Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
November 16-17, 2005
Hubert H. Humphrey Building
The National Committee on Vital and Health Statistics was convened on November 16-17, 2005, at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Simon P. Cohn, M.D., M.P.H., Chair
Jeffrey Blair, M.B.A.
Justine M.Carr, M.D.
John P. Houston, J.D.
Stanley M. Huff, M.D.
Robert W. Hungate
A. Russell Localio, Esq., M.A., M.P.H., M.S.
Carol J. McCall, F.S.A., M.A.A.A.
Mark A. Rothstein, J.D.
William J. Scanlon, Ph.D.
Donald M. Steinwachs, Ph.D.
Paul Tang, M.D.
Kevin C. Vigilante, M.D., M.P.H.
Judith Warren, Ph.D, R.N.
Absent: C. Eugene Steuerle, Ph.D.
Staff and liaisons
Marjorie Greenberg, NCHS/CDC, Executive Secretary
James Scanlon, ASPE, Executive Staff Director
J. Michael Fitzmaurice, Ph.D., AHRQ liaison
Karen Trudel, CMS liaison
Virginia Cain, NIH liaison
Ed Sondik, Ph.D., NCHS liaison
Steve Steindel, Ph.D., CDC liaison
Katherine Jones, NCHS
Debbie Jackson, NCHS
Carol Bickford, American Nurses Assn.
Lynn Boyd, College of American Pathologists
Marietta Squire, NCHS
Mark Brueckl, Academy of Managed Care Pharmacy
Frank Kyle, Jr., American Dental Assn.
Wanda Jenkins, NCHS
Barry Dickman, VA
Bill Alfano, BlueCross BlueShield
Michael DeCarlo, BlueCross BlueShield Assn.
Marilyn Luke, AHIP
Audrey Burwell, OMH
Cynthia Baur, ODPHP
John Hough, NCHS
- The Committee passed a motion to send a letter congratulating the Department, NLM, FDA and AHRQ on recognizing the importance of package labeling and completing step one of getting simplified pharmaceutical information on the Web.
- The Committee passed a motion approving a letter drafted by the Subcommittee on Standards and Security on the claims attachments NPRM.
- The Committee endorsed the following process for approving an enhanced version of the letter report on PHRs that the Committee approved in September 2005: The NHII Workgroup will review the draft; it will be revised as needed and sent to the Executive Subcommittee, which will approve it for publication.
UPDATE FROM THE DEPARTMENT
· Data Council—James Scanlon, ASPE
- Data standards—Karen Trudel, CMS
- Privacy Rule compliance update—Susan McAndrew, OCR
Mr. Scanlon noted that the American Health Information Community (AHIC) held its first meeting on October 7. Several initiatives are coming forward from FDA, including the posting of the first structured, FDA-approved product label on the NLM’s DailyMed Website on this day. The Department is waiting for final Congressional FY2006 budget decisions. The Data Council has been working on data improvement initiatives in six areas and has initiated a study of data content standards in the major HHS statistical systems. It has employed a consultant to compile in a monograph the current authorities in policies and practices for statistical confidentiality in HHS research and data systems.
Ms. Trudel gave updates on HIPAA compliance. CMS will probably respond to requests from industry to push back the deadline for the attachments proposed rule comment period. It continues to enumerate providers with the NPI. CMS has established an e-Health Steering Committee composed of senior agency executives, to ensure an integrated data strategy in the agency. CMS is developing a summary of the responses to an RFI on its role with PHRs, and then will develop an action plan. It is working on a HIPAA modification rule that will address streamlining issues.
Ms. McAndrew reported that OCR has received more than 16,000 privacy rule complaints, many of them non-jurisdictional, and has closed 68 percent of them. The patterns are similar to past ones. OCR and CMS are coming to closure on the final enforcement rule. A regulatory reform task force has been formed to look at Department-wide regulation. There will be four public hearings around the U.S.
HEALTH CARE CLAIMS ATTACHMENTS NPRM: Briefing and Draft Letter
Ms. Trudel briefed the Committee on the health care claims attachments NPRM, in preparation for a discussion of a comment letter developed by the Subcommittee on Standards and Security. HIPAA legislation requires adoption of claims attachment standards. The proposed rule affects all covered entities. There are five proposed standards, covering the request for information, the response, codes, content, etc. They are for six attachment types, including ambulance, emergency department, and rehabilitation. Four other attachment types are under development by HL7 groups.
The rule is expected to go into effect in about three years and can be used voluntarily until then. CMS has already conducted a pilot and is encouraging others to do so.
Mr. Reynolds then read aloud the Subcommittee’s draft letter on the NPRM and asked for comments. Members and staff suggested several revisions. Following the discussion, the Subcommittee revised the letter in its breakout session. The revised version was presented on day two of this meeting, discussed, and approved.
UPDATE ON OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY, AHIC DEVELOPMENTS—Dr. Brailer
HHS and ONC (the new acronym of Dr. Brailer’s office) have awarded contracts in the areas of:
- Standards harmonization—to create a Health Information Technology Standards Panel
- Compliance certification
- Privacy and security—launching the Health Information Security and Privacy Collaborative
- Nationwide Health Information Network
- Health information technology and health care anti-fraud
- Health IT Adoption Initiative—to produce an annual progress report
The overall purpose is to create entities, organizations and processes whose purpose is to create platforms and leverage points to drive private sector adoption. His office has shifted into a focus on implementation. He introduced the new ONC management team. ONC is proposing a change in how CMS and the OIG enforce the Stark amendment regarding self-referral and anti-kickback rules. At its November 29 meeting, AHIC will discuss potential breakthroughs in several areas and choose a few to target. AHIC expects to have its workgroups operational by the end of 2006 in at least two or three areas.
In the discussion period, members raised questions about how stringent the certification process should be, the proper terminology for ONC and AHIC documents with respect to clinicians (“physicians” or “clinicians”), and the prospects for addressing quality as an AHIC priority.
