Step 4: Is the Software Function Intended to Serve as Electronic Patient Records?
Certain software functions that are intended to serve as electronic patient records are not devices within the meaning of section 201(h) of the FD&C Act. Specifically, software functions that are intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart are not devices if the criteria outlined in section 520(o)(1)(C)(i) – (iii) of the FD&C Act are met.
Step 4 will help determine if your software function that is intended to serve as electronic patient records is a device.
4.A: Is the software function intended to serve as electronic patient records, or to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart?
Continue to Question 4.B.
Your product may be a device. Go to Step 5.
WHY: All of the criteria outlined in section 520(o)(1)(C) of the FD&C Act must be met for a software function to be excluded from the device definition by this section. Question 4.A reflects the criteria in section 520(o)(1)(C) of the FD&C Act. Therefore, answering "No" to Question 4.A suggests the software function is not excluded from the device definition by this section.
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
4.B: Is the software function intended for interpretation or analysis of patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition?
Your product may be a device. Because you answered "Yes" to Question 4.B, the next relevant question is in Step 6.
WHY: All of the criteria outlined in section 520(o)(1)(C) of the FD&C Act must be met for a software function to be excluded from the device definition by this section. Question 4.B reflects the criteria in section 520(o)(1)(C)(iii) of the FD&C Act. Therefore, answering "Yes" to Question 4.B suggests the software function is not excluded from the device definition by this section.
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
Continue to Question 4.C.
4.C: Are the software function records created, stored, transferred, or reviewed by health care professionals or by individuals working under their supervision?
Continue to Question 4.D.
LIKELY NOT A DEVICE
WHY: All of the criteria outlined in section 520(o)(1)(C) of the FD&C Act must be met for a software function to be excluded from the device definition by this section. Question 4.C reflects the criteria in section 520(o)(1)(C)(i) of the FD&C Act. Therefore, answering "No" to Question 4.C suggests the software function is not excluded from the device definition by this section. However, software functions that enable patients, individuals, or non-health care professionals to create, store, or transfer health records are considered personal health records (PHRs). These software functions in PHR systems that are not intended for use in the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition are not devices under section 201(h) of the FD&C Act. For example, the Policy for Device Software Functions and Mobile Medical Applications includes in Appendix A (Examples of Software Functions that are NOT medical devices) "Software functions that provide patients with simple tools to organize and record their health information." Considering your answers to the previous questions, answering "No" to Question 4.C suggests that the software function may not meet the device definition.
If you are unsure, go to Step 5 to learn about other device criteria and considerations that may apply to your software function.
LEARN: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (see Section IV.C. for examples of software functions intended for non-health care professionals); Policy for Device Software Functions and Mobile Medical Applications (see Appendix A. for examples of software functions that are NOT medical devices).
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 and review the next software function.
4.D: Are the software function records certified under a program of voluntary certification kept or recognized by the Office of the National Coordinator for Health Information Technology (ONC)?
LIKELY NOT A DEVICE
The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program provides assurance to purchasers and other users that a system meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services (HHS).
The ONC Health IT Certification Program is a voluntary certification program established by the ONC to provide for the certification of health IT. Requirements for certification are established by standards, implementation specifications, and certification criteria adopted by the Secretary at the HHS. The Certification Program supports the availability of certified health IT for its encouraged and required use under other federal, state, and private programs. The Certification Program is run as a third-party product conformity assessment scheme for health information technology (health IT) based on the principles of the International Standards Organization (ISO) and International Electrotechnical Commission (IEC) framework.
WHY: Under section 520(o)(1)(C) of the FD&C Act, the term device does not include certain software functions that are intended to serve as electronic patient records. Specifically, software functions that are intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart are not devices, if all the following three criteria outlined in section 520(o)(1)(C)(i) – (iii) are met:
- Such records were created, stored, transferred, or reviewed by health care professionals or by individuals working under supervision of such professionals;
- Such records are part of information technology certified under a program of voluntary certification kept or recognized by the Office of the National Coordinator for Health Information Technology (ONC) under section 3001(c)(5) of the Public Health Service Act ("ONC Health IT Certification Program"); and
- Such software functions are not intended for interpretation or analysis of patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.
Considering your answers to the previous questions, answering "Yes" to Question 4.D suggests that the software function may not meet the device definition.
If you are unsure, go to Step 5 to learn about other device criteria and considerations that may apply to your software function.
LEARN: ONC Health IT Certification Program; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
LIKELY FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION
The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program provides assurance to purchasers and other users that a system meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services (HHS).
The ONC Health IT Certification Program is a voluntary certification program established by the ONC to provide for the certification of health IT. Requirements for certification are established by standards, implementation specifications, and certification criteria adopted by the Secretary at the HHS. The Certification Program supports the availability of certified health IT for its encouraged and required use under other federal, state, and private programs. The Certification Program is run as a third-party product conformity assessment scheme for health information technology (health IT) based on the principles of the International Standards Organization (ISO) and International Electrotechnical Commission (IEC) framework.
WHY: Based on our current understanding of the risks of these devices, the FDA does not intend at this time to enforce compliance to the requirements of the FD&C Act for software functions that are not certified under the ONC Health IT Certification Program if they meet the other criteria in section 520(o)(1)(C)(i) and (iii) of the FD&C Act. Considering your answers to the previous questions, answering "No" to Question 4.D suggests the software function may fall within FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time).
If you are unsure, go to Step 5 to learn about other device criteria and considerations that may apply to your software function.
LEARN: ONC Health IT Certification Program; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
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