Washington, D.C.
The National Committee on Vital and Health Statistics was convened on November 15-16, 2001 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
1. The Committee unanimously voted to approve the report on the National Health Information Infrastructure, along with a revision and final approval process, described below.
2. The Committee unanimously passed a motion approving a revised letter to the Secretary containing recommendations on the research provisions of the privacy regulation. It also approved a final revision and approval process, described below.
This meeting was chaired by Dr. Simon Cohn. Dr. Lumpkin participated in part of the meeting by telephone. Dr. Cohn welcomed new NCVHS member Dr. John Danaher, a Connecticut-based internist and information specialist.
Data Standards: Karen Trudel, CMS
Privacy Regulation: Susan McAndrew and Kathleen Fyffe, OCR
Mr. Scanlon announced two additional personnel changes: Dr. Braithwaite is leaving HHS and his NCVHS staffing role, and Kathleen Fyffe has resigned from NCVHS to join the HHS Office of Civil Rights staff. (The Committee held a dinner on November 15 to honor them.) He then updated the Committee on several ongoing Departmental activities: the commissioned National Academy of Sciences study of the adequacy of race/ethnicity data; the establishment of an electronic portal for better access to HHS data, statistics, and program evaluation studies as well as some policy research; and development of guidelines to ensure the quality of disseminated HHS information. He briefed the group on the status of recent NCVHS recommendations on functional status, PMRI standards, HIPAA implementation, modifying the privacy rules, and race/ethnicity data, and reported that efforts are underway to schedule a meeting between Dr. Lumpkin and the Secretary or Deputy Secretary.
letter-spacing: -.15pt' Ms. Trudel reported that as a result of restructuring by Administrator Scully to bring a higher-level focus to HIPAA within CMS, Jared Adair is now the senior executive responsible for all HIPAA activities in the agency, reporting directly to the Administrator’s office. CMS has just produced a 30-minute video on HIPAA for providers. Ms. Trudel briefed the group on the status of HIPAA regulations. There are a number of notices of proposed rulemaking, as well as final rules, under review. Final regulations on employer identification and security standards and proposed rules on claims attachments and plan identifier are under review and will be published as they are approved internally; the final rule for the provider identifier is still under discussion.
Ms. McAndrew reported that the Department has not made a final decision about the privacy regulation and will fully comment on the NCVHS recommendations when it publishes the final rule. The OCR is working on guidance materials that will be posted on the Web to assist with compliance. On the timing of publication, although the hope was to have a final rule by April 2002, that is now unlikely, but the process is still on a fast track. She predicted a January or February publication of the proposed rule. Ms. McAndrew publicly welcomed Ms. Fyffe to her new role in OCR in charge of public education, technical assistance and outreach.
Ms. Fyffe said this area of OCR is now fully staffed. They are developing materials and will decide where and how to direct outreach once Congress has approved a budget. She welcomed input and feedback from the Committee on these questions.
DEPARTMENTAL INFORMATION SYSTEMS
Brian Burns, Deputy Chief Information Officer, HHS
Mr. Burns briefed the Committee on HHS initiatives in its information infrastructure development and applications. Its objectives are to mitigate risks, reduce costs, and improve efficiency. The approaches to these ends include making security and privacy the top priority, consolidating wherever possible in collaboration with the Data Council, and procuring enterprise-wide licensing. A major goal is to integrate the Department’s 2,000 Web sites. HIPAA will be a major factor driving infrastructure development. The IT staff are collaborating with the Data Council, ASPE, CMS and OCR on the various dimensions of HIPAA. In the security area, the Healthcare PKI Working Group, under the auspices of the federal PKE bridge, is trying to figure out how to get all the various agencies to communicate and build a commonly usable solution. Of the 23 activities being supported by the Quicksilver Team of the federal E-government Committee, HHS will be heavily involved in three: e-common health informatics, e-vital statistics, and e-grants. Mr. Burns stressed the importance of privacy protections, public key infrastructure (PKI), and collaboration with standards groups in this endeavor.
In the discussion session, NCVHS members expressed appreciation for the briefing and urged that Mr. Burns’ office be attentive to user interests, to the sensitivities around PKI, and to concerns about the consequences of integration. A detailed discussion of security issues among members led to a decision to schedule a panel on PKI and digital signature for the February NCVHS meeting. Mr. Burns and the Committee agreed to remain in contact in the future.
Dr. Lumpkin briefly summarized the key themes of the August retreat of the Executive Subcommittee. At that meeting, it reaffirmed the Committee’s commitment to population health as well as to the standards and privacy priorities brought to the fore by HIPAA; it considered a closer relationship to AHRQ in regard to the National Quality Report; and it agreed to have periodic briefings on international activities and to redouble efforts to build bridges among areas and disciplines.
Dr. Lumpkin then presented the draft final NHII report, “Information for Health: Strategies for Building the National Health Information Infrastructure,” thanking the staff, the contract writer, and NHII Workgroup members for their contributions. He pointed to the timeliness and even urgency of the report and recommendations in the wake of September 11. Besides being critical to improving the public’s health, health information is a matter of national security. The key message of the report, the need for federal leadership, was heard consistently from those who testified at NCVHS hearings on the NHII held around the country.
Committee members generally endorsed the report and recommendations, offering a number of suggested edits that were acceptable to the NHII Workgroup. The group discussed ways to ensure that the report is given adequate attention by the Department, including asking for an annual update. They agreed to strengthen the statements about the potential efficiency and effectiveness benefits for the health care system that could result from the NHII, while noting that more research is needed on this matter.