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY—STATUS OF NHIN REPORT AND RECOMMENDATIONS—Mr. Rothstein
Mr. Rothstein reported that the Subcommittee on Privacy and Confidentiality has spent nearly a year working on privacy and confidentiality issues related to the NHIN, with four hearings around the U.S. Because the issues are very complicated and contentious, the Subcommittee planned this session to brief the full Committee prior to its bringing forward a draft letter at a future meeting. Three Subcommittee members presented the group’s findings and thinking on the following topics:
- Establishing and maintaining public trust in the NHIN
- Regulatory issues
- Secondary uses
- Patient control of information in the NHIN
The group engaged in extensive discussion of the issues raised in the presentations. They will be revisited in future meetings.
SECONDARY USES OF CLINICAL DATA—Dr. Stan Huff, Intermountain Health Care
“Primary” use of data is defined as serving the purpose of providing care and services to a person. “Secondary” use is defined as processing and aggregation for uses other than those for which the data were collected. Dr. Huff said the use of clinically specific data to meet the needs of payers, health care administrators, clinical research and public health has long been a shared vision in medical informatics. The question is what needs to happen to move toward realizing it. After describing the data flow model used at Intermountain Health Care (IHC), he discussed IHC’s secondary uses of data, which include adverse drug event monitoring, nosocomial infection monitoring, rule-based billing, reportable diseases, “How am I doing” reports, and clinical research. In all, the possible secondary uses of data could be for billing, morbidity/mortality reporting, quality reporting and improvement, patient safety reporting, clinical trials, clinical research, to understand population health statistics, and for public health purposes such as biosurveillance and registries. The reasons for NCVHS to study this topic, he said, are to know what has already been done and to determine the most feasible and cost-effective approaches. Dr. Huff outlined a principle for how data collection relates to the secondary use of data, associated with levels of inference. He stressed that there is no expectation that reuse of clinical data will answer all data needs; surveys, public health reporting and other data collection instruments will always be needed. The Subcommittee on Standards and Security has held two hearings on this topic; he summarized the witnesses’ testimony and recommendations.
The group then discussed possible Committee approaches to this topic, raising topics about burden, incentives, data quality, and Committee strategies.
HEALTH STATISTICS AND NATIONAL HEALTH INFORMATION INFRASTRUCTURES—Dan Friedman, Ph.D.
This is Part II of a conversation that began in June with Dr. Friedman about his research into national health information infrastructures. Dr. Friedman noted that this topic relates directly to several others discussed at the present meeting, including secondary uses of clinical data and privacy and consent issues. His project, which was commissioned by NCHS, is an outgrowth of work by the NHII Workgroup and a joint NCVHS/NCHS/Data Council project on health statistics for the 21st century. Its overall purpose is to assess the potential contribution of national health information infrastructures and shared EHRs to health statistics. He studied the national strategies of Australia, Canada, England and New Zealand, identified key themes, and delineated major issues. He has finished his draft report and sent it to about two dozen reviewers. For this presentation, his topics were:
- A recap of the basics of the project
- The current situations in Australia and New Zealand
- Analytic issues in the relationship between national strategies for shared EHRs and health statistics
- Enabling factors, threshold factors and tipping factors to increase the likelihood of successful use of shared EHRs for population health monitoring and research
- Possible next steps for the Committee
Dr. Friedman suggested the following possible next steps for the Committee:
- Continue to name the problem and drill down conceptually, analytically and realistically through actions such as developing a taxonomy of the issues involved.
- Develop policy and a business case for maximizing the potential of shared EHRs for population health monitoring and research that goes beyond syndromic surveillance and bioterrorism.
- Build a research agenda that includes identifying current gaps, developing phased and thoughtful pilots, stimulating public health opinion research into the degree of support for building EHRs and using them for population health monitoring and control, and learning from the experiences of other countries.
In the discussion period, NCVHS members commented on possible analytic approaches, problems with current pay for performance mechanisms, and the continued need for non-clinical data sources for assessing population health.
SUBCOMMITTEE AND WORKGROUP REPORTS; FUTURE MEETINGS
(Please see the last three pages of the detailed summary for these items.)
CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA
Dr. Cohn called the meeting to order. Following introductions, he commented on the current accelerated environment, in which many of the Committee’s longstanding visions are becoming a reality. He cited the Secretary’s 500-day plan and congratulated the Department for moving forward on health information technology (HIT). NCVHS is being invited to be “actively engaged” in this work, and the Executive Subcommittee has been working on how to be most supportive. Other activities of importance include e-prescribing, the claims attachment standard, and the recent recommendations of the Commission on Systemic Interoperability.
UPDATE FROM THE DEPARTMENT
Data Council—James Scanlon, ASPE
Dr. Cohn and the Committee congratulated Mr. Scanlon on his promotion to Deputy Assistant Secretary for Science and Data Policy.
Mr. Scanlon affirmed that the years of collaborative relationship between the Committee and the Department are now bearing fruit. The American Health Information Community (AHIC) met first on October 7 and will meet again on November 29 and in January. Several initiatives are coming forward from FDA. Dr. Fitzmaurice noted that the first structured, FDA-approved product label would be posted on the NLM’s DailyMed Website on this day, starting the pipeline for getting package inserts onto the Web. This, too, emanated from an NCVHS recommendation.
The Department is still waiting for the final Congressional FY2006 budget decisions and hoping for appropriations for its HIT initiatives and population statistics efforts. The Data Council has been working on data improvement initiatives in the following areas: prescription drug utilization and expenditures, health insurance, health care access and utilization at the state and sub-state level, income information in the major statistical surveys, and race and ethnicity data. In addition, it has recently initiated a study of data content standards in the major HHS statistical systems. The study will have three phases: pulling together existing content-oriented standards and looking at best practices and conventions; looking at standards use in the major statistical “workhorse” systems; and identifying directions for future work. Mr. Scanlon said he would keep the Committee apprised of this effort and would be inviting feedback. Finally, the Department has employed a consultant to compile in a monograph the current authorities in policies and practices for statistical confidentiality in HHS research and data systems. The Committee asked for a briefing on the latter study, as well, when it is completed.
At Dr. Cohn’s suggestion, the Committee passed a motion to send a letter congratulating the Department, NLM, FDA and AHRQ on recognizing the importance of package labeling and completing step one of getting simplified information on the Web.
