Health Information Technology: HHS Has Taken Important Steps to  
Address Privacy Principles and Challenges, Although More Work	 
Remains (17-SEP-08, GAO-08-1138).				 
                                                                 
Although advances in information technology (IT) can improve the 
quality and other aspects of health care, the electronic storage 
and exchange of personal health information introduces risks to  
the privacy of that information. In January 2007, GAO reported on
the status of efforts by the Department of Health and Human	 
Services (HHS) to ensure the privacy of personal health 	 
information exchanged within a nationwide health information	 
network. GAO recommended that HHS define and implement an overall
privacy approach for protecting that information. For this	 
report, GAO was asked to provide an update on HHS's efforts to	 
address the January 2007 recommendation. To do so, GAO analyzed  
relevant HHS documents that described the department's		 
privacy-related health IT activities.				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-1138					        
    ACCNO:   A84260						        
  TITLE:     Health Information Technology: HHS Has Taken Important   
Steps to Address Privacy Principles and Challenges, Although More
Work Remains							 
     DATE:   09/17/2008 
  SUBJECT:   Accountability					 
	     Electronic data interchange			 
	     Electronic health records				 
	     Health information privacy 			 
	     Information disclosure				 
	     Information management				 
	     Information security				 
	     Information technology				 
	     Internal controls					 
	     Medical information systems			 
	     Privacy law					 
	     Privacy policies					 
	     Records						 
	     Right of privacy					 
	     Risk management					 
	     Standards						 
	     Strategic planning 				 
	     Personal information				 

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GAO-08-1138

   

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Report to the Chairman, Subcommittee on Oversight of Government 
Management, the Federal Workforce, and the District of Columbia, 
Committee on Homeland Security and Governmental Affairs, U.S. Senate: 

United States Government Accountability Office: 
GAO: 

September 2008: 

Health Information Technology: 

HHS Has Taken Important Steps to Address Privacy Principles and 
Challenges, Although More Work Remains: 

GAO-08-1138: 

GAO Highlights: 

Highlights of GAO-08-1138, a report to the Chairman, Subcommittee on 
Oversight of Government Management, the Federal Workforce, and the 
District of Columbia, Committee on Homeland Security and Governmental 
Affairs, U.S. Senate. 

Why GAO Did This Study: 

Although advances in information technology (IT) can improve the 
quality and other aspects of health care, the electronic storage and 
exchange of personal health information introduces risks to the privacy 
of that information. In January 2007, GAO reported on the status of 
efforts by the Department of Health and Human Services (HHS) to ensure 
the privacy of personal health information exchanged within a 
nationwide health information network. GAO recommended that HHS define 
and implement an overall privacy approach for protecting that 
information. For this report, GAO was asked to provide an update on 
HHSï¿½s efforts to address the January 2007 recommendation. To do so, GAO 
analyzed relevant HHS documents that described the departmentï¿½s privacy-
related health IT activities. 

What GAO Found: 

Since GAOï¿½s January 2007 report on protecting the privacy of electronic 
personal health information, the department has taken steps to address 
the recommendation that it develop an overall privacy approach that 
included (1) identifying milestones and assigning responsibility for 
integrating the outcomes of its privacy-related initiatives, (2) 
ensuring that key privacy principles are fully addressed, and (3) 
addressing key challenges associated with the nationwide exchange of 
health information. In this regard, the department has fulfilled the 
first part of GAOï¿½s recommendation, and it has taken important steps in 
addressing the two other parts. The HHS Office of the National 
Coordinator for Health IT has continued to develop and implement health 
IT initiatives related to nationwide health information exchange. These 
initiatives include activities that are intended to address key privacy 
principles and challenges. For example: 

* The Healthcare Information Technology Standards Panel defined 
standards for implementing security features in systems that process 
personal health information. 

* The Certification Commission for Healthcare Information Technology 
defined certification criteria that include privacy protections for 
both outpatient and inpatient electronic health records. 

* Initiatives aimed at the state level have convened stakeholders to 
identify and propose solutions for addressing challenges faced by 
health information exchange organizations in protecting the privacy of 
electronic health information. 

In addition, the office has identified milestones and the entity 
responsible for integrating the outcomes of its privacy-related 
initiatives, as recommended. Further, the Secretary released a federal 
health IT strategic plan in June 2008 that includes privacy and 
security objectives along with strategies and target dates for 
achieving them. 

Nevertheless, while these steps contribute to an overall privacy 
approach, they have fallen short of fully implementing GAOï¿½s 
recommendation. In particular, HHSï¿½s privacy approach does not include 
a defined process for assessing and prioritizing the many privacy-
related initiatives to ensure that key privacy principles and 
challenges will be fully and adequately addressed. As a result, 
stakeholders may lack the overall policies and guidance needed to 
assist them in their efforts to ensure that privacy protection measures 
are consistently built into health IT programs and applications. 
Moreover, the department may miss an opportunity to establish the high 
degree of public confidence and trust needed to help ensure the success 
of a nationwide health information network. 

What GAO Recommends: 

GAO recommends that HHS include in its overall privacy approach a 
process for ensuring that key privacy principles and challenges are 
completely and adequately addressed. In written comments on a draft of 
this report, HHS generally agreed with the information discussed in the 
report. 