Given the general support for the report and recommendations and the nature of the suggested changes, the Committee agreed to the following procedure, proposed by Dr. Lumpkin: The Committee will vote on the report which, if approved, will be referred to the NHII Workgroup for revisions based on this discussion. The revised version will be sent to the Committee for review, with a defined comment period. When the comments are received, the report will be revised further as needed; the Executive Subcommittee will then determine whether the comments or final changes are significant enough to require a second full Committee vote. If not, it will make the final decision on publication of the report. The goal is to deliver it to the Department in early 2002.
The Committee then unanimously voted to approve the report, under the terms described above, along with the revision process proposed by Dr. Lumpkin.
REVIEW OF PRIVACY RECOMMENDATIONS
Mr. Rothstein led the Committee in a review of a letter to Secretary Thompson, containing recommendations on the research provisions of the proposed final HHS privacy rule. The recommendations are based on August hearings by the Subcommittee on Privacy and Confidentiality, addressing the rule’s provisions regarding consent, disclosure, research, and marketing. The letter follows on an October 1, 2001 letter from NCVHS on consent requirements and minimum necessary provisions; a forthcoming one will address marketing, possibly after further hearings. He summarized the issues related to research and the Subcommittee’s views on each one, and then invited comments on the draft letter.
In their comments, Committee members focused in particular on the need for education and outreach in the field to allay the fears of researchers that important research would be restrained or prevented because of the privacy rules, in some cases through a misunderstanding of the rules.
Based on this discussion, the Subcommittee on Privacy and Confidentiality met in the afternoon and revised the draft letter, which it presented for discussion and action on day two of this meeting. Following another detailed discussion of the issues related to education and outreach, the Committee passed a motion approving the revised letter, conditional on the further revisions recommended by the Committee. The newly revised letter will be distributed to the full Committee by e-mail for comments, which will be referred to the Executive Subcommittee for final action. The final letter will be sent to the Secretary as well as posted on the NCVHS Web site
PRESENTATION TO GAIL HORLICK
Ms. Greenberg announced that Gail Horlick is stepping down from her position as lead staff to the Subcommittee on Privacy and Confidentiality, although she will remain as a staffer representing CDC. Ms. Greenberg commended Ms. Horlick for her hard and successful work on such tasks as setting up the Subcommittee’s hearings and drafting its policy recommendation letters, and presented her with an award recognizing her contributions.
DEPARTMENT OF DEFENSE’S E-HEALTH INITIATIVE: Capt. Brian Kelly, DoD
Capt. Kelly is the Project Director for the DoD Military Health System’s pilot project on E-health, which is working toward a DoD-wide infrastructure for the use of the Internet for all DoD patients and beneficiaries, providers, and managers. The secure Internet portal is named TRICARE Online. The goals of the initiative are to improve access to care, quality of care, population health, and force readiness protection, and to manage the business effectively.
The Internet offers a way to build continuity, reduce administrative overhead, and improve communication. The expectation is that by moving to self-service for such things as referral, authorizations, enrollments, appointing, and claims, DoD can save a half-billion dollars a year of its current 20 billion dollar health systems budget. The application most popular with users is the ability to make appointments through the primary care manager online. Internet-based appointments and claims save DoD about $7 per transaction.
DoD beneficiaries say they want efficient access to care, high quality health information, and control of their health information. The platform is scalable so it can be rolled out quickly. Several features will be added in the next year, such as the ability for providers to access various forms of information remotely. Beneficiaries have indicated an interest in patient-provider e-mail communication, but DoD will go into this “very, very slowly” because of the security issues involved. The system was recently alpha-tested. There are 3,000 users, including about 800 physicians and 2,400 patients, and 85 more hospitals will join in the next few months. The plan is to include all 600 DoD hospitals by the end of 2002.
The main steps in implementation involve training, management, and marketing, and technical support. Capt. Kelly described the organizational infrastructure to mount this effort, which involves 15 regions around the world. He showed the Committee slides of screens in the portal (which can be accessed at www.tricareonline.com). He noted that the approach to registration is especially relevant to the national health information infrastructure discussion. The DoD’s general approach to security is to balance what is on the portal with the level of security it can offer, something that will grow over time.
In the discussion period, Committee members had questions about integration with legacy systems, the relevance of the GCPR, the approach to evaluation, and plans for making the portal available to providers for HIPAA transactions. Both Dr. Kelly and Dr. Cohn noted the overlaps and common themes between this initiative and the Committee’s NHII project.
UPDATE ON NCHS STATISTICAL ACTIVITIES: Dr. Ed Sondik, Director
Dr. Sondik described the Center’s vital statistics activities, emphasizing the extensive “re-engineering” that has taken place in recent years. He then discussed the surveys managed by NCHS, which also are undergoing considerable restructuring and integration. There is an overall effort to get data out as quickly as possible. A new communication system and statistical design make it possible to get the data out much more rapidly than before. After touching on the Center’s international activities, he noted that the greatest challenge facing the Center is the balance between confidentiality and data access, especially in surveys such as NHANES that produce voluminous data on an individual. One approach to preserving confidentiality is through data centers that provide a protected research environment. NCHS is a partner with NCVHS and the Data Council in developing a vision for 21st century health statistics. Summarizing the major themes and issues facing NCHS, Dr. Sondik mentioned confidentiality, access, release, and the need for more research, along with the need for more resources.