Data standards—Karen Trudel, CMS
Ms. Trudel began with updates on HIPAA compliance. CMS is rejecting any 837 transactions that are not compliant, but about 99.9 percent of the claims are compliant. The attachments proposed rule comment period is scheduled to end on November 22, but CMS will probably respond to requests from industry to push back the deadline by 30 to 60 days. CMS continues to enumerate providers with the NPI. With e-prescribing, now that the final rule has been published CMS is turning its attention to the pilot required in the legislation, working with AHRQ. CMS also has established an e-Health Steering Committee composed of senior agency executives with an interest in e-health, to ensure an integrated data strategy in the agency. It will also coordinate with HHS, especially ONC, and with AHIC. CMS published a request for information on CMS’s role with personal health records. It is developing a summary of the responses, and will then develop an action plan for this area. CMS will probably decide to emphasize working with PHR developers to ensure that their products meet the needs of Medicare and Medicaid beneficiaries.
Asked when the claims attachment final rule could be expected, she said the estimate of 2008 can be regarded as an approximate guidepost. To another question, she said CMS was still committed to its Medicare beneficiary portal experiments in Indiana.
Dr. Cohn noted that NCVHS has gone on record in support of streamlining the processes relating to HIPAA and other regulations. He hailed the evidence that CMS is considering an approach of backward compatibility. Ms. Trudel said CMS is also working on another HIPAA modification rule that will address streamlining issues.
Privacy Rule compliance update—Susan McAndrew, OCR
OCR has received more than 16,000 privacy rule complaints, many of them non-jurisdictional, and has closed 68 percent of them. The patterns are similar to
past ones. About 250 cases have been referred to the Department of Justice. Ms. McAndrew and Ms. Sanchez have talked with Mr. Houston and the Subcommittee on Privacy and Confidentiality about mining the data to discern patterns and lessons. OCR agrees with the recommendations of the California Health Care Foundation on the need for public education, issued in a recent report based on a privacy survey, but it does not see a basis for its recommendations about enforcing HIPAA.
On the regulatory front, OCR and CMS are coming to closure on the final enforcement rule. A regulatory reform task force has been formed to look at Department-wide regulation, and has asked for public comment on the costs imposed by Department regulations. There will be four public hearings around the U.S. OCR is also talking with AHRQ about enforcement issues and others raised by the Public Safety and Quality Improvement Act.
Mr. Rothstein suggested that OCR create a feedback loop whereby it can use data about complaints to help guide its enforcement assistance and outreach activities. Ms. McAndrew said OCR is interested in making more programmatic use of the information, which is now designed only as a management monitoring tool.
BRIEFING ON HEALTH CARE CLAIMS ATTACHMENTS NPRM—Ms. Trudel
Dr. Cohn explained that after a briefing by Ms. Trudel, the Committee would discuss a letter developed by the Subcommittee on Standards and Security.
Ms. Trudel reiterated that the comment period on this NPRM would probably be extended. An attachment is the additional clinical or administrative information that a payer needs from a provider to adjudicate a claim. The current, manual process is inefficient and expensive. HIPAA legislation requires adoption of claims attachment standards. The proposed rule affects all covered entities. There are five proposed standards, covering the request for information, the response, codes, content, etc. They are for six attachment types, including ambulance, emergency department, and rehabilitation. Four other attachment types are under development by HL7 groups.
Essentially, Ms. Trudel said, there are two variations in attachment data in regard to business processes—the human decision variant and the computer decision variant. The proposed standards allow for both; and both encourage participation in some level of electronic attachments. She showed a flow chart for the claim, attachment request, and attachment response showing different outcomes. The rule is expected to go into effect in about three years, and can be used voluntarily prior to that date. CMS has already conducted a pilot and it is encouraging others to do the same.
In response to a question, Ms. Trudel said even the basic level of standards use being proposed is a significant advance over current practice. Asked if there is a roadmap for future steps, she said future steps “probably should not be taken in the HIPAA arena”; rather, industry, health IT and EHR adoption processes will be allowed to move it along. She affirmed that CMS chose not to be very prescriptive with this standard; if the industry finds a need for more stringency, the modification process can be used. She added that this is the first instance in which the HIPAA administrative transaction world meets up with the CHI clinical standard world, forming part of the bridge from administrative data to EHRs. To another question, she said CMS came up with the six types of attachments based on an analysis of which have the most volume and thus would be most useful. Asked if providers can send an attachment in anticipation of a customary request, she said this was considered but the plans discouraged it. The solution is that plans can tell providers in advance what information they want sent with the claim.
LETTER ON HEALTH CLAIMS ATTACHMENTS NPRM—Mr. Blair and Mr. Reynolds
The Subcommittee on Standards and Security co-chairs presented a draft letter on the claims attachments NPRM for review. Mr. Blair explained that the Subcommittee chose not to duplicate content covered by a similar letter by NUCC and NUBC. Dr. Cohn added that a wide swath of the industry is probably providing comments. Mr. Reynolds then read the letter aloud, asking for comments after every paragraph. Members and staff suggested several revisions. A broad issue addressed in this discussion and in the letter concerns the possibility of new, streamlined processes and structures for creating and modifying standards. Following the discussion, the Subcommittee revised the letter in its breakout session, for reconsideration on day two of this meeting.
UPDATE ON OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY, AHIC DEVELOPMENTS—Dr. Brailer
Dr. Brailer announced that the new acronym for his office is “ONC.” He then briefed the Committee on six new contracts, a policy change, and AHIC activities. HHS has awarded contracts in the areas of:
· Standards harmonization—to create a Health Information Technology Standards Panel. ONC has directed that the process be business-driven, not data-driven—i.e., “the pain of standardization” must be linked to problem-solving benefits.
· Compliance certification—to develop criteria for what constitutes an ambulatory electronic health record, focusing on functions. A prototype is due by July 2006. Inpatient EHRs will be the next step, followed by national network architecture.
· Privacy and security—launching the Health Information Security and Privacy Collaborative, comprised of state leaders and looking at desirable state-level policies and procedures in a digital world.