To view the full product, including the scope and methodology, click on 
GAO-08-1138. For more information, contact Valerie C. Melvin, (202) 512-
6304 or [email protected]. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

HHS Has Taken Steps to Address Privacy Principles and Challenges, but 
It Has Not Fully Implemented an Overall Privacy Approach: 

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objective, Scope, and Methodology: 

Appendix II: Comments from the Department of Health and Human Services: 

Appendix III: GAO Contacts and Staff Acknowledgments: 

Tables: 

Table 1: Key Privacy Principles in HIPAA's Privacy Rule: 

Table 2: Challenges to Exchanging Electronic Health Information: 

Abbreviations: 

HHS: Department of Health and Human Services: 

HIPAA: Health Insurance Portability and Accountability Act of 1996: 

IT: information technology: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

September 17, 2008: 

The Honorable Daniel K. Akaka: 
Chairman: 
Subcommittee on Oversight of Government Management, the Federal 
Workforce, and the District of Columbia: 
Committee on Homeland Security and Governmental Affairs: 
United States Senate: 

Dear Mr. Chairman: 

Advances in health information technology (IT) have the potential to 
improve the quality of health care, to increase the availability of 
health information for treatment, and to implement safeguards that 
cannot be applied easily or cost-effectively to paper-based health 
records. However, the automation of health information also introduces 
new risks to the privacy of that information. A September 2007 survey 
sponsored by the Institute of Medicine indicated that nearly 60 percent 
of the respondents did not believe that the privacy of personal medical 
records and health information was adequately protected by federal and 
state laws and organization practices.[Footnote 1] According to the 
National Research Council,[Footnote 2] medical information is often the 
most privacy-sensitive information that patients provide to others 
about themselves, and protecting medical privacy has long been 
recognized as an essential element in a health care system. Further, 
industry groups and professional associations have called for stronger 
privacy protection of personal health information. 

In April 2004, President Bush issued an executive order that called for 
the development and implementation of a strategic plan to guide the 
nationwide implementation of interoperable health IT in both the public 
and private sectors.[Footnote 3] The order required the plan to address 
privacy and security issues related to interoperable health IT and 
recommend methods to ensure appropriate authorization, authentication, 
and encryption of data for transmission over the Internet. In 2004, the 
Secretary of Health and Human Services, through the Office of the 
National Coordinator for Health Information Technology, documented a 
framework for health IT as the first step toward the development of a 
national strategy.[Footnote 4] This framework stated that strengthening 
privacy protections for electronic personal health information was a 
critical health care need. 

In January 2007, we reported on activities of the Department of Health 
and Human Services (HHS) and its Office of the National Coordinator for 
Health IT to identify solutions for protecting personal health 
information.[Footnote 5] We noted that HHS was in the early stages of 
these activities and had not yet defined an overall approach for 
addressing key privacy principles and challenges, nor had it defined 
milestones or identified a responsible entity for integrating the 
results of these activities. Consequently, we recommended that the 
Secretary of Health and Human Services define and implement an overall 
approach for protecting health information that would (1) identify 
milestones and the entity responsible for integrating the outcomes of 
its privacy-related initiatives, (2) ensure that key privacy principles 
in the Health Insurance Portability and Accountability Act of 1996 
(HIPAA)[Footnote 6] are fully addressed, and (3) address key challenges 
associated with the nationwide exchange of health information. 
Subsequently, the department's National Coordinator for Health IT 
agreed with the need for an overall approach to protect health 
information and stated that the department was initiating steps to 
address our recommendation. 

As you requested, we conducted a follow-up study of the Office of the 
National Coordinator's efforts to ensure the privacy of electronic 
personal health information exchanged within a nationwide health 
information network. Our objective was to provide an update on the 
department's efforts to define and implement an overall privacy 
approach, as we recommended. 

To address our objective, we analyzed reports and other documentation 
of the Office of the National Coordinator's current health IT 
initiatives related to privacy. We also obtained and analyzed the 
department's documents describing plans and outcomes from the Office of 
the National Coordinator's health IT initiatives related to privacy, 
and we supplemented our analysis with interviews of officials from the 
National Coordinator's office to discuss the department's current 
approaches and future plans for developing and implementing an overall 
approach for addressing privacy protection within a nationwide health 
information network. 

We conducted this performance audit from April 2008 through September 
2008 in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. Our 
objective, scope, and methodology are described in appendix I. 

Results in Brief: 

Since we reported in January 2007 on HHS's efforts to protect 
electronic personal health information, the department has undertaken 
various initiatives that are contributing to its efforts to develop and 
implement an overall privacy approach. We recommended that this 
approach include (1) identifying milestones and the entity responsible 
for integrating the outcomes of its privacy-related initiatives, (2) 
ensuring that key privacy principles in HIPAA are fully addressed, and 
(3) addressing key challenges associated with the nationwide exchange 
of health information. In this regard, the department has fulfilled the 
first part of our recommendation, and it has taken important steps in 
addressing the two other parts. The Office of the National Coordinator 
for Health IT has continued to develop and implement initiatives 
related to a nationwide health information network, and these 
initiatives include activities that are intended to address certain key 
privacy principles and challenges. For example: 

* The Healthcare Information Technology Standards Panel defined 
standards for implementing security features in health IT systems that 
process personal health information. 

* The Certification Commission for Healthcare Information Technology 
defined certification criteria that include privacy protections for 
both outpatient and inpatient electronic health records. 

* State-level initiatives (such as the Health Information Security and 
Privacy Collaboration and the State Alliance for e-Health) have 
convened stakeholders to identify and propose solutions for addressing 
challenges to protecting the privacy of electronic health information 
faced by health information exchange organizations. 

In addition, the Office of the National Coordinator has identified 
milestones and the entity responsible for integrating the outcomes of 
its privacy-related initiatives, as we recommended. Further, the 
Secretary released a federal health IT strategic plan in June 2008 that 
includes privacy and security objectives along with strategies and 
target dates for achieving them. The strategic plan also outlines the 
Office of the National Coordinator's plans for developing a 
confidentiality, privacy, and security framework to incorporate the 
outcomes of privacy-related initiatives, which it expects to publish by 
December 2008. 