In the discussion session, Committee members expressed interest in talking with Dr. Sondik next time about how the Committee can be helpful to the Center.
CONCLUDING DISCUSSIONS
Following brief reports on future workplans of the work groups and subcommittees and a review of agenda items for the next meeting, Dr. Cohn adjourned the meeting.
DAY ONE
WELCOME AND CALL TO ORDER
Dr. Simon Cohn, the Acting Chair, called the meeting to order. He welcomed new NCVHS member Dr. John Danaher, a Connecticut-based internist with a special interest in information systems. He is currently starting up an E-learning company in the compliance area. After Dr. Cohn reviewed the agenda, all present introduced themselves.
In addition to the appointment of Dr. Danaher to the Committee, there have been two other recent personnel changes: Dr. Bill Braithwaite has left HHS, and thus his role in staffing NCVHS, to work in the private sector, and Kathleen Fyffe has resigned as an NCVHS member to take a position in the HHS Office of Civil Rights. (Both were honored in a special NCVHS dinner that evening.)
HHS has gone forward with the study of the adequacy of race/ethnicity data in the health systems of federal agencies and the private sector, as directed by the Minority Health Research and Disparities Act. For the 24-month study, the National Academy of Sciences will appoint a panel of 10-12 members and hold a workshop to look at policies and practices. There is considerable confusion in the private sector about the legality of collecting race/ethnicity information and its proper uses, and the Department hopes the Academy study will shed light on these concerns in its resulting report to Congress, expected in about 20 months. NCVHS has been invited to suggest members for the panel. Mr. Scanlon said he would supply the Committee with the scope of work and Congressional language for this project, which concerns quality, safety, and the potential for discrimination, among other issues.
The Department is pulling together an electronic gateway or portal for better access to its health and human services data, statistics, and program evaluation studies as well as some policy research. Virtually all HHS Web sites are being pulled together along with related ones done under the Department’s auspices, including state and HHS contractor Web sites. The portal will include links to NCVHS, the Data Council and other data policy Web sites. The prototype is being tested in ASPE, and will be beta tested in HHS in December. The site will include special archives on privacy and other important topics.
Another current HHS project involves establishing guidelines to ensure the quality of information being disseminated, pursuant to an OMB directive that stems from the Shelby Amendment related to release of data collected under research grants. This will result by October 2002 in a single set of criteria and procedures for information quality control throughout the Department. The same process is taking place in other federal agencies.
Turning to the status of various NCVHS recommendations, Mr. Scanlon reported that the Data Council met recently with Dr. Iezzoni regarding the Committee’s functional status recommendations. The agencies have been asked to look at the recommendations and determine next steps. Regarding an NCVHS letter to CMS about race/ethnicity data in Medicare Managed Care, the Data Council sent a similar letter to CMS. Regarding recommendations on modifying the privacy regulation, these are being considered by the office for Civil Rights. The Deputy Secretary has responded in writing to the Committee’s June 2001 recommendations about HIPAA regulation implementation. There are efforts to set up a meeting between Dr. Lumpkin and the Secretary or Deputy Secretary as soon as possible, an occasion that might be used to present the NHII report. Finally, the Committee’s recommendations on patient medical record info have been discussed in the Data Council and circulated among the agencies. There is a lot of receptivity to the process laid out by NCVHS regarding PMRI standard recommendations. Dr. Cohn noted that communications from Deputy Secretary Allen are posted on the NCVHS Web site.
Data Standards: Karen Trudel, CMS
Ms. Trudel reported that as a result of restructuring by Administrator Scully to bring a higher-level focus to HIPAA within the agency, Jared Adair is now the senior executive responsible for all HIPAA activities in CMS, reporting directly to the Administrator’s office. Ms. Trudel is part of that organization, which will engage in liaison and outreach for all CMS HIPAA undertakings. CMS has just produced a 30-minute video on HIPAA for providers. It will first be broadcast via satellite on November 29. It is intended to produce general awareness and show viewers the activities of someone who is well along in compliance, and how they got started.
The Department has prepared NPRMs on the changes recommended by the DSMOs and endorsed by NCVHS. They will probably be published in December, with a 30-day comment period, aimed at keeping them in synch with the broader standards process. Final regulations on employer identification and security standards and proposed rules on claims attachments and plan identifier are under review and will be published as they are approved internally; the final rule for the provider identifier is still under discussion. An HHS working group is working on the enforcement regulations as well as on where in the Department these activities should take place. Ms. Trudel concluded with the observation that it was evident at a recent SNIP conference that industry is “stepping up to the plate” with regard to HIPAA implementation. The aforementioned video will be shown at regional SNIPs.
Dr. Cohn expressed appreciation for the Department’s efforts to expeditiously publish the remaining rules.
Privacy Regulation: Susan McAndrew and Kathleen Fyffe, OCR
Ms. McAndrew thanked the Committee for its public hearings on the privacy regulations and the resulting suggestions on modifications. The Department has not made final decisions about the regulation and will fully comment on the NCVHS recommendations when it publishes the final rule. The OCR is also working on guidance materials that will be posted on the Web to assist with compliance. Ms. McAndrew publicly welcomed Ms. Fyffe to her new role in OCR in charge of public education, technical assistance and outreach.
