]. [...] The health IT records the audit log status [...] when the audit log status is changed and records the date and time each action occurs. [...] The health IT records the information [...] when the encryption status of locally stored electronic health information on end-user devices is changed and records the date and time each action occurs.↩
45 CFR 170.315 (d)(3) (Audit Report(s)): "Enable a user to create an audit report for a specific time period and to sort entries in the audit log according to each of the data."↩
45 CFR 170.315 (d)(5) (Automatic Access Time-out): "Automatically stop user access to health information after a predetermined period of inactivity. [...] Require user authentication in order to resume or regain the access that was stopped."↩
45 CFR 170.315 (d)(7) (End-user Device Encryption): "Technology that is designed to locally store electronic health information on end-user devices must encrypt the electronic health information stored on such devices after use of the technology on those devices stops [or] technology is designed to prevent electronic health information from being locally stored on end-user devices after use of the technology on those devices stops."↩
45 CFR 170.315 (d)(8) (Integrity): "Verify [...] upon receipt of electronically exchanged health information that such information has not been altered."↩
45 CFR 170.315 (d)(9) (Trusted Connection): "Health IT needs to provide a level of trusted connection using either 1) encrypted and integrity message protection or 2) a trusted connection for transport."↩
45 CFR 170.315 (d)(11) (Accounting of Disclosures): "Record disclosures made for treatment, payment, and health care operations."↩
45 CFR 170.315 (g)(3) (Safety-enhanced Design): "User-centered design processes must be applied to each capability technology."↩
45 CFR 170.315 (g)(4) (Quality Management System): "For each capability that a technology includes and for which that capability's certification is sought, the use of a Quality Management System (QMS) in the development, testing, implementation, and maintenance of that capability must be identified."↩
45 CFR 170.315 (g)(5) (Accessibility-centered Design): "The use of a health IT accessibility-centered design standard or law in the development, testing, implementation and maintenance of that capability must be identified."↩
45 CFR 170.315 (g)(7) (Application Access - Patient Selection): " The technology must be able to receive a request with sufficient information to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data."↩
45 CFR 170.315 (g)(8) (Application Access - Data Category Request): "Respond to requests for patient data (based on an ID or other token) for each of the individual data categories specified in the Common Clinical Data Set and return the full set of data for that data category (according to the specified standards, where applicable) in a computable format."↩
45 CFR 170.315 (g)(9) (Application Access - All Data Request): "Respond to requests for patient data (based on an ID or other token) for all of the data categories specified in the Common Clinical Data Set at one time and return such data (according to the specified standards, where applicable) in a summary record formatted [...] following the CCD document template."↩
45 CFR 170.523 (k)(1) (Pricing Transparency): "Any additional types of costs that an EP, EH, or CAH would pay to implement the Complete EHR's or EHR Module's capabilities in order to attempt to meet meaningful use objectives and measures."↩
45 CFR 170.523 (n) (Complaint Process): "Submit a list of complaints received to the National Coordinator on a quarterly basis each calendar year that includes the number of complaints received, the nature/substance of each complaint, and the type of complainant for each complaint."↩
Additional Proposed Suspension Criteria
In the future, ONC certification intends to also determine whether HIT modules are:
- Contributing to a patient’s health information being unsecured and unprotected in violation of applicable law;
- increasing medical errors;
- decreasing the detection, prevention, and management of chronic diseases;
- worsening the identification and response to public health threats and emergencies; leading to inappropriate care;
- worsening health care outcomes;
- or undermining a more effective marketplace, greater competition, greater systems analysis, and increased consumer choice.
You will want to be mindful of these goals as you develop your App.