Nevertheless, while the aforementioned initiatives are significant to 
addressing privacy issues and challenges, they fall short of fully 
implementing our recommendation. Specifically, HHS has not defined, as 
part of its approach, a process for ensuring that all privacy 
principles and challenges will be fully and adequately addressed. Given 
the large number and variety of activities being undertaken and the 
many federal, state, and private-sector entities contributing to the 
health IT initiatives, it is important that the department and its 
Office of the National Coordinator define a process for ensuring that 
all stakeholders' contributions will be appropriately considered and 
that inputs to the privacy framework will be effectively assessed and 
prioritized to achieve comprehensive coverage of all privacy principles 
and challenges. In the absence of an overall approach that includes 
such a process, HHS faces the risk that privacy protection measures may 
not be consistently and effectively built into health IT programs, thus 
jeopardizing patient privacy as well as the public confidence and trust 
that are essential to the success of a future nationwide health 
information network. 

We are recommending that HHS include in its overall privacy approach a 
process for assessing and prioritizing initiatives and the 
stakeholders' needs to ensure that key privacy principles and 
challenges are completely and adequately addressed. 

HHS's Assistant Secretary for Legislation provided written comments on 
a draft of this report. In the comments, the department generally 
agreed with the information provided in the draft report; however, it 
neither agreed nor disagreed with our recommendation. HHS agreed that 
more work remains to be done in the department's efforts to protect the 
privacy of electronic personal health information and stated that the 
department is actively pursuing a process for assessing and 
prioritizing privacy-related initiatives intended to build public trust 
and confidence in health IT. As we recommended, effective 
implementation of such a process could help ensure that the 
department's overall privacy approach fully addresses key privacy 
principles and challenges. 

Background: 

Recognizing the potential value of IT for public and private health 
systems,[Footnote 7] the federal government has, for several years, 
been working to promote the nationwide use of health IT.[Footnote 8] In 
April 2004, President Bush called for widespread adoption of 
interoperable electronic health records within 10 years and issued an 
executive order[Footnote 9] that established the position of the 
National Coordinator for Health IT within HHS. The National 
Coordinator's responsibilities include developing, maintaining, and 
directing the implementation of a strategic plan to guide the 
nationwide implementation of interoperable health IT in both the public 
and private sectors. According to the strategic plan, the National 
Coordinator is to lead efforts to build a national health IT 
infrastructure that is intended to, among other things, ensure that 
patients' individually identifiable health information[Footnote 10] is 
secure, protected, and available to the patient to be used for medical 
and nonmedical purposes, as directed by the patient and as appropriate. 

In January 2007, we reported on the steps that HHS was taking to ensure 
the protection of personal health information exchanged within a 
nationwide network and on the challenges facing health information 
exchange organizations in protecting electronic personal health 
information.[Footnote 11] We reported that although HHS and the Office 
of the National Coordinator had initiated actions to identify solutions 
for protecting electronic personal health information, the department 
was in the early stages of its efforts and had not yet defined an 
overall privacy approach. As described earlier, we made recommendations 
regarding the need for an overall privacy approach, which we reiterated 
in subsequent testimonies in February 2007, June 2007, and February 
2008.[Footnote 12] 

In our report, we described applicable provisions of HIPAA and other 
federal laws that are intended to protect the privacy of certain health 
information, along with the HIPAA Privacy Rule[Footnote 13] and key 
principles that are reflected in the rule. Table 1 summarizes these 
principles. 

Table 1: Key Privacy Principles in HIPAA's Privacy Rule: 

Principle: Uses and disclosures; 
Description: Provides limits to the circumstances in which an 
individual's protected health information may be used or disclosed by 
covered entities and provides for accounting of certain disclosures; 
requires covered entities to make reasonable efforts to disclose or use 
only the minimum necessary information to accomplish the intended 
purpose for the uses, disclosures, or requests, with certain 
exceptions, such as for treatment or as required by law. 

Principle: Notice; 
Description: Requires most covered entities to provide a notice of 
their privacy practices, including how personal health information may 
be used and disclosed. 

Principle: Access; 
Description: Establishes individuals' right to review and obtain a copy 
of their protected health information held in a designated record 
set.[A] 

Principle: Security[B]; 
Description: Requires covered entities to safeguard protected health 
information from inappropriate use or disclosure. 

Principle: Amendments; 
Description: Gives individuals the right to request from covered 
entities changes to inaccurate or incomplete protected health 
information held in a designated record set.[A] 

Principle: Administrative requirements; 
Description: Requires covered entities to analyze their own needs and 
implement solutions appropriate for their own environment based on a 
basic set of requirements for which they are accountable. 

Principle: Authorization; 
Description: Requires covered entities to obtain the individual's 
written authorization or consent for uses and disclosures of personal 
health information, with certain exceptions, such as for treatment, 
payment, and health care operations, or as required by law. Covered 
entities may choose to obtain the individual's consent to use or 
disclose protected health information to carry out treatment, payment, 
or health care operations but are not required to do so. 

Source: GAO analysis of HIPAA Privacy Rule. 

[A] According to the HIPAA Privacy Rule, a designated record set is a 
group of records maintained by or for a covered entity that is (1) the 
medical records and billing records about individuals maintained by or 
for a covered health care provider; (2) the enrollment, payment, claims 
adjudication, and case or medical management record systems maintained 
by or for a health plan; or (3) used, in whole or in part, by or for 
the covered entity to make decisions about individuals. 

[B] The HIPAA Security Rule further defines safeguards that covered 
entities must implement to provide assurance that health information is 
protected from inappropriate uses and disclosure. 

[End of table] 

We also described in our report and testimonies challenges associated 
with protecting electronic health information that are faced by federal 
and state health information exchange organizations and health care 
providers. These challenges are summarized in table 2. 

Table 2: Challenges to Exchanging Electronic Health Information: 

Challenge: Understanding and resolving legal and policy issues; 
Description: 
* Resolving uncertainties regarding varying the extent of federal 
privacy protection required of various organizations; 
* Understanding and resolving data-sharing issues introduced by varying 
state privacy laws and organization-level practices; 
* Reaching agreement on organizations' differing interpretations and 
applications of HIPAA privacy and security rules; 
* Determining liability and enforcing sanctions in cases of breach of 
confidentiality. 