Ms. Fyffe said this area of OCR is now fully staffed; Linda Sanchez, Kelly Hilman, and Elke Chavez will work with her. They are developing materials and will decide where and how to direct outreach once Congress has approved a budget. She welcomed input and feedback from the Committee on these questions. Outreach will be conducted through the 10 HHS regions and with various State and regional trade associations and professional societies. Materials will be developed based on frequently asked questions and will include compliance checklists and summaries of the rules, among other things.
Asked about a timeline, Ms. McAndrew said the September 11 events had slowed the process; originally the hope was to have a final rule by April 2002, but that is now unlikely, although the process is still on a fast track. She predicted a January or February publication of the proposed rule.
Mr. Scanlon commented on the budget process, noting that September 11 had changed the process and priorities for both the 2002 and 2003 budgets. HHS has been very involved in bioterrorism efforts, requiring a lot of resources.
DEPARTMENTAL INFORMATION SYSTEMS
Brian Burns, Deputy Chief Information Officer, HHS
Mr. Burns briefed the Committee on HHS initiatives in infrastructure development and applications. He said one of the major challenges relates to building appropriate and adequate security. The drivers for these initiatives include the Clinger-Cohen Act, the Paperwork Reduction Act, security requirements, and HIPAA regulations. HHS needs to mitigate its risks, reduce its costs, and improve its efficiency. The approaches to these ends include making security and privacy the top priority, consolidating wherever possible in collaboration with the Data Council, and procuring enterprise-wide licensing. The intention is to design HHS Web sites as “a planned community instead of the urban sprawl we have today.” Mr. Burns noted the Department’s many outstanding Web sites, which include healthfinder and CancerNet but total some 2,000, with 400 Webmasters and 8 million WebPages. Secretary Thompson wants “one HHS,” so the emphasis is on integration.
The Department supports the enterprise architecture put out by the Federal CIO Council, though it thinks in terms of a four-level model rather than the Council’s five. Through E-government it seeks better continuity of systems, portals, and technologies. Mr. Burns and colleagues have developed a five-year plan with network redesign as the first step. To streamline things, they will use available models such as NEDSS and the usability concepts and resources developed by the National Cancer Institute (usability.gov). New financial management and human resource systems also will be put in place.
HIPAA will be a major factor driving infrastructure development. The HHS IT staff are collaborating with the Data Council, ASPE, CMS and OCR on the various dimensions of HIPAA. In the security area, the Healthcare PKI working group, under the auspices of the federal PKE bridge, is trying to figure out how to get all the various agencies to communicate and build a commonly usable solution. It is considering the Postal Service as one possible place to do registration, though not as the only possible mechanism. The Health Passport being piloted by the Western Governors Association is a good concept. Mr. Burns noted that the current impossibility of having a national health ID adds to the challenges; a likely solution is to go through the states. His office hopes to get some pilots going to demonstrate the capability of sharing medical information within the next year or two.
The E-government Committee, under the auspices of OMB and the Federal CIO Council, put together a “quicksilver team” that surveyed federal e-government activities and chose 23 initiatives to fund and promote as high priority. HHS will be heavily involved in three of these STYLE=';mso-ascii-mso-hansi-font-family: "Bookman Old Style";letter-spacing:-.15pt;mso-char-type:symbol;mso-symbol-font-family: Symbol'mso-char-type:symbol;mso-symbol-" e-common health informatics, e-vital statistics, and e-grants. Mr. Burns noted that the Department must be attentive to language and culture differences as it designs its screens, and also that privacy standards and PKI (public key infrastructure) will be critical. The goal is to get the federal bridge up and running to permit communication within the government, and then to hope that industry will agree with the same standards. HHS is working with other standards groups. Other initiatives are Web-based federal credentialing capability, which will be necessary for PKI, and the transmission of health records, telemedicine, knowledge management, and distance learning.
Discussion
Dr. Danaher remarked on the ambitiousness and scope of the endeavor. Based on his own experience, he urged that the Department ground these efforts in a knowledge of its customers and what they want and need. He observed that the Department is so internally complex that the CIO could get caught up in internal integration challenges and lose sight of who the customers are and what they want. Mr. Burns agreed, and reiterated that they are starting with testing, using NCI’s usability.gov resources. Dr. Danaher added that user profiles could be helpful in order to architect the data and customize to individuals’ needs, and Mr. Burns noted the privacy issues inherent in that approach.
Dr. Shortliffe called attention to the sensitivities around PKI and the
need to find a
“politically sensitive and acceptable approach.” He praised the
Department’s efforts to develop a coordinated federal approach and
infrastructure to support a variety of health applications; however, he also
noted that there are sensitivities and concerns about the potential loss of
independence and control as well as a possible suppression of creativity and
specialization. Mr. Burns assured the Committee that his focus is on “the
container, not the content,” and there is no intention to dictate content;
any integration or standardization in this area is the responsibility of the
Data Council, not IT people. Dr. Shortliffe noted that simply the creation of
an “organizational look” or watermark can affect content.
Mr. Blair applauded the Department’s commitment to working with standards communities in these efforts. He raised some questions about certification that generated a lengthy technical discussion and ultimately prompted the Committee to plan a subsequent session on PKI, digital signature, and related issues. Dr. Lumpkin said federal, state, and private partners should present at this session. Dr. Cohn thanked Mr. Burns for his far-reaching presentation and said the Committee would be interested in further discussions of shared concerns. Mr. Burns invited Committee members to attend the open meetings of the Healthcare PKI workgroup.
