Patient health information capture

Clarifications:

• There is no standard required for this certification criterion.
• This criterion replaces the § 170.314(a)(17) Advance directives and applies to various patient health information documents. [see also 80 FR 62661]
• We encourage health IT developers to develop innovative and efficient ways to meet this criterion and simultaneously support providers accepting health information from patient. [see also 80 FR 62662]
• Although the privacy and security requirements described above do not require that a privacy and security certification criterion must be explicitly tested with this functionality at § 170.315(e)(3), Health IT Module developers should perform their own security risk assessment to determine if additional security protections are necessary. For example, if a Health IT Module requires that a user first save a patient-supplied document to their end-user device before capturing the information, developers should consider adding end-user device encryption to protect this data. However, this functionality is not required to meet the privacy and security requirements for certification but is strongly recommended.

Technical outcome – A user can identify, record, and access information directly and electronically shared by a patient.

Clarification:

• The intent of this provision is to establish at least one means for accepting patient health information directly and electronically from patients in the most flexible manner possible. [see also 80 FR 62662]
• The criterion does not seek to define the types of health information that could be accepted as ONC believes this should be as broad as possible and could be documents or health information from devices or applications. The devices and applications could include home health or personal health monitoring devices, fitness and nutrition applications, or a variety of other devices and applications. In addition, patient health information could be accepted directly and electronically through a patient portal, an API, or even email. [see also 80 FR 62662]
• “Identify,” by example, means labeling health information documents as “advance directives” or “birth plans.” [see also 80 FR 62662]
• “Record,” means the ability to capture and store. [see also 80 FR 62610 and 77 FR 54168]
• “Access,” means the ability to examine and review. [see also 80 FR 62610 and 77 FR 54168]

Technical outcome – A user can reference and link to patient health information documents.

Clarification:

• “Reference” requires providing narrative information on where to locate a specific health information document. [see also 80 FR 62662]
• “Linking” requires a Health IT Module to demonstrate it could link, via the internet, to an external site/source storing a health information document(s). While an intranet link to a health information document might suffice for provider use, a Health IT Module will still need to demonstrate the ability to link to an external site via the internet or external storage source.
  • The criterion does not define how and to what the health IT links (e.g., Dropbox, another health IT developer’s patient health record, a state advance directive repository, etc.). However, linking to an integrated portal would not suffice.
  • The requirement of this provision does not go beyond the specified functionality such as demonstrating the log-in/authentication process in connection with linking, via the internet, to an external site/source. [see also 80 FR 62662]
  • This requirement is separate and distinct from the criterion's requirement that health IT be able to demonstrate that it can access information directly and electronically shared by a patient (paragraph (e)(3)(i)).