· Nationwide Health Information Network—four projects, chosen from more than 80 proposals to create NHIN prototypes. Dr. Brailer likened the desired outcome to the cellular telephony network through which diverse cell phones connect and interoperate.
· Health information technology and health care anti-fraud—following on an ONC report that lays the groundwork for “preparing for the world of cyberfraud” by looking at legal regulatory issues, business practice questions and economic models. The objective is ultimately to prevent fraud at the source of care.
· Health IT Adoption Initiative—to fund an annual report on adoption, showing whether the policies are working and providing detailed comparative data by region, population, and so on, based on a meta-analysis by an expert panel. The first report is due in mid-2006.
Dr. Brailer said the overall purpose of these initiatives is to create entities, organizations and processes whose purpose is to create platforms and leverage points to drive private sector adoption. His office has shifted into a focus on implementation. He introduced the new management team at ONC.
Regarding the policy change, ONC is proposing a change in how CMS and the OIG enforce the Stark amendment regarding self-referral and anti-kickback rules. The proposed changes were published in the October 5 Federal Register.
At its second meeting on November 29, AHIC will discuss potential breakthroughs in the following areas and choose a few to target:
- Consumer empowerment
o My Personal Health Record
o My Medication History
o My Health Record Locator
o My Registration Information
- Health improvement
o Quality monitoring and reporting
o chronic disease monitoring
- Public health protection
o Biosurveillance and pandemic surveillance
AHIC expects to have its workgroups operational by the end of 2006 in at least two or three areas. It and the American Health Information Community will work closely with NCVHS.
Dr. Cohn was the first of several Committee members to congratulate Dr. Brailer for the extraordinary accomplishments of his office over a short period of time.
In response to a question about the prospects for interconnecting telehealth, health information exchange networks and e-prescribing, Dr. Brailer commented on the past proliferation of bilateral communication silos in the health arena and the vision for a generalized environment enabling a range of interoperable functions. He said ONC would push the contractors to go as far as they can in the latter direction.
Dr. Warren urged that ONC and AHIC documents speak not just of and to physicians but of/to all clinicians who impact health care. She proposed use of the inclusive word “clinician” rather than “physician.”
Responding to a question about the revised anti-kickback regulations, Dr. Brailer said one of the questions on the table for the comment period (which ends in late winter) is what unintended consequences might result from the change.
Asked about the certification process and how stringent or inclusive to make it, he said that after considering the full range of alternatives, the Department chose to view certification as a minimal requirement, reasoning that it is up to markets to stimulate innovation and sort out price/performance issues above that minimum level. He added that the certification criteria will have to evolve and become more stringent over time.
Asked about prospects for advancing or at least linking to quality measurement initiatives, Dr. Brailer said that if AHIC ranks quality measurement as one of its priorities, it would proceed, as with other priorities, to build infrastructure, deal with regulatory barriers, and look at cultural and financial/economic issues. However, the quality community has cautioned that “there is a lot more here that’s outside the scope of IT than is inside.” The quality effort has to begin with the key constituents, he said, and it may not yet be ready for “the software engineers.”
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY—STATUS OF NHIN REPORT AND RECOMMENDATIONS—Mr. Rothstein
Mr. Rothstein reported that the Subcommittee on Privacy and Confidentiality has spent nearly a year working on privacy and confidentiality issues related to the NHIN, with four hearings around the U.S. involving numerous, diverse witnesses. Because the issues are very complicated and contentious, the Subcommittee planned this session to brief the full Committee prior to its bringing forward a draft letter at a future meeting. Although the Subcommittee does not agree on everything, the letter represents areas of consensus. Some of the recommendations appear inconsistent because they allow for different options and outcomes. Three members presented the Subcommittee’s thinking on the following topics:
- Establishing and maintaining public trust in the NHIN
- Regulatory issues
- Secondary uses
- Patient control of information in the NHIN
Establishing and maintaining public trust in the NHIN
Mr. Reynolds took the first topic. He noted the big paradigm change to EHRs and the NHIN, along with the public’s concerns about the privacy, confidentiality and security of their health information and their failure to see potential personal benefits from this change. Establishing public trust must begin with more education, demonstrating the potential health-improvement benefits for individuals. In addition, meaningful public participation is essential, together with an ongoing, publicly visible program of measuring and assessing the effectiveness of privacy protections. The Subcommittee’s recommendations will be based on these criteria.
Dr. Steinwachs suggested that the term “patient safety” has more traction with people than the term “quality.” He also suggested that social marketing for the NHIN use real-life examples of people who have benefited from HIT (with identities disguised).
Mr. Houston commented that the NHIN is being developed to improve quality and safety as well as efficiency; the Subcommittee’s focus on privacy is intended to remove a potentially great inhibitor to this progress if people do not want to participate.
To a comment about publicizing how many people’s health information was affected by Hurricane Katrina, Mr. Scanlon said there is not good enough information to state this reliably. Dr. Carr suggested using modeling to make the public case about how EHRs could have changed the outcomes for Katrina victims, and Dr. Tang suggested juxtaposing this with VA enrollees’ intact electronic records.
Dr. Steindel asked about the thinking behind using the terminology of “NHIN” rather than “NHII”; Mr. Rothstein said the Subcommittee wants to be directly relevant to the NHIN, as requested by the Department.
Recalling earlier comments about setting a minimum for certification, Dr. Scanlon said the Committee should continually advise the Department that for the NHIN to be successful, the minimums must be high enough to assure public confidence in the adequacy of the safeguards for their personal health information (PHI).
Disclosures and regulatory issues
Mr. Houston then presented the second and third topics. On disclosures, he noted that there are two types: (1) disclosures for primary use for treatment, payment or health care operations (TPO); and (2) disclosures for secondary uses, pursuant to a “compelled authorization.” In the first area, the Subcommittee believes that not all individuals need access to all of a person’s PHI to deliver care. This suggests the need for some type of role-based access criteria in the NHIN. This principle needs to be inherent both in the NHIN structure and in EHRs themselves.