REPORT FROM EXECUTIVE SUBCOMMITTEE RETREAT: Dr. Lumpkin
Dr. Lumpkin reported that at its August retreat, a key issue discussed by the Executive Subcommittee was the tension that has existed since the passage of HIPAA involving the relative time and resources spent on population health data issues versus standards, security, and privacy. He said the Subcommittee concluded that any neglect of population health in recent years was a result of limited resources and personnel in the face of HIPAA requirements, not any lack of commitment to improving information for population health, and it reaffirmed the importance of both arenas of activity.
The Subcommittee also discussed the need to build bridges among areas and disciplines, and Dr. Lumpkin invited future input from Committee members on how to do that, for example, through hearings at full Committee meetings on cross-cutting issues. The Subcommittee also noted that the traditional NCVHS involvement in international issues had waned, and members agreed to have a periodic “international scan” to stay in touch with this important dimension. It also discussed ways to enhance the Committee’s relationship with AHRQ and the Quality Forum in relation to the National Quality Report, and ways to make the most of full-committee meeting time. FInally, it agreed to publish a general two-year report covering 2000 through 2002. Dr. Cohn noted that a separate annual report on HIPAA implementation is mandated by Congress. This report is the responsibility of the Subcommittee on Standards and Security, which this year hopes to collaborate with the Subcommittee on Privacy and Confidentiality. It hopes to present at least a preliminary draft in February.
REVIEW OF NHII REPORT: Dr. Lumpkin
Dr. Lumpkin then presented the draft final NHII report, “Information for Health: Strategies for Building the National Health Information Infrastructure,” which is the product of several years of work by the Committee. He thanked the staff, Dr. Deering, Ms. Bauer, Dr. Steindel, and Ms. Williamson, Ms. Kanaan, and NHII Workgroup members for their respective contributions. Noting that he is absent from the meeting because he is working on a bioterror response plan for the State of Illinois, he pointed to the timeliness and even urgency of the report and its recommendations in the wake of September 11. Besides being critical to improving the public’s health, health information is a matter of national security. The key message of the report, the need for federal leadership, was heard consistently from those who testified at NCVHS hearings on the NHII held around the country. The report lays out three stages for implementing the recommendations, starting with the creation of an adequately funded lead office within HHS. It stresses the need to accelerate the standards process and to provide incentives to stakeholders, whose participation is critical to implementation.
Discussion
At Dr. Lumpkin’s request, Committee members commented on the report. Dr. Cohn expressed general support for the recommendations but suggested reconsideration of the recommendation that the proposed HHS office have lead responsibility for privacy in the Department. Several others supported his suggestion, to which Dr. Lumpkin and other Workgroup members and staff were receptive. Dr. Deering explained that the general principle is that the proposed office would help bring together and coordinate responsibilities distributed across the Department.
Dr. Newacheck asked what steps were planned to ensure that the report gets the attention it deserves, a priority endorsed by other members. Dr. Lumpkin said the Committee should monitor the Department’s response; he and other Workgroup members stressed that there is already a great deal of interest in and anticipation for the report. Ms. Greenberg suggested asking HHS for an annual report on implementation, as is done in the functional status report. Dr. Friedman stressed that especially given the breadth of the recommendations in this report as well as that on 21st century health statistics, NCVHS should build monitoring of implementation into the workplans of the two Workgroups. Mr. Scanlon suggested further thought on the role of the market in implementation.
Dr. McDonald proposed revisions to the report’s language on the use of technology and on standards organizations, and he agreed to supply specific language. Other small edits were offered by other members. The group discussed whether the recommendations should be directed only at the federal government or more broadly; the general view was that even though federal action is the major focus and thrust of the report and a chief concern of stakeholders, the potential exists to influence the field beyond HHS. Furthermore, the need for collaboration among diverse stakeholders is a key message of the report. Ms. Greenberg and Mr. Scanlon both noted that NCVHS reports have a tradition of being embraced and having an impact outside the Department.
The discussion turned to the possible need for further support-building in the private sector and industry, and the related point of ways to strengthen the business case for the recommendations. On the first point, workgroup members explained that non-federal organizations were extensively consulted as the NHII report recommendations were developed over the past three years, particularly through hearings around the country, and there is considerable anticipation for the recommendations. The preliminary and interim reports were very well received. Dr. Sondik articulated the second point and stimulated a discussion of how to discuss the “bottom line” in the absence of sufficient research on this aspect. Members agreed to cite what research is available and to highlight the Committee’s firm belief, one probably widely shared in the field, that better information systems will lead to better patient care and safety, improved efficiency and effectiveness of healthcare, and ultimately improved population health. The idea is to enable the reader to explore cost-benefit issues without trying to make a definitive case. Dr. Deering invited members to suggest useful references for this purpose.
Dr. Shortliffe, who served on the bodies that produced the National Research Council’s Networking Health and the report of the President’s Information Technology Advisory Committee, both of which addressed these same subjects over the last decade, commented on “the growing consensus about the federal role” he has seen emerging in that time. The “more prescriptive” NCVHS recommendations represent a natural progression of the three reports.
Given the Committee’s general support for the report and recommendations, and the nature of the suggested changes, the Committee agreed to the following procedure, proposed by Dr. Lumpkin: The Committee will vote on the report and, if approved, it will be referred to the NHII Workgroup for revisions based on this discussion. The revised version will be sent to the Committee for review, with a defined comment period. When the comments are received, the report will be revised further as needed; the Executive Subcommittee will then determine whether the comments or final changes are significant enough to require a second full Committee vote. If not, it will make the final decision on publication of the report. The goal is to deliver it to the Department in early 2002.
