Health Level Seven, Inc. ®
Unlocking the Power of Health Information
An ANSI accredited standards developer
September 2, 2009
Office of Congressman Patrick J. Kennedy
407 Cannon House Office Building
U.S. House of Representatives
Washington , D.C. 20515
RE: Comments on the Kennd_043 Bill – The Personal Health Information Act of 2009
Dear Honorable Patrick Kennedy,
The leadership of the Health Level Seven (HL7) Personal Health Records Work Group (PHR WG) and the HL7 Board of Directors appreciate the opportunity to provide input on your working draft of the proposed new bill, “The Personal Health Information Act of 2009.” We have provided a summary of our key concerns on the content and a detailed list of our suggestions to improve the proposed bill.
HL7 is a not-for-profit, ANSI-accredited standards development organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7’s more than 2,300 members represent approximately 500 corporate members, which include more than 90 percent of the information systems vendors serving healthcare. The PHR WG—a subgroup sponsored by the Electronic Health Records Work Group (EHR WG)—created the PHR System Functional Model (PHR-S FM), which describes the functions that may comprise various types of PHR systems. The PHR-S FM was approved as a Draft Standard for Trial Use (DSTU) in July, 2008. Both the PHR WG and the HL7 Board offer the following comments from this standards-based perspective, along with the industry experience of our members who have worked with and supported PHR systems.
Though we believe that the current bill does a good job on describing how the use of Personal Health Records can enhance the meaningful use of electronic health record systems, below are key items in the bill that we hope will receive appropriate consideration as part of improving the quality and content of the proposed bill:
1) Use of two alternative standards, CCD and CCR (page 4, line 21).
The language of the bill specifies that either the CCR or the CCD could be used. It is important to point out that only the CCD was the standard recently selected by the Health Information Technology Standards Committee (HITSC), and prior to that, by the Health Information Technology Standards Panel (HITSP) and recognized by the Secretary of Health and Human Services. Therefore, at the very least the language of the bill should be consistent with the specifications from these authorities. However, we recommend that the bill refer to neither the CCR nor the CCD specifically, as that would be too limiting. Instead we strongly recommend the bill include all Clinical Document Architecture (CDA)-based documents—of which the CCD is one—as well as all clinical and administrative messages necessary to exchange health information between PHR and EHR systems.
Specifying both messages and CDA-based documents helps broaden the scope of standards to support the PHR. For example, while the CCD may be appropriate in some use cases to provide input into a PHR, other CDA-based documents may be better for other purposes (a targeted summary for patients upon their discharge, for instance). Moreover, the full suite of standards to support PHRs should not be limited to documents, as a message may be more appropriate than a document in some instances (e.g., a PHR initiating an appointment request).
2) Consistent use of terms.
a) The term of art in the industry is “Personal Health Record System” or “PHR System”. The bill’s use of “interactive personal health record” or “personally controlled personal health record” (e.g. page 2, line 7 and page 6, line 3 respectively) could be a source of confusion.
b) “Consumer-controllability” (page 5, line 5) is not a common term used by the Health IT industry. It would be clearer and more accurate to use comparable wording in the bill, such as “access to the record is controlled by the patient or their guardian.”
c) “Full transferability” (page 4, line 24) is not a common term used by the Health IT industry. It would be less confusing and more accurate to use the term “portability.”
3) “Consent management” (page 4, line 19) is generally considered to be part of Privacy and Security. A variety of existing standards have already been recognized as part of Privacy and Security. It would be more accurate and a better reflection of available and widely used standards to simply state that “personal health record systems should adhere to privacy and security standards.”
After a careful review of the draft of the proposed bill, we developed the following suggestions, mostly minor, to improve the accuracy and clarity of the text:
- Pages 1, 2, 4, 5, 6 & 7 – Throughout the document, replace “interactive personal health record”, “personally controlled personal health records” and “electronic and interactive personal health records” with “Personal Health Record systems” which is the industry recognized term and the name of the functional model standard recognized by HL7 and the International Organization for Standardization (ISO).
- Page 2, line 21: Sec.2 (a) (1) (9) (B) (i ) - Delete the word “protocol.” Protocol is a word linked by most to operating rules or standard operating procedures. In the area of PHR, much of the sponsorship and technical support of PHRs is in the private sector. It would be too prescriptive for federal laws or regulations to provide such detailed guidance on operating procedures that will be unique to trading partner and technology implications.