Regarding secondary uses, individuals are sometimes asked to disclose PHI for purposes other than TPO; this permission is “compelled” in the sense that they must authorize access in order to get (for example) insurance or a job. Often these authorizations are overly broad, suggesting the need for a mechanism to limit authorizations to the information that is truly needed, based on “contextual access criteria.” The Subcommittee would like HHS to support research into such schemes.
Mr. Scanlon suggested that the Committee think in terms of suggesting to the Department a set of principles to govern the direction of privacy issues in the NHIN. He cautioned against locking in specific recommendations that assume particular applications. Proposing principles would leave the door open for subsequent requests from the Department.
Dr. Cohn suggested the title “Privacy by Design” for the Subcommittee’s report. He noted that proposing further research and/or demonstration projects might also be useful, to determine whether certain ideas are doable.
Mr. Rothstein stated his belief that “the greatest threat to health care privacy is through lawful compelled authorizations” and said the Subcommittee’s approach in this area is akin to the principle of minimum necessary. Using the example of life insurance, he noted the way EHRs might improve privacy protections by making it possible to send an extracted set of relevant data elements.
Dr. Steinwachs commented on the need for a mechanism to determine the “useful life of medical information” rather than “automating everything.” He said he feared the emergence of a new industry to automate old records, as well as the potential for inaccuracies in the record.
Moving on to regulatory issues, Mr. Houston said it has three areas: jurisdiction, procedures and enforcement. The Subcommittee used the HIPAA privacy rules as a reference point, noting both consistencies and incompatibilities. Regarding jurisdiction, there are many conflicts among the sources of health privacy regulation, an issue that will be more pronounced with the NHIN. The Subcommittee favors a single national standard to facilitate compliance, and it applauds the Department’s awarding of a contract to study state variations. The Committee also believes coverage should be extended beyond current HIPAA covered entities because PHI loses protection when it passes from covered to uncovered entities.
Regarding procedures, the Subcommittee stresses the need for meaningful participation of a cross-section of the population in the development of the NHIN, to ensure that their interests are represented. In addition, there must be fair information practices so people can know of the uses of their information and be able to correct errors and have a means of redress for harm. Patient notification in the event of a breach is important and will be addressed in a separate letter.
Regarding enforcement, strong enforcement and meaningful penalties are essential to the NHIN. The Subcommittee believes that many people regard the enforcement provisions and/or practices within HIPAA as inadequate. There should be progressive and severe penalties for egregious violations, and a variety of enforcement mechanisms. In addition, individuals need some form of direct remedy if they are harmed.
Dr. Tang then presented the topic of secondary uses of PHI, defined as confidential health information used for purposes other than direct patient care. While many such uses are essential, the indiscriminate use of this information poses very serious privacy risks. The entities not covered by HIPAA are the Subcommittee’s central concern. Its primary objective is to ensure that consumers trust the NHIN and trust that their PHI will not be used for purposes outside their consent. As a primary principle, the Subcommittee sees the need for uniform, comprehensive privacy policies that apply to any entity with access to confidential health information anywhere, with the protection following the data and with everyone accountable. The problem of outsourcing to foreign territories is recognized but unresolved.
Patient control of health records in the NHIN
Mr. Rothstein said this final topic has caused the most difficulty because of the opposing values involved. That is, promoting privacy, autonomy and choice suggests flexibility; but greater flexibility creates more complexity and cost and makes it hard for patients to understand and for providers to comply. In addition, health benefits are lost to individuals and society if the NHIN is not comprehensive. He posed two questions:
First, to what extent, if any, should individuals have the right or ability to elect not to have their health records disclosed through the NHIN? On this, the Subcommittee is unanimous that inclusion in the NHIN should not be mandatory. However, the members do not agree about whether the right should be exercised by opting in or opting out. In either case, public education will be critical.
Second, to what extent, if any, should individuals have the right or ability to exclude certain information from transmission via the NHIN, or to block certain information to providers or other recipients? Subcommittee members do not agree on the answer. Mr. Rothstein gave some of the arguments for and against allowing exclusion (blocking) of specific information. If blocking is allowed, the next question is how information can or should be blocked. The Subcommittee members have differing views on this, as well.
Many Committee members commented on this issue. Dr. Steinwachs noted the AAFP’s idea of a continuity of care record, which might offer a middle ground between wide information access and none. Mr. Rothstein said he personally favors this, but medical association representatives have stated their opposition to any limitations on information access for treatment providers. Ms. McCall noted the tension between what is desired and what is possible. She suggested initially setting aside questions of what’s possible and identifying “true north” in terms of privacy principles, and then asking the HIT community to determine how close we can get to this ideal. She also commented that patients would have to be made aware of the consequences of blocking certain information.
Dr. Vigilante commented on the risks of limiting information to providers and said that clinicians at least must be alerted that something has been blocked. The group also mentioned the possibility of mechanisms for requesting additional information or even “breaking the glass” in emergencies. Dr. Carr echoed others’ concerns about blocking any information for clinicians and stated her opposition to the blocking option, saying “either you’re in or you’re out,” so there is a clean dataset. Mr. Blair commented on the urgent need to find out more about consumers’ fears and perceptions on these issues so policy makers do not have to speculate about this.
Mr. Rothstein said there would be ample time to weigh in on these issues in the future. Ms. Greenberg pointed out that even if not in complete agreement on these complex and sensitive issues, the Committee can make a contribution simply by laying out the issues and the different perspectives on them. The decisions about them will be made in a political environment. Dr. Cohn agreed, and thanked the Subcommittee on Privacy and Confidentiality for their provocative presentation.
SECONDARY USES OF CLINICAL DATA— Dr. Stan Huff, Intermountain Health Care
Dr. Huff, an NCVHS member, is a physician with Intermountain Health Care (IHC). He noted that the NHII roadmap speaks of the use of clinically specific data to “meet the needs of payers, health care administrators, clinical research and public health.” This has long been a shared vision in medical informatics. The question is what needs to happen to move toward realizing it.