Challenge: Ensuring appropriate disclosure; 
Description: 
* Determining the minimum data necessary that can be disclosed in order 
for requesters to accomplish their intended purposes; 
* Obtaining individuals' authorization and consent for use and 
disclosure of personal health information; 
* Determining the best way to allow individuals to participate in and 
consent to electronic health information exchange; 
* Educating consumers so that they understand the extent to which their 
consent to use and disclose health information applies. 

Challenge: Ensuring individuals' rights to request access and 
amendments to health information to ensure it is correct; 
Description: 
* Ensuring that individuals understand that they have rights to request 
access and amendments to their own health information to ensure that it 
is correct; 
* Ensuring that individuals' amendments are properly made and tracked 
across multiple locations. 

Challenge: Implementing adequate security measures for protecting 
health information; 
Description: 
* Determining and implementing adequate techniques for authenticating 
requesters of health information; 
* Implementing proper access controls and maintaining adequate audit 
trails for monitoring access to health data; 
* Protecting data stored on portable devices and transmitted between 
business partners. 

Source: GAO analysis of information provided by state-level health 
information exchange organizations, federal health care providers, and 
health IT professional associations. 

[End of table] 

We reported that HHS had undertaken several initiatives intended to 
address aspects of key principles and challenges for protecting the 
privacy of health information. For example, in 2005, the department 
awarded four health IT contracts that included requirements for 
developing solutions to comply with federal privacy requirements and 
identifying techniques and standards for securing health information. 

HHS Has Taken Steps to Address Privacy Principles and Challenges, but 
It Has Not Fully Implemented an Overall Privacy Approach: 

Since January 2007, HHS has undertaken various initiatives that are 
contributing to its development of an overall privacy approach, 
although more work remains. We recommended that this overall approach 
include (1) identifying milestones and the entity responsible for 
integrating the outcomes of its privacy-related initiatives, (2) 
ensuring that key privacy principles in HIPAA are fully addressed, and 
(3) addressing key challenges associated with the nationwide exchange 
of health information. In this regard, the department has fulfilled the 
first part of our recommendation, and it has taken important steps in 
addressing the two other parts. Nevertheless, these steps have fallen 
short of fully implementing our recommendation because they do not 
include a process for ensuring that all key privacy principles and 
challenges will be fully and adequately addressed. In the absence of 
such a process, HHS may not be effectively positioned to ensure that 
health IT initiatives achieve comprehensive privacy protection within a 
nationwide health information network. 

HHS Has Taken Steps to Address Privacy Principles and Challenges 
through Its Various Health IT Initiatives: 

The department and its Office of the National Coordinator have 
continued taking steps intended to address key privacy principles and 
challenges through various health IT initiatives. Among other things, 
these initiatives have resulted in technical requirements, standards, 
and certification criteria related to the key privacy principles 
described in table 1. The following are examples of ways that the 
Office of the National Coordinator's health IT initiatives relate to 
privacy principles reflected in HIPAA. 

* As part of its efforts to advance health IT, the American Health 
Information Community[Footnote 14] defines "use cases," which are 
descriptions of specific business processes and ways that systems 
should interact with users and with other systems to achieve specific 
goals. Among other things, several of the use cases include 
requirements and specifications that address aspects of the access, 
uses and disclosures, and amendments privacy principles. For example, 
the "consumer empowerment" use case describes at a high level specific 
capabilities that align with the access principle. It requires that 
health IT systems include mechanisms that allow consumers to access 
their own clinical information, such as lab results and diagnosis 
codes, from other sources to include in their personal health records. 
The use case also aligns with the uses and disclosures principle and 
includes requirements that allow consumers to control access to their 
personal health record information and specify which information can be 
accessed by health care providers and organizations within health 
information networks. Further, the consumer empowerment use case aligns 
with the amendments privacy principle, emphasizing the need for 
policies to guide decisions about which data consumers should be able 
to modify, annotate, or request that organizations change. (Other use 
cases that are related to these privacy principles are the 
"personalized healthcare"[Footnote 15] and "remote monitoring"[Footnote 
16] use cases.) 

* Under HHS's initiative to implement a nationwide health information 
network,[Footnote 17] in January 2007, four test network 
implementations, or prototypes, demonstrated potential nationwide 
health information exchange and laid the foundation for the Office of 
the National Coordinator's ongoing network trial implementations. 
Activities within the prototypes and the trial implementations are 
related to privacy principles, including the security, access, uses and 
disclosures, and administrative requirements principles. For example, 
the prototypes produced specific requirements for security mechanisms 
(such as data access control and encryption) that address aspects of 
the security principle. Additionally, the ongoing trial implementations 
are guided by requirements for using personal health data intended to 
address the access, uses and disclosures, and administrative 
requirements principles. For example, participants in the trial 
implementations are to provide the capability for consumers to access 
information, such as registration and medication history data, from 
other sources to include in their personal health records, to control 
access to self-entered data or clinical information held in a personal 
health record, and to control the types of information that can be 
released from personal health records for health information exchange. 
In addition, organizations participating in the network are required to 
provide system administrators the ability to monitor and audit all 
access to and use of the data stored in their systems. 

* The Healthcare Information Technology Standards Panel continued work 
to "harmonize" standards directly related to several key privacy 
principles, primarily the security principle.[Footnote 18] In addition, 
the panel developed technical guidelines that are intended to address 
other privacy principles, such as the authorization principle and the 
uses and disclosures principle. For example, the panel's guidelines 
specify that systems should be designed to ensure that consumers' 
instructions related to authorization and consent are captured, 
managed, and available to those requesting the health information. 