Asked about a dissemination strategy, Dr. Deering said professional organizations are already requesting the report. In addition to being posted on the NCVHS and NHII Web sites, it will be sent to the NCVHS mailing list. The Committee then unanimously voted to approve the report, under the terms just described, along with the revision process proposed by Dr. Lumpkin.
BRIEFING FROM THE EXECUTIVE SECRETARY
Ms. Greenberg pointed out that members had been supplied with a pocket version of the International Classification of Functioning, Disability and Health (ICF), which was discussed in detail in the Committee’s recent report on functional status. Full versions are available to members on request. She also reported that the North American Collaborating Center hosted the 2001 annual meeting of the Family of International Classifications. She offered to report on that meeting at the February NCVHS meeting.
REVIEW OF PRIVACY RECOMMENDATIONS
Mr. Rothstein led the Committee in a review of a letter to Secretary Thompson, containing the Committee’s recommendations on the research provisions of the proposed final HHS privacy rule. The recommendations are based on August hearings by the Subcommittee on Privacy and Confidentiality, which addressed the rule’s provisions regarding consent, disclosure, research, and marketing. The letter follows on an October 1, 2001 letter from NCVHS on consent requirements and minimum necessary provisions; a forthcoming one will address marketing, possibly after further hearings. He reviewed the six issues related to research and the Subcommittee’s views on each one. First, some witnesses wanted research to be brought in with treatment, payment, and healthcare operations, all covered by a general consent (the Subcommittee does not favor this approach). Second, there are concerns about the burden of the de-identification requirements. The third issue concerns recruitment of research subjects; the fourth, post-marketing surveillance; and the fifth, the burdens of the requirements for accounting for disclosure. Finally, the Subcommittee supports the HHS Office of Civil Rights in its education efforts. Mr. Rothstein invited the Committee’s comments and discussion (which are presented in full in the meeting transcript, posted on the NCVHS Web site) on the draft letter.
The discussion highlighted some of the professional education issues and needs and demonstrated the importance of the education effort. For instance, Dr. McDonald urged that a table be developed that shows “what qualifies what,” to help clarify the rules. He observed that because of misunderstandings, researchers may be prevented from doing things that are not actually forbidden by the rules. Dr. Mays noted the need to clarify which decisions are left to IRBs, perhaps with reference to internal community standards requirements, and which are preempted by the HHS rules. Dr. Shortliffe asked about the impact on longitudinal studies such as Framingham. Dr. Mays noted that given today’s technology, both retrospective and prospective research must be done differently now than it was decades ago, when the limits of information technology provided their own kind of protection of subjects. Dr. McDonald expressed concern about restraint of potentially beneficial research, either external or self-imposed, because of overconcern about the privacy rules. Members expressed interest in having a briefing from a representative of the HHS Office for Human Research Protection.
Mr. Rothstein said that based on this discussion, the Subcommittee on Privacy and Confidentiality would revise the draft letter to the Secretary and present it for action the following day.
PRESENTATION TO MS. HORLICK
Ms. Greenberg announced that Gail Horlick is stepping down from her position as lead staff to the Subcommittee on Privacy and Confidentiality, although she will remain as a staffer representing CDC. Ms. Greenberg commended Ms. Horlick for her hard and successful work on such tasks as setting up the Subcommittee’s hearings and drafting its policy recommendation letters. She presented her with an award recognizing her contributions to the NCVHS privacy recommendations.
DEPARTMENT OF DEFENSE’S E-HEALTH INITIATIVE: Capt. Brian Kelly, DoD
Capt. Kelly is the Project Director for the DoD Military Health System’s pilot project on E-health, which is working toward a DoD-wide infrastructure for the use of the Internet for all DoD patients and beneficiaries, providers, and managers. The secure Internet portal is named TRICARE Online. The goals of the initiative are to improve access to care, quality of care, population health, and force readiness protection, and to manage the business effectively.
When the project began in the summer of 2000, an inventory of the 300 existing health-related projects on the Internet found that most were local, “champion-driven,” and without regard for life cycle cost management. Only a handful addressed security issues. The DoD knew it would have to comply with HIPAA as well as the Americans with Disabilities Act and serve a highly mobile population (8.4 million beneficiaries in 50 states and 80 countries). The Internet offers a way to build continuity, reduce administrative overhead, and improve communication. The expectation is that by moving to self-service for such things as referral, authorizations, enrollments, appointing and claims, DoD can save a half-billion dollars a year of its current 20 billion dollar health systems budget. (Internet-based appointments and claims save about $7 per transaction.)
Regarding population health initiatives, Capt. Kelly said that despite the educational and age diversity of DoD beneficiaries, they all want the same things, including efficient access to care, high quality health information, and control of their health information (although some do not want their information on the Internet). He noted the overlaps and common themes between this initiative and the Committee’s NHII project. In marketing the portal, the DoD uses a theme important to its beneficiaries: “Take Command of Your Health Care.” The application most popular with users is the ability to make appointments through the primary care manager online. A commercial content vendor is providing health content. There is also an online pharmacy service with a drug-drug and food-drug interaction checker, and a personal-entry health journal. Patients eventually will be able to choose whether to give providers access to their personal health journals.