- Page 3, line 4: Sec.2 (a) (1) (9) (B) (ii) – Consistent with the above we suggest deleting the term “protocols.”
- Page 3, line 10: Sec.2 (a) (1) (9) (B) (iii ) – Consider replacing “community health centers” with “community health programs” and adding the concept of “wellness” to align with page 6, line 12, which appropriately reflects an expansion beyond health centers (to hospitals, clinics, private practice and long-term-care), and to better distinguish between where a PHR is used and how it is used. We suggest the following wording: “…in the form of PHR Systems to improve the effective and efficient exchange and management of information between the patient (or their guardian) and the various community health, prevention, wellness, chronic disease management, and public health monitoring and improvement programs…”
- Page 3, line 20 Sec.2 (a) (1) (9) (C ) – Replace the phrase surrounding the term “format” with “… complies with appropriate data content standards ...”, which would be a more accurate phrase that reflects data elements, data types, codes, terms, units, templates, etc. that would be included in an electronic communication.
- Page 3, line 21: Sec.2 (a) (1) (9) (C) - “Extract” is a term usually associated with programmer access to data files. “… retrieve data from …” is a more accurate match for the existing “input data into” on line 22. This change should avoid any implication of programmer support and focus on the consumer’s ability to perform some form of data input and access.
- Page 4, line 19 Sec.2 (a) (1) (9) (C) (vi) – “Consent management” is generally considered to be part of Privacy and Security. A variety of existing standards have already been recognized as part of Privacy and Security. It would be more accurate and a better reflection of available and widely used standards to simply refer to “privacy and security standards.”
- Page 4, line 24: Sec.2 (a) (1) (9) (C) (viii) - “Full transferability” would be a new term. It would be less confusing and more accurate to use the common industry term “portability.”
- Page 5, line 5 Sec.2 (a) (1) (9) (C) (x) - “Consumer-controllability” would be a new term, and unclear to the industry. It would be clearer and more accurate to use existing wording in the bill, such as “Access to the record is controlled by the patient or their guardian.”
- Page 5, line 11: Sec.2 (a) (1) (9) (C) (x) - “ payers. ”
- Page 6, line 1: Sec.2 (a) (2) (F) (ii) – “Adequacy” is a very subjective term in the area of technology standards. A report on the “status” of standards would likely better serve the industry – i.e., to understand the level of availability and the status of each standard’s use.
- Page 6, line 12: Sec.2 (a) (2) (F) (iv) – Consider aligning this text with page 3, line 11 for consistency and recognition of wellness programs. “… “…in the form of PHR Systems to improve the effective and efficient exchange and management of information between the patient (or their guardian) and the various community health, prevention, wellness, chronic disease management, and public health monitoring and improvement programs…”
- Page 6, line 14: Sec.2 (a) (2) (F) (v) – Consider adding an additional reporting item to document and track future impact of the success of the bill on increasing the use of PHR Systems “(v) the results of a cost/benefit study on the implementation costs, information exchange efficiencies/effectiveness, and impact on health outcomes traceable to the use of PHR systems, that will be conducted at a reasonable amount of time after data from each of the above report items is available (PHR deployments, status of interoperable standards, improvements to patient/provider communication, enhance community health)”
The leadership of the PHR Work Group and the HL7 Board recommend that the above suggestions, edits and revisions be incorporated into your proposed PHR bill. We applaud your efforts to enhance the ARRA/HITECH definition of Meaningful Use which will facilitate the effective expansion of PHR systems and improve the quality of care and care coordination. We wish you success in your efforts to gain support for the passage of this bill.
If you wish us to provide further information or if there are any questions regarding this letter and its recommendations, please contact Karen Van Hentenryck, HL7 Associate Executive Director, at (734) 677-7777, or email@example.com . She will get you in touch with the appropriate WG co-chairs and expert volunteers who can respond to your request. If we can further assist you, we welcome the opportunity to provide our support.
John D. Ritter W. Edward Hammond, PhD
PHR WG Co-Chair Board Chair
Donald T. Mon, PhD Charles Jaffe, MD, PhD
PHR WG Co-Chair Chief Executive Officer