“Primary” use of data is defined as serving the purpose of providing care and services to a person. “Secondary” use is defined as processing and aggregation for uses other than those for which the data were collected. Dr. Huff showed three data flow diagrams—of the typical IHC clinical data flow for primary, an example of secondary use (a cancer registry), and a possible model of fully automated future use. Typical IHC clinical data flow features an interface engine and flow into a clinical data repository with standard interfaces that enable access and use of data, using standard terminologies. The clinical data repository is used for real-time patient care, and the data warehouse is the site of cross-population analysis and research. IHC has ten FTEs maintaining the terminology and 26 maintaining the interfaces.
Dr. Huff then discussed the secondary uses of data at IHC, which include adverse drug event monitoring, nosocomial infection monitoring, rule-based billing, reportable diseases, “How am I doing” reports (e.g., hemoglobin A1C comparisons), and clinical research. Using this approach, IHC detected nearly ten times as many adverse drug reactions as were reported through a manual process. The HgbA1c reports are “a remarkable motivator for physicians,” and they have seen a significant change in behavior and better care. He described some of the research that provided the evidence for changing clinical care—e.g., on induction of labor prior to 39 weeks. In all, the possible secondary uses of data could be for billing, morbidity/mortality reporting, quality reporting and improvement, patient safety reporting, clinical trials, clinical research, to understand population health statistics, and for public health purposes such as biosurveillance and registries.
Reasons for NCVHS to study this topic, he said, are to know what has already been done and to determine the most feasible and cost-effective approaches. It may be an appropriate topic for the Quality Workgroup and/or the Subcommittee on Populations. Using the example of an immuno-compromised patient, Dr. Huff then outlined a principle for how data collection relates to the secondary use of data, associated with levels of inference. The ability to infer initial, perception-based clinical information from an ICD code or DRG grouping, he said, is very limited. Determining the accuracy of each step of inference requires knowing the primitive data derived from initial perceptions. This makes it possible to apply precise logic to what was observed. The closer one gets to the actual observations, the more quality assurance is possible using the data. The down side is that costs and burden also increase the closer one gets to observations. He proposed that there could be a set of shared public computable rules or algorithms to assign classifications or create inferences (e.g., Chris Chute’s “aggregation logics”). He also noted as an “interesting rule” that there must be more than one secondary use of the data to justify the cost of collecting the data. Finally, he stressed that there is no expectation that reuse of clinical data will answer all data needs; surveys, public health reporting and other data collection instruments will always be needed.
The Subcommittee on Standards and Security has held two hearings on this topic, and Dr. Huff summarized the testimony and recommendations of the following sources (see transcript for details):
- Clem McDonald
- James Campbell
- James Cimino
- Kent Spackman
Dr. Huff then invited fellow members to discuss what NCVHS should do now.
Dr. Cohn observed that secondary use has been a “fundamental tenet” for NCVHS for more than a decade, and much of its past work relates to it. The question now is what barriers remain and how to “bust through” them. It was noted that several subcommittees and workgroups have shown interest in this topic, raising the question of whether this is a topic for the full Committee.
Dr. Tang said the way to compensate the people collecting the data is to make the information useful to them. This will only work, he said, by creating a business case for secondary data uses, such as pay for performance. Ms. McCall asked Dr. Huff if IHC clinicians regard their improved performance as a value, and he said he thought “most of them” like getting information that helps them provide better care.
On the burden issue, Dr. Carr pointed out that health care institutions have a large and costly new burden of collecting performance indicators that require chart review. This makes the case for electronic processes more compelling. She observed that IHC has a much more sophisticated human and decision support infrastructure than most institutions. The Quality Workgroup wants to inform the architecture so that the processes of developing performance metrics and building the EHR intersect.
Mr. Blair commented on the importance of providing incentives for collecting clinically specific data from patient care, with enough incentives to provide a tipping point for quality. Dr. Huff agreed and said there is also merit in the idea of “fee for data.”
Mr. Scanlon hailed Dr. Huff’s presentation for showing that “the new world is really possible.” He predicted “a huge shift in the balance of power” with new mechanisms and the inevitability of strong resistance from those losing power. He cautioned against “reaching too low” to effect the kind of radical changed needed, and suggested intervening at the point of decision making and informing providers, patients and payers about what is possible. He urged the Committee to think strategically about what actions will have the greatest impact.
Mr. Localio discussed the secondary use problems he sees, and foresees, related to poor quality data. Using anecdotes of missing data to illustrate his point, he cautioned against assuming a connection between quality and computerized data collection.
Mr. Hungate commented that for the system to work, the data being collected must be worthwhile to the clinicians recording it, and they must trust the information system in the same way that patients must trust privacy and confidentiality. He asserted that payment system change is a big piece of the solution, and that patients must have information to help them make treatment decisions.
On how the Committee should address this topic, Ms. McCall advocated making it a full Committee topic at least initially. She asked what the Committee should do that is different from what is being done with the NHIN. Dr. Cohn commented on possible ways to move forward, and stressed that the Committee should be instilling a longer-term vision into the work in this area.
The Committee then recessed into breakout sessions, to reconvene the following day.
Mr. Reynolds presented the revised version of the letter from the Subcommittee on Standards and Security on the claims attachments NPRM. He read the revised sections aloud; one minor revision was suggested and accepted. The Committee then passed a motion approving the letter.
Dr. Cohn then asked the Committee’s endorsement of the following process for approving an enhanced version of the letter report on PHRs that the Committee approved in September 2005: The NHII Workgroup will review the draft; it will be revised as needed and sent to the Executive Subcommittee, which will approve it for publication. The Committee voted to accept this process.
HEALTH STATISTICS AND NATIONAL HEALTH INFORMATION INFRASTRUCTURES—Dan Friedman, Ph.D.
Dr. Cohn reminded the group that this is Part II of a conversation that began in June with Dr. Friedman about his research into national health information infrastructures.
Dr. Friedman noted that this topic relates directly to several other topics discussed at the present meeting, including secondary uses of clinical data and privacy and consent issues. Since June, he has finished his draft report and sent it to about two dozen reviewers. His topics for this presentation were:
- a recap of the basics of the project
- the current situations in Australia and New Zealand
- analytic issues in the relationship between national strategies for shared EHRs and health statistics
- possible next steps for the Committee
This project, which was commissioned by NCHS, is an outgrowth of work by the NHII Workgroup and a joint NCVHS/NCHS/Data Council project on health statistics for the 21st century. Its overall purpose is to assess the potential contribution of national health information infrastructures and shared EHRs to health statistics. He studied the national strategies of Australia, Canada, England and New Zealand, identified key themes, and delineated major issues.