* The Certification Commission for Healthcare Information Technology, 
which is developing and evaluating the criteria and process for 
certifying the functionality, security, and interoperability of 
electronic health records, took steps that primarily address the 
security principle. For example, the commission defined specific 
security criteria for both ambulatory and inpatient electronic health 
records that require various safeguards to be in place before 
electronic health record systems are certified. Among other things, 
these safeguards include ensuring that system administrators can modify 
the privileges of users so that only those who have a need to access 
patients' information are allowed to do so and that the minimum amount 
of information necessary can be accessed by system users. 

* The State-Level Health Information Exchange Consensus Project, a 
consortium of public and private-sector stakeholders, is intended to 
promote consistent organizational policies regarding privacy and health 
information exchange. The consortium issued a report in February 2007 
that addresses, among other principles, the uses and disclosures 
privacy principle. For example, the report advises health information 
exchange organizations to maintain information about access to and 
disclosure of patients' personal health information and to make that 
data available to patients. The consortium subsequently issued another 
report in March 2008 that recommended practices to ensure the 
appropriate access, use, and control of health information. 

Additionally, two of HHS's key advisory groups continued to develop and 
provide recommendations to the Secretary of HHS for addressing privacy 
issues and concerns: 

* The Confidentiality, Privacy, and Security Workgroup was formed in 
2006 by the American Health Information Community to focus specifically 
on these issues and has submitted recommendations to the community that 
address privacy principles. Among these are recommendations related to 
the notice principle that the workgroup submitted in February and April 
2008. These recommendations stated that health information exchange 
organizations should provide patients, via the Web or another means, 
information in plain language on how these organizations use and 
disclose health information, their privacy policies and practices, and 
how they safeguard patient or consumer information. The work group also 
submitted recommendations related to the administrative requirements 
principle, stating that the obligation to provide individual rights and 
a notice of privacy practices under HIPAA should remain with the health 
care provider or plan that has an established, independent relationship 
with a patient, not with the health information exchange. 

* The National Committee on Vital and Health Statistics, established in 
1949, advises the Secretary of HHS on issues including the 
implementation of health IT standards and safeguards for protecting the 
privacy of personal health information.[Footnote 19] The committee's 
recent recommendations related to HHS's health IT initiatives 
addressed, among others, the uses and disclosures principle. For 
example, in February 2008, the National Committee submitted five 
recommendations to the Secretary that support an individual's right to 
control the disclosure of certain sensitive health information for the 
purposes of treatment. 

Although the recommendations from these two advisory groups are still 
under consideration by the Secretary, according to HHS officials, 
contracts for the nationwide health information network require 
participants to consider these recommendations when conducting network 
trials once they are accepted by the Secretary. 

The Office of the National Coordinator also took actions intended to 
address key challenges to protecting exchanges of personal electronic 
health information. Specifically, state-level initiatives (described 
below) were formed to bring stakeholders from states together to 
collaborate, propose solutions, and make recommendations to state and 
federal policymakers for addressing challenges to protecting the 
privacy of electronic personal health information within a nationwide 
health information exchange. Outcomes of these initiatives provided 
specific state-based solutions and recommendations for federal policy 
and guidance for addressing key challenges described by our prior work 
(see table 2).[Footnote 20] 

* The Health Information Security and Privacy Collaboration is pursuing 
privacy and security projects directly related to several of the 
privacy challenges identified in our prior work, including the need to 
resolve legal and policy issues resulting from varying state laws and 
organizational-level business practices and policies, and the need to 
obtain individuals' consent for the use and disclosure of personal 
health information. For example, the state teams noted the need for 
clarification about how to interpret and apply the "minimum necessary" 
standard, and they recommended that HHS provide additional guidance to 
clarify this issue. In addition, most of the state teams cited the need 
for a process to obtain patient permission to use and disclose personal 
health information, and the teams identified multiple solutions to 
address differing definitions of patient permission, including the 
creation of a common or uniform permission form for both paper and 
electronic environments. 

* The State Alliance for e-Health created an information protection 
task force that in August 2007 proposed five recommendations that are 
intended to address the challenge of understanding and resolving legal 
and policy issues. The recommendations, which the alliance accepted, 
focused on methods to facilitate greater state-federal interaction 
related to protecting privacy and developing common solutions for the 
exchange of electronic health information. 

Beyond the initiatives previously discussed, in June 2008, the 
Secretary released a federal health IT strategic plan[Footnote 21] that 
includes a privacy and security objective for each of its strategic 
goals, along with strategies and target dates for achieving the 
objectives. [Footnote 22] For example, one of the strategies is to 
complete the development of a confidentiality, privacy, and security 
framework by the end of 2008, and another is to address inconsistent 
statutes or regulations for the exchange of electronic health 
information by the end of 2011. The strategic plan emphasized the 
importance of privacy protection for electronic personal health 
information by acknowledging that the success of a nationwide, 
interoperable health IT infrastructure in the United States will 
require a high degree of public confidence and trust. 

In accordance with this strategy, the Office of the National 
Coordinator is responsible for developing the confidentiality, privacy, 
and security framework. The National Coordinator has indicated that 
this framework, which is to be developed and published by the end of 
calendar year 2008,[Footnote 23] is to incorporate the outcomes of the 
department's privacy-related initiatives, and that milestones have been 
developed and responsibility assigned for integrating these outcomes. 
The National Coordinator has assigned responsibility for these 
integration efforts and the development of the framework to the 
Director of the Office of Policy and Research within the Office of the 
National Coordinator. In this regard, the department has fulfilled the 
first part of our recommendation. 