The platform is scalable so it can be rolled out quickly. Several features will be added in the next year, such as the ability for providers to access various forms of information remotely. Beneficiaries have indicated an interest in patient-provider e-mail communication, but DoD will go into this “very, very slowly” because of the security issues involved.
The system was recently alpha-tested. There are 3,000 users, including about 800 physicians and 2,400 patients, and 85 more hospitals will join in the next few months. The plan is to include all 600 DoD hospitals by the end of 2002. The main steps in implementation involve training, management, and marketing, and technical support; there is little hardware to deploy. Capt. Kelly described the organizational infrastructure to mount this effort, which involves 15 regions around the world, each with a “lead agent” that coordinates with regional facilities and is responsible for parts of the portal specific to the region. The lead agents also assure that local facilities satisfy DoD requirements. The hospitals, clinics, and providers do “most of the heavy lifting,” including training, local marketing, reconfiguring business processes, developing a home page, providing call-center support, and keeping links current. It takes about 60 days to prepare an institution to implement online services. The DoD provides many materials to local affiliates, including marketing materials and millions of pages of health information content, 10 percent of which is available in Spanish. Some alternative medicine information is available, but with disclaimers advising the user to check with the doctor before using it.
Capt. Kelly then showed the Committee screen-shots of the portal (which can be accessed at www.tricareonline.com, although visitors cannot be able to log in as a registered user). He described the rigorous and careful developmental and decision-making process within DoD, including consulting with potential users about what they want. He noted that the approach to registration is especially relevant to the national health information infrastructure discussion. The DoD found it “totally impractical” to do PKI at this point, given its limited budget (its total budget for this initiative is just under $2 million) and the trouble people have remembering their passwords. Instead, it is balancing what is on the portal with the level of security it can offer. Currently, the transmission of information is encrypted from the browser to TRICARE Online. Only people in the DoD database are allowed to establish an account. As security increases, new capabilities will be added. By next summer, they hope to start face-to-face authentication with a trusted agent, giving access to new applications. It will be several years before digital certification is achieved.
Capt. Kelly reiterated that the current emphasis in this initiative is to develop a common infrastructure. He then invited questions.
Discussion
The first question led to comments about DoD’s strategy for integrating the portal with legacy systems, a process expected to take a long time. The first priority is to establish it as the dominant Internet portal for the military health system. To another question, Capt. Kelly said that the portal group is separate from CHCS, although the latter is its core legacy application. The two are on convergent paths, but are managed separately.
Asked about evaluation plans, Capt. Kelly described both “hard” and “soft” metrics - the former including the number of users and number of appointments made, and the latter relating to customer satisfaction. The same focus groups consulted in the beginning are being asked what they think of the portal’s usability, for example.
Regarding the VA’s GCPR project, he said it is not currently helpful because the GCPR is linking laboratory, pharmacy, and radiology data and DoD will not do anything with these data for 12 to 18 months. There have been, and will be, talks about how to link the two initiatives. He later noted the value in the GCPR work around defining standards, which may in turn influence commercial vendors. He stressed the centrality of two functions: common secure communication transactions and a common set of standards that are compatible with the diversity in the health care system. Asked about the DoD’s plans for making the portal available to providers for HIPAA transactions, he said the X12 standards will be key enablers eventually, though they will be “immensely painful to implement over the next year or two.” The DoD’s goal is to allow any authenticated provider to enter claims information and be routed to its claims system, using an 835 and 837. The challenge is routing for the providers who must interact with several different payers.
Dr. Cohn thanked Capt. Kelly for the briefing and noted that the DoD initiative represents an emerging piece of the National Health Information Infrastructure.
REPORT OF THE SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
Mr. Rothstein presented the revised draft of the letter to the Secretary, prepared by the Subcommittee in response to the previous day’s discussion. He read the letter aloud in its entirety, pausing to take comments and calling attention to the changes. The Subcommittee was asked to strengthen the introductory statement recognizing researchers’ anxiety that the intent of the privacy rule will be misconstrued and restricted access to data will undermine potentially important research. A few other minor modifications were suggested. On one point, Mr. Rothstein explained that the Subcommittee did not reach consensus on the issue of de-identification. The Committee engaged in a long discussion about the thrust and phraseology of its sixth recommendation, on making the research provisions of the privacy rule a priority for the HHS education and outreach efforts.
The Committee then passed a motion approving the revised letter, conditional on the further revisions recommended by the Committee. The newly revised letter will be distributed to the full Committee by e-mail for comments, which will be referred to the Executive Subcommittee for final action. The final letter will be posted on the NCVHS Web site.
Mr. Rothstein thanked Mr. Fanning, Ms. Horlick, and Dr. Fitzmaurice for their work with the Subcommittee on the foregoing letter. Dr. Cohn, in turn, thanked Mr. Rothstein for his leadership. A two-day hearing will be held in January on fundraising and marketing.
UPDATE ON NCHS STATISTICAL ACTIVITIES: Dr. Ed Sondik, Director
Dr. Sondik noted that NCHS, located organizationally in CDC, is the principal federal health statistics agency. Although it is not tied to any implementation program, it works closely with components of the Department as well as with other federal statistical agencies, academic institutions, states, and the private sector. Over the last decade, its annual budget has risen from less than 80 million to more than 120 million dollars, derived from one-percent evaluation funds and (to a much lesser extent) direct appropriation. It hopes for a 5 million dollar increase in FY 2002.