Dr. Friedman stressed that the key terms are not self-defining or even commonly defined. He echoed the Committee’s September 2005 letter report on PHRs, that the focus should be on the attributes. Those that he deals with in his report are: longitudinal, cradle to grave collection of patient-centric, identifiable data that are cross-provider and cross-sector. This is not necessarily the desk-top record and not necessarily data kept in a single location. Like the NCVHS report on 21st century health statistics, he defines health statistics as numerical data that characterize the health of a population and the influences that affect its health. The term is used synonymously with “population health monitoring and research,” used by other countries.
Australia illustrates the conceptual, bureaucratic and organizational changes under way in this area. The country’s Health Connect Program Office launched five pilots relating to national strategies for shared EHRs in 2002. The Health Connect business architecture was made public in November 2004, and in early 2005 a quasi-governmental organization called the National eHealth Transition Authority (NEHTA) took over many of Health Connect’s responsibilities. NEHTA has adopted a market-driven approach, and it is not clear whether any of the initial vision laid out by Health Connect remains in place. NEHTA is continuing the earlier work plan to develop templates for event summaries. Its working definition of EHRs and shared EHRs is not clear.
An important element of the November 2004 model was patient participation and informed patient consent for the collection, disclosure, access and use of PHI. In contrast, NEHTA states that it “does not support an emphasis on consent” and it “argues that consent and privacy requirements must be assessed against specific initiatives and proposals.” Dr. Friedman believes they are trying to disaggregate the consent issue and move away from Health Connect’s “maximally flexible model,” perhaps primarily for technical reasons, but he has not succeeded in getting direct answers to his questions and public information on these activities is very limited.
Mr. Blair observed that the situation in Australia is clearly not static, and he asked Dr. Friedman to focus on the lessons for the U.S. from the evolution they are undergoing. Dr. Friedman cited a statement in Australia’s equivalent of Health US, reflecting on the limits of Health Connect for population health research monitoring. It cites voluntary participation, the nature of health event summaries, and the lack of harmonized standards for clinical and population health data. He believes there is still a commitment to connecting for health, but that the nature of the commitment has changed. Originally, health statistics were to derive from a national data store to which data would have been voluntarily submitted; it is unclear whether the national data store is still part of the strategy.
Moving on to New Zealand, Dr. Friedman said it is a very wired country: all hospitals and nearly all GPs use electronic patient management software. However, New Zealand has adopted an incremental approach to shared EHRs that emphasizes getting the basics right. They start with a population health strategy, from which their health systems strategy is derived; the HIT strategy is derived from that. New Zealanders speak disparagingly of “the Holy Grail of EHRs” and reject the notion of a device that holds all medical information on a patient. The emphasis in the national strategy is on individual patient care, and they discount having a single national repository for all of an individual’s identifiable health information. Instead, they envision three levels of data storage—local systems (supporting personalized care), regional systems (key event summaries and abstracted encounter information) and national systems (core systems with shared data and processes throughout the health and disability sector, owned and operated by the Ministry and Health, including the National Health Index and a warning system).
Ms. McCall speculated on what the U.S. could learn from all this thinking about structure and governance. Mr. Scanlon observed that the U.S. uses a market-based strategy that is not top-down.
Mr. Blair speculated that New Zealand’s automated health information systems, which are at least a decade old, do not have transformative capability but rather have automated existing processes, possibly causing disenchantment. Dr. Friedman agreed that this system, for all its penetration, does not translate into interoperable electronic patient records. He added that the New Zealand system does include nationwide individual data collection streams such as mortality, inpatient discharges and cancer registries. At present, extraction is not automated and there does not appear to be a strategy for automating these collections. Deidentified data can be used without individual consent, with normal approvals.
Moving to analytic issues, Dr. Friedman observed that in health statistics, there are both numerator and denominator issues as well as the need for a match between the numerator and denominator. He cited these issues:
- Penetration of shared EHRs
- Data quality
- Data completeness
- Patient consent (“one of the most basic issues”)
- Unique personal identification
- The need for known denominator characteristics
He then discussed these overarching issues:
- Population health is not equivalent to health care.
- EHRs will be useful for health statistics only if they include the same variables and mapped code sets to existing data.
- It is not known how a national data repository could be used for analytic purposes.
- Culture changes are needed on the part of clinicians, public health and the population.
- How can secondary uses be built into market strategies?
Dr. Friedman then commented on what he regarded as enabling, threshold and tipping factors to increase the likelihood of successful use of shared EHRs for population health monitoring and research. He stressed that these are not intended as recommendations.
- Health system enabling factors
o Greater funding of the health care system by government
o A lower percentage of uninsured individuals
o Higher ratio of GPs to specialists
o Greater central coordination of the health system
o Greater control of the health care market by the government
- Health information system enabling factors
o Closer relationship between the provision of health care information from data sources and the conduct of population health monitoring
o Clinician incentives for adopting and using shared EHRs, especially for secondary purposes.
- Threshold factors (defined as those without which successful use of shared EHRs for population health monitoring and research may fail)
o Business threshold factors
- Explicit inclusion of population health monitoring and research as an integral component of the national strategy and mission for shared EHRs
o System threshold factors
- National strategy for shared EHRs must include integrated electronic provision of data and integrated data flows from diverse health care sources for multiple purposes.
- Unique patient identification
- Tipping factors to maximize the potential for successful use of shared EHRs for population health monitoring and research
o Existence of a single predominant payer
o Salary-based reimbursement for clinicians
o Mandated use of shared EHRs
o Mandated standards
Finally, he shared his thoughts about possible next steps for NCVHS. The first is to continue to name the problem and drill down conceptually, analytically and realistically through actions such as developing a taxonomy of the issues involved. The second is to develop policy and a business case for maximizing the potential of shared EHRs for population health monitoring and research that goes beyond syndromic surveillance and bioterrorism. The third is to build a research agenda that includes identifying current gaps, developing phased and thoughtful pilots, stimulating public health opinion research into the degree of support for building EHRs and using them for population health monitoring and control, and learning from the experiences of other countries.