Steps Taken Have Not Fully Implemented an Overall Privacy Approach: 

While the various initiatives that HHS has undertaken are contributing 
to the development and implementation of an overall privacy approach, 
more work remains. In particular, the department has not defined a 
process for ensuring that all privacy principles and challenges will be 
fully and adequately addressed. This process would include, for 
example, steps for ensuring that all stakeholders' contributions to 
defining privacy-related activities are appropriately considered and 
that individual inputs to the privacy framework will be effectively 
assessed and prioritized to achieve comprehensive coverage of all key 
privacy principles and challenges. 

Such a process is important given the large number and variety of 
activities being undertaken and the many stakeholders contributing to 
the health IT initiatives. In particular, the contributing activities 
involve a wide variety of stakeholders, including federal, state and 
private-sector entities. Further, certain privacy-related activities 
are relevant only to specific principles or challenges, and are 
generally not aimed at comprehensively addressing all privacy 
principles and challenges. For example, the certification and standards 
harmonization efforts primarily address the implementation of technical 
solutions for interoperable health IT and, therefore, are aimed at 
system-level security measures, such as data encryption and password 
protections, while the recommendations submitted by HHS's advisory 
committees and state-level initiatives are primarily aimed at policy 
and legal issues. Effectively assessing the contributions of individual 
activities could play an important role in determining how each 
activity contributes to the collective goal of ensuring comprehensive 
privacy protection. Additionally, the outcomes of the various 
activities may address privacy principles and challenges to varying 
degrees. For example, while a number of the activities address the uses 
and disclosures principle, HHS's advisory committees have made 
recommendations that the department's activities more extensively 
address the notice principle. Consequently, without defined steps for 
thoroughly assessing the contributions of the activities, some 
principles and challenges may be addressed extensively, while others 
may receive inadequate attention, leading to gaps in the coverage of 
the principles and challenges. 

In discussing this matter with us, officials in the Office of the 
National Coordinator pointed to the various health IT initiatives as an 
approach that it is taking to manage privacy-related activities in a 
coordinated and integrated manner. For example, the officials stated 
that the purpose of the American Health Information Community's use 
cases is to provide guidance and establish requirements for privacy 
protections that are intended to be implemented throughout the 
department's health IT initiatives (including standards harmonization, 
electronic health records certification, and the nationwide health 
information network). Similarly, contracts for the nationwide health 
information network require participants to adopt approved health IT 
standards (defined by the Healthcare Information Technology Standards 
Panel) and, as mentioned earlier, to consider recommendations from the 
American Health Information Community and the National Committee on 
Vital and Health Statistics when conducting network trials, once these 
recommendations are accepted or adopted by the Secretary. 

While these are important activities for addressing privacy, they do 
not constitute a defined process for assessing and prioritizing the 
many privacy-related initiatives and the needs of stakeholders to 
ensure that privacy issues and challenges will be addressed fully and 
adequately. Without a process that accomplishes this, HHS faces the 
risk that privacy protection measures may not be consistently and 
effectively built into health IT programs, thus jeopardizing patient 
privacy as well as the public confidence and trust that are essential 
to the success of a future nationwide health information network. 

Conclusions: 

HHS and its Office of the National Coordinator for Health IT intend to 
address key privacy principles and challenges through integrating the 
privacy-related outcomes of the department's health IT initiatives. 
Although it has established milestones and assigned responsibility for 
integrating these outcomes and for the development of a 
confidentiality, privacy, and security framework, the department has 
not fully implemented our recommendation for an overall privacy 
approach that is essential to ensuring that privacy principles and 
challenges are fully and adequately addressed. Unless HHS's privacy 
approach includes a defined process for assessing and prioritizing the 
many privacy-related initiatives, the department may not be able to 
ensure that key privacy principles and challenges will be fully and 
adequately addressed. Further, stakeholders may lack the overall 
policies and guidance needed to assist them in their efforts to ensure 
that privacy protection measures are consistently built into health IT 
programs and applications. As a result, the department may miss an 
opportunity to establish the high degree of public confidence and trust 
needed to help ensure the success of a nationwide health information 
network. 

Recommendation for Executive Action: 

To ensure that key privacy principles and challenges are fully and 
adequately addressed, we recommend that the Secretary of Health and 
Human Services direct the National Coordinator for Health IT to include 
in the department's overall privacy approach a process for assessing 
and prioritizing its many privacy-related initiatives and the needs of 
stakeholders. 

Agency Comments and Our Evaluation: 

HHS's Assistant Secretary for Legislation provided written comments on 
a draft of this report. In the comments, the department generally 
agreed with the information discussed in our report; however, it 
neither agreed nor disagreed with our recommendation. 

HHS agreed that more work remains to be done in the department's 
efforts to protect the privacy of electronic personal health 
information and stated that it is actively pursuing a two-phased 
process for assessing and prioritizing privacy-related initiatives 
intended to build public trust and confidence in health IT, 
particularly in electronic health information exchange. According to 
HHS, the process will include work with stakeholders to ensure that 
real-world privacy challenges are understood. In addition, the 
department stated that the process will assess the results and 
recommendations from the various health IT initiatives and measure 
progress toward addressing privacy-related milestones established by 
the health IT strategic plan. As we recommended, effective 
implementation of such a process could help ensure that the 
department's overall privacy approach fully addresses key privacy 
principles and challenges. 

HHS also provided technical comments, which we have incorporated into 
the report as appropriate. The department's written comments are 
reproduced in appendix II. 

We are sending copies of this report to interested congressional 
committees and to the Secretary of HHS. Copies of this report will be 
made available at no charge on our Web site at [hyperlink, 
http://www.gao.gov]. 

If you have any questions on matters discussed in this report, please 
contact me at (202) 512-6304 or Linda Koontz at (202) 512-6240, or by e-
mail at [email protected] or [email protected]. Contact points for our 
offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. Other contacts and key contributors to 
this report are listed in appendix III. 