Turning to the major data programs, Dr. Sondik said a major theme today is re-engineering. In national vital statistics, which NCHS coordinates for the U.S., recent changes include a move to the 10th revision of the ICD, a new (year 2000) standard for age adjustment (as a result of which some disease rates such as cancer will appear to increase), and expanded content for birth and death certificates. There also has been an extensive program with the certificates to improve data quality. The characteristics of a re-engineered vital statistics program include communications channels and standards, automation at the source, flexibility, service to data providers, open architecture, and security. Re-engineering is necessary because there is a clear need, the foundation is in place, and enabling technology has advanced. The new vital statistics system results from a joint effort between the Center and NAPHSIS. CDC’s development of NEDSS has been a significant step forward in epidemiology and provides a basic model. Key issues are data quality and timeliness all the more so since September 11. NCHS and NAPHSIS have formed a coordinating committee, are identifying resources, and will develop a transition plan. Implementation will take place on a state-by-state basis.
Dr. Sondik then reviewed the Center’s major surveys. The National Survey on Family Growth is beginning its sixth cycle, and will now include men. The next cycle will be in 2005. This and the Longitudinal Survey on Aging are critical, though less well known, surveys that help give a picture of the nation’s health. The National Health and Nutrition Examination Survey (NHANES) began a new round in 1999 and now does clinical exams of an annual representative sample of the U.S. population. The intent is to keep the survey in the field all the time and to produce some data on a biennial basis. A new communication system and statistical design make it possible to get the data out much more rapidly than before. 5,000 people are seen in three mobile exam centers. Complete data are released in about a year. Dr. Sondik noted that the response rate has been steadily improving, to its current 90 percent rate. Annual information includes environmental exposures, done in collaboration with the National Center on Environmental Health. The 2002 survey is expected to link to a USDA survey on food intake, to do HPV testing on women, and possibly to measure physical activity. The standard exam also includes thorough dental and audiology exams. “Community HANES” has a van designed to go to areas where the larger HANES trucks cannot go. When resources are available, it will be used in less accessible places such as inner cities and Indian reservations. This survey will run parallel to NHANES.
The National Health Interview Survey (NHIS) is at the core of the Department’s data collection efforts. It surveys about 40,000 households and 100,000 persons a year and is the chief source of information on disability, the use of health services, risk factors, and self-reported health status. The survey, including the questionnaire and the information system, has been redesigned since 1997. Upcoming supplements include a baseline for Healthy People and ones on children’s mental health, alternative medicine, and cancer screening. Training of interviewers is a priority.
The State and Local Area Integrated Telephone Survey produces information on 78 areas in the U.S. Topics covered include or will soon include early child health, children with special needs, and asthma prevalence.
In the National Health Care Survey, physician and hospital surveys continue, but the long-term care survey has been postponed to redirect resources to an assessment of the healthcare system and data needs.
Dr. Sondik described the Center’s data release activities, stressing the efforts toward early release using the Web. NCHS continues to produce Health United States, which in 2001 focused on comparing urban and rural health; and it helps to produce reports on children’s’ health and wellbeing.
Recent international activities of the Center include the launching of the International Classification of Functioning, Disability and Health and work on international comparisons of national health, the latter partly in reaction to the 2000 World Health Report, which some Americans regarded as not having a satisfactory approach.
NCHS is planning a data users conference for July 2002 and is active in developing summary health measures as part of an interagency committee. It also is developing a policy on the release of microdata. It continues to propose a longitudinal studies program; a major study on children is now being planned as a Department-wide effort. All data collection efforts are linked to state and local activities.
The greatest challenge facing the Center is the balance between confidentiality and data access, especially in those surveys, such as NHANES, that produce voluminous data on an individual. One approach to preserving confidentiality is through data centers that provide a protected research environment. Dr. Sondik noted that NCHS is a partner with NCVHS and the Data Council in developing a vision for 21st century health statistics. Finally, he happily showed a picture of the site on which the Center’s new building will be built in Hyattsville, scheduled for completion in early 2003. Summarizing the major themes and issues, Dr. Sondik mentioned confidentiality, access, release, and the need for more research, along with the need for more resources.
Dr. Newacheck asked Dr. Sondik to talk with the Committee next time about how it could be helpful. This ties to plans for the NCHS Board of Scientific Advisors, currently under consideration in the Department. Dr. Lengerich asked for a briefing on bioterrorism. Dr. Cohn said a briefing on international activities is also scheduled for the February meeting. Dr. Mays asked for a briefing on mental and behavioral health in addition to physical health activities, which Dr. Sondik noted relates to the emerging summary health measures.
Adding to Dr. Lumpkin’s earlier report, Dr. Cohn reported that the Executive Subcommittee recommends that NCVHS serve as an advisory mechanism to the Secretary on the National Quality Report. This will be discussed further in February.
The Workgroup expects to complete much of its report by the end of 2001. It is getting responses to a letter soliciting recommendations.
The Subcommittee plans two sets of hearings in the near future: on patient medical record information standards on December 13-14, and on procedure code issues on February 6-7.
The Subcommittee will hold a hearing on issues on the measurement and collection of race/ethnicity data on February 11-12.
This group will meet December 12 and hopes other NCVHS members will join Workgroup members from 1-5 PM to hear a panel on the issues involved in collecting information on patient safety.
The following topics have been mentioned for the February agenda:
A presentation from GAO on records linkage, originally scheduled for the cancelled September meeting, will probably be deferred. With that, Dr. Cohn adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
John R. Lumpkin, M.D. 3/25/02
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Chair Date