Responding to a comment, Dr. Freidman said that basic questions need to be addressed about how to move from implementation in a practice, a hospital, a network or part of a state to broader societal issues related to getting data on population health. Asked what lessons can be learned from Australia’s transition, he said that one thing it demonstrates is the extent to which architectural solutions are also political solutions.
Ms. McCall commented that although the uneven landscape of the HIT roll-out will make population health work and analysis difficult, there may be strategic ways to expedite and facilitate this that the Committee should look into. In addition, it may be useful to look into techniques and models being used outside the health statistics arena to deal with highly dimensioned information such as what will emerge through HIT. Dr. Cohn observed that a lot of models already exist within health care, as well.
Dr. Tang expressed concern about “the direction of measurement” and cited the DOQ Project, which raises denominator issues because of its claims basis and definitions. He asserted that we are measuring the wrong thing and creating a big opportunity cost by asking people to implement measurement systems and rewarding them based on administrative data. Dr. Cohn and others noted that this is the kind of problem the Quality Workgroup is addressing. Dr. Scanlon commented that pay for perfomance schemes have no value if they end up creating adverse incentives and a backlash.
Mr. Localio hailed the fact that Dr. Friedman’s presentations helps create reasonable expectations about HIT and its limitations and makes it less likely that resources such as NCHS surveys will be eliminated because they’re viewed as unnecessary.
Mr. Hungate commented on the need to link population health issues to pay for performance, to create more momentum in that direction. He speculated that registries might provide the interface between clinical information and population health assessment. Dr. Friedman referred the Committee to England’s experience.
On Mr. Localio’s point, Mr. Scanlon noted that in the U.S., many people don’t interact with the health system for most of their lives, so public health measures, monitoring systems and surveys will always be needed.
SUBCOMMITTEE AND WORKGROUP REPORTS
Subcommittee on Standards and Security—Mr. Reynolds
The Subcommittee plans to finalize its hearings on the return on investment from HIPAA, have an update on e-prescribing, and have an update on ONC-related items. As deliverables, it plans a letter on ROI and a letter on secondary uses of data and matching patient records.
Subcommittee on Populations—Mr. Localio
The Subcommittee is studying the disaster response capacity of local community health systems and barriers and opportunities related to health data linkages to strengthen measurement of SEP, disability and utilization and cost. It has discussed the possibility of investigating what EHRs and the NHIN can do and what they can’t with respect to population health research and monitoring. Ms. McCall said the Subcommittee on Populations and the Quality Workgroup will share responsibility for that topic, and the report on 21st century health statistics and its model of influences on population health provide an excellent conceptual framework for this work.
Quality Workgroup—Mr. Hungate and Ms. McCall
The Workgroup is holding a hearing on November 18 to help focus its approach to EHRs, the NHIN and quality measurement and improvement. This continues many of the themes addressed in the present meeting. Dr. Friedman will participate as a reactor and Dr. Lumpkin and Dr. Huff will be panelists, among others. The Workgroup is thinking about quality at both the individual and the population levels. Ms. McCall commented on the potential for strategic linkages among the work plans of the various NCVHS subcommittees and workgroups, given the breadth of the issues involved with quality.
Subcommittee on Privacy and Confidentiality—Mr. Rothstein
The Subcommittee has decided to go forward with its research on privacy and confidentiality of the NHIN, focusing in particular on the issue of patient control of health records. It is aiming to complete at least part of a document by February.
The Subcommittee is getting this work done as rapidly as possible, giving priority to issues that affect the design and architecture of the NHIN. Its next topic concerns role-based access restrictions.
NHII Workgroup—Dr. Cohn
The Workgroup is finalizing a version of its report on PHRs developed for a wide audience. It will report in February on its work plan for the coming year.
Executive Subcommittee—Dr. Cohn
The Subcommittee will hold conference calls to coordinate the Committee’s work and plan agendas. Dr. Cohn will represent NCVHS at upcoming AHIC meetings, designating a Subcommittee chair to attend in his stead if he is unavailable so there is continuous representation.
He invited comments on the contents and conduct of this meeting. Dr. Carr expressed appreciation for the opportunities to learn about and discuss key information policy issues that affect all subcommittees and workgroups. The interactions among the members, with their diverse expertise, is especially valuable. Ms. McCall recommended staying open to ways to self-organize other than the Committee’s usual function-based structure, depending on the topic. She noted that some topics such as secondary uses may warrant more cross-disciplinary form of organization. Dr. Cohn noted that the Committee is increasingly using a mixed model, with more issues being brought to the full Committee for work. This, he noted, brings the Committee closer to “the NHII paradigm that we have been talking about.” Dr. Tang advocated having a full-Committee retreat soon, to think about how to maximize synergy among the parts.
Ms. Greenberg and the Committee expressed appreciation to Debbie Jackson for all her behind-the-scenes work, which includes putting together organic agendas and making everything work smoothly and effectively.
Future Agendas—Dr. Cohn
These topics were mentioned as agenda possibilities for February or thereafter, at the full Committee level or in a subgroup:
- Update from HHS on the Data Council’s statistics work and standards
- CMS briefing on RFI responses on PHRs
- Final HIPAA enforcement rule update
- CHI and FHA architecture update (or Subcommittee on Standards and Security)
- Briefing on the status of standards and the mapping among them (NLM)
- Update from CCHIT (or an NCVHS subgroup)
- Status report on the NHIN—Dr. Brailer
- Presentation from CSI on their report
- Briefing by Dr. Sondik and the new BSC liaison, especially on data release and confidentiality issues
- Briefing on WHO and international classifications—Ms. Greenberg
- New chief medical officer, Department of Homeland Security
- Briefing from CMS on pay for performance and performance measurement
After thanking the Committee members and staff for their support and help, Dr. Cohn adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
______/s/__________________________________________February 22, 2006__