Sincerely yours, 

Signed by: 

Valerie C. Melvin: 
Director, Human Capital and Management Information Systems Issues: 

Signed by: 

Linda D. Koontz: 
Director, Information Management Issues: 

[End of section] 

Appendix I: Objective, Scope, and Methodology: 

Our objective was to provide an update on the department's efforts to 
define and implement an overall privacy approach, as we recommended in 
an earlier report.[Footnote 24] Specifically, we recommended that the 
Secretary of Health and Human Services define and implement an overall 
approach for protecting health information that would (1) identify 
milestones and the entity responsible for integrating the outcomes of 
its privacy-related initiatives, (2) ensure that key privacy principles 
in the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) are fully addressed, and (3) address key challenges associated 
with the nationwide exchange of health information. 

To determine the status of HHS's efforts to develop an overall privacy 
approach, we analyzed the department's federal health IT strategic plan 
and documents related to its planned confidentiality, privacy, and 
security framework. We also analyzed plans and documents that described 
activities of each of the health IT initiatives under the Office of the 
National Coordinator and identified those intended to (1) develop and 
implement mechanisms for addressing privacy principles and (2) develop 
recommendations for overcoming challenges to ensuring the privacy of 
patients' information. Specifically, we assessed descriptions of the 
intended outcomes of the office's health IT initiatives to determine 
the extent to which they related to these privacy principles and 
challenges identified by our prior work. 

To supplement our data collection and analysis, we conducted interviews 
with officials from the Office of the National Coordinator to discuss 
the department's approaches and future plans for addressing the 
protection of personal health information within a nationwide health 
information network. 

We conducted this performance audit at the Department of Health and 
Human Services in Washington, D.C., from April 2008 through September 
2008, in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

September 11, 2008: 

Valerie C. Melvin: 
Director, Human Capital and Management Information Systems: 
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 

Dear Ms. Melvin: 

Enclosed are comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Health Information Technology: HHS Has Taken 
Important Steps to Address Privacy Principles and Challenges, Although 
More Work Remains" (GAO 08-1138). 

The Department appreciates the opportunity to review this report before 
its publication. 

Sincerely, 

Signed by: 

Jennifer R. Luong, for: 
Vincent J. Ventimiglia, Jr. 
Assistant Secretary for Legislation: 

Attachment: 

Comments Of The Department Of Health And Human Services (HHS) On The 
U.S. Government Accountability Office's (GAO) Draft Report Entitled: 
Health Information Technology - HHS Has Taken Important Steps To 
Address Privacy Principles And Challenges, Although More Work Remains 
(GAO 08-1138): 

General Comments: 

The Department of Health and Human Services (HHS) appreciates the 
opportunity to review the Government Accountability Office's (GAO) 
draft report entitled "Health Information Technology - HHS Has Taken 
Important Steps to Address Privacy Principles and Challenges, Although 
More Work Remains." 

In this update to the GAO's previous report on this subject, we 
appreciate the GAO's recognition that "HHS has taken important steps to 
address privacy principles and challenges" related to health 
information technology (health IT). We agree that more work remains. 

Progress is being made toward the President's goal that most Americans 
have secure electronic health records by 2014. HHS will continue to 
address privacy and security from both a technology and policy 
perspective as we advance a nationwide, interoperable health IT 
infrastructure that has sufficient flexibility to be able to 
incorporate privacy and security solutions as they are developed. 

The GAO correctly identifies many ongoing HHS initiatives that address 
privacy and security. It is important to note that the report lists 
representative examples of HHS initiatives in this area, and is not 
intended to provide a complete compilation of HHS's privacy and 
security activities. 

In June 2008, HHS published the ONC-Coordinated Federal Health IT 
Strategic Plan: 2008-2012 (the Strategic Plan), which includes several 
specific strategies to address privacy and security of personal health 
information in health IT initiatives. The key concept of coordination 
reflected in the Strategic Plan's title is an essential component of 
all our privacy and security strategies. While HHS is a leader in 
health care and health IT, we recognize that our mission cannot be 
accomplished without coordination and input from a wide range of 
stakeholders. To that end, HHS has joined with state and other Federal 
agencies, as well as the private sector, to engage a variety of 
stakeholders in our health IT initiatives. Some examples of HHS's 
privacy and security initiatives and activities include the Healthcare 
Information Technology Standards Panel, the Certification Commission 
for Healthcare Information Technology, the Health Information Security 
and Privacy Collaboration, the State Alliance for e-Health, the State-
level Health Information Exchange Consensus Project, the Nationwide 
Health Information Network Trial Implementations, the American Health 
Information Community, and the National Committee on Vital and Health 
Statistics. Thousands of participants are engaged in these efforts. 

HHS is actively pursuing a two-stage process for assessing and 
prioritizing privacy and security-related initiatives to build public 
trust and confidence in health IT and in particular electronic health 
information exchange. This process reflects our role as coordinators 
and our belief that public-private dialogue is necessary to inform next 
steps and achieve trust. First, we work with stakeholders to understand 
concerns and real-world privacy and security challenges. Second, we 
address privacy principles and challenges by assessing results and 
recommendations from our initiatives, evaluating how each activity 
builds on or influences the others, and measuring progress toward the 
milestones established in the Strategic Plan. The process has and will 
continue to address key privacy principles and challenges, develop 
policies and guidance needed by stakeholders, and build a nationwide, 
interoperable health IT infrastructure that includes the privacy and 
security protections needed to ensure public confidence and trust. 

HHS initiatives will continue to assure that electronic health 
information is private and secure while concurrently improving 
individual and population health through the advancement and adoption 
of interoperable health IT. 

[End of section] 

Appendix III: GAO Contacts and Staff Acknowledgments: 

GAO Contacts: 

Valerie C. Melvin, (202) 512-6304 or [email protected] Linda D. Koontz, 
(202) 512-6240 or [email protected]: 

Acknowledgments: 

In addition to those named above, key contributors to this report were 
John A. de Ferrari, Assistant Director; Teresa F. Tucker, Assistant 
Director; Barbara Collier; Heather A. Collins; Susan S. Czachor; Amanda 
C. Gill; Nancy Glover; M. Saad Khan; Thomas E. Murphy; and Sylvia L. 
Shanks. 

[End of section] 

Footnotes: 

[1] Institute of Medicine, How the Public Views Privacy and Health 
Research (Washington, D.C.: November 2007). 

[2] The National Research Council is sponsored by the National Academy 
of Sciences, the National Academy of Engineering, and the Institute of 
Medicine. The mission of the council is to improve government decision 
making and public policy, increase public education and understanding, 
and promote the acquisition and dissemination of knowledge in matters 
involving science, engineering, technology, and health. 

[3] Executive Order 13335, Incentives for the Use of Health Information 
Technology and Establishing the Position of the National Health 
Information Technology Coordinator (Washington, D.C.: Apr. 27, 2004). 

[4] Department of Health and Human Services, The Decade of Health 
Information Technology: Delivering Consumer-centric and Information- 
rich Health Care--Framework for Strategic Action (Washington, D.C.: 
July 21, 2004). 

[5] GAO, Health Information Technology: Early Efforts Initiated but 
Comprehensive Privacy Approach Needed for National Strategy, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-238] (Washington, 
D.C.: Jan. 10, 2007). 

[6] The act provided for the Secretary of HHS to establish the first 
broadly applicable federal privacy and security protections designed to 
protect individually identifiable health information. Pub. L. No. 104- 
191 (Aug. 21, 1996), sec. 262(a); 42 U.S.C. 1320d-2. Throughout this 
report, when we refer to key privacy principles in HIPAA, we are 
referring to the privacy principles promulgated under HIPAA's 
Administrative Simplification provisions. 

[7] The nation's public health system is made up of the federal, state, 
tribal, and local agencies that deliver health care services to and 
monitor the health of the population. Private health system 
participants include hospitals, physicians, pharmacies, nursing homes, 
and other organizations that deliver health care services to individual 
patients. 

[8] Health IT is the use of technology to electronically collect, 
store, retrieve, and transfer clinical, administrative, and financial 
health information. 

[9] Executive Order 13335, April 27, 2004. 

[10] Individually identifiable health information is the term used in 
the Health Insurance Portability and Accountability Act of 1996 to 
describe "personal health information" as defined in this report. 

[11] [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-238. 

[12] GAO, Health Information Technology: Early Efforts Initiated, but 
Comprehensive Privacy Approach Needed for National Strategy, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-400T] (Washington, 
D.C.: Feb. 1, 2007); Health Information Technology: Efforts Continue 
but Comprehensive Privacy Approach Needed for National Strategy, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-988T] (Washington, 
D.C.: June 19, 2007); Health Information Technology: HHS Is Pursuing 
Efforts to Advance Nationwide Implementation, but Has Not Yet Completed 
a National Strategy, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-
08-499T] (Washington, D.C.: Feb. 14, 2008). 

[13] The Secretary of HHS issued HIPAA's Privacy Rule in December 2000, 
and, after modification, in August 2002. The Privacy Rule governs the 
use and disclosure of individually identifiable health information 
that, with some exceptions, is held or transmitted in any form or 
medium by a covered entity. 

[14] The community is a federal advisory body set up to make 
recommendations on how to accelerate the development and adoption of 
health IT, including identifying health IT standards, advancing 
nationwide health information exchange, and protecting personal health 
information. 

[15] The personalized healthcare use case focuses on the exchange of 
genetic/genomic test information, personal and family health history, 
and the use of analytical tools in electronic health records to support 
clinical decision making. 

[16] Remote monitoring refers to the ability to monitor patient 
information--such as physiological, diagnostic, medication tracking, 
and activities of daily living measurements--using the patient's 
electronic or personal health record. 

[17] HHS's nationwide health information network initiative is managed 
by the Office of National Coordinator for Health IT. Building on the 
results of its earlier prototypes, HHS awarded contracts to nine health 
information exchange organizations and cooperative agreements to six 
additional organizations to develop trial implementations for testing 
real-time information exchange and interoperability (that is, the 
ability of two or more systems or components to exchange information 
and to use the information that has been exchanged). The Social 
Security Administration, the Departments of Defense and Veterans 
Affairs, and HHS's Indian Health Services are also participating in 
these trials. 

[18] "Harmonizing" is the process of identifying overlaps and gaps in 
relevant standards and developing recommendations to address these 
overlaps and gaps. 

[19] The National Committee on Vital and Health Statistics was 
established as a public advisory committee that is statutorily 
authorized to advise the Secretary of HHS on health data, statistics, 
and national health information policy, including the implementation of 
health IT standards. 

[20] A third state-level initiative, the State-Level Health Information 
Exchange Consensus Project (described earlier), issued a report in 
March 2008 that also discusses internal challenges facing state health 
IT organizations, such as organizational structure and resource 
sustainability. 

[21] HHS, Office of the National Coordinator for Health Information 
Technology, The ONC-Coordinated Federal Health IT Strategic Plan: 2008- 
2012 (Washington, D.C.: June 3, 2008). 

[22] The two goals defined in the strategic plan are to (1) enable the 
transformation to higher quality, more efficient, patient-focused 
health care through electronic health information access and use by 
care providers and by patients and their designees; and (2) enable the 
appropriate, authorized, and timely access and use of electronic health 
information to benefit public health, biomedical research, quality 
improvement, and emergency preparedness. 

[23] The outcomes of these initiatives are also to be integrated into 
the development of the nationwide health information network. 

[24] GAO, Health Information Technology: Early Efforts Initiated but 
Comprehensive Privacy Approach Needed for National Strategy, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-238] (Washington, 
D.C.: Jan. 10, 2007). 

[End of section] 

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