Evaluating Meaningful Use of Health Information Systems

Kathy Johnson, R.N., M.S., Project HealthDesign Ph.D. Candidate in Nursing, University of Wisconsin-Madison

Right now, we are witnessing the birth of a health information technology system architecture. Because of the complexity of this integrated structure, the evaluation of this process requires a great deal of thought.

The Health Information Technology Policy Committee (HITPC) recently solicited public comments on proposed meaningful use Stage 2 criteria [pdf]. May and colleagues’ Normalization Process Model provides theoretical guidance for this type of evaluation (May, et al., 2007). This model proposes that the evaluation of complex intervention implementations requires more than the measurement of outcomes and effectiveness; it holds that the social relations and processes related to the work that leads to those outcomes must also be considered. It emphasizes the processes by which complex interventions are made workable and integrated into everyday practice.

I argue that there is an implicit normativity, or reliance on common perceptions, in the emerging structures of the health information technology system. The proposed criteria for clinician meaningful use reflect only the clinical side of a system that is meant to be used by everyone. This approach to meaningful use is clinician-centric; the opportunity for patients to contribute health information in a format that is meaningful to them has not been addressed. Furthermore, efforts to evaluate the effectiveness of these systems have only been in terms of percentages of information bins filled; the only “meaning” in this rubric is the completion of a task.

Others may assert that there is nothing wrong with an implicit normativity by arguing that the professional is “in charge” of the patient and that the root purpose of the system is the provision of patient-centered care. If that is the case, then we are not moving toward a system that invites patients to participate in their care. Instead we are merely moving from paper to electronic documentation. Before us is a stellar and unprecedented opportunity to create a system that is meaningful for all.

Related resource:

• May, C., Finch, T., Mair, F., Ballini, L., Dowrick, C., Eccles, M., . . . Heaven, B. (2007). Understanding the implementation of complex interventions in health care: The normalization process model. BMC Health Services Research, 7, 148. doi:10.1186/1472-6963-7-148

Can Meaningful Use Become More Meaningful for Patients?

Patricia Flatley Brennan, R.N., Ph.D., Project HealthDesign Director

Because so many of the Stage 1 meaningful use criteria apply primarily to professionals’ uses of health information technology (HIT) in clinical care settings, Project HealthDesign is pleased to see criteria proposed in Stage 2 that would allow patients to become beneficiaries of meaningful use of HIT.

Meaningful use shouldn’t focus exclusively on electronic health records (EHRs) and clinical care settings. It’s time to ensure that the benefits of HIT meaningful use extend to the everyday lives of patients and families.

We call for accelerating the criteria for meaningful use Stage 2 that would lead HIT to:

1. Exchange health data back and forth between EHRs, which house clinically originated data, and PHRs, which house patient-originated data. Health data arise from a variety of sources. Our work on Project HealthDesign has shown that patients value health data that they themselves define and generate. These types of health data, or observations of daily living (ODLs), can include data related to mood, pain levels and even sleep quality.
   
   
2. Allow patients to invite trusted others, including family members, friends and surrogate decision-makers, to access selected health data. The coordination of patient care would benefit from this type of shared access, which engages patients, clinicians and other individuals designated by the patient while also allowing each patient to maintain the level of privacy he or she desires.

Now is the time for a broader, bolder approach to meaningful use. Patients are relying on HIT professionals to ensure that the bilateral exchange of health data between EHRs and PHRs is meaningful for both patients and clinicians. For more information, please read the full Project HealthDesign Stage 2 meaningful use comments.

Related resources:

• View the full draft of proposed Stage 2 meaningful use criteria [pdf].
• Read Project HealthDesign national advisory committee member John Halamka’s comments.

Stakeholders Weigh in on PCAST Report

Deven McGraw, Health Privacy Project Director, Center for Democracy & Technology

Project HealthDesign Director Patti Brennan recently blogged about the report issued by the President’s Council of Advisors on Science and Technology (PCAST), which set forth recommendations to facilitate more effective use of technology for health information exchange. In the post, she praised the more expansive vision of exchange promoted by PCAST and noted the absence of a robust discussion on the need to include patient-generated data as part of this broad vision.

Efforts to analyze the PCAST report and determine how its vision of greater health data liquidity can be achieved have begun in earnest. The Health IT Policy Committee (HITPC) has established a PCAST Report Workgroup, which held a day-long public hearing on Feb. 15.

Stakeholder groups testifying included consumers and patients, providers, technology experts, and health information exchanges. Nearly all agreed with the goal of facilitating more widespread electronic exchange of health data for treatment and secondary data uses like public health and research. But stakeholders also raised a number of concerns about some of the recommendations in the report, including:

• fears that exchange of information at an “atomic data element” level would rob the information of the context necessary for providers and researchers to understand it;
• concerns that providing patients with very granular choices about how their data is shared could be difficult for patients and providers to manage;
• uncertainty about whether the PCAST recommendation for a “universal exchange language” would disrupt (or build on) existing data standardization efforts; and
• questions about whether the designated approach to protecting privacy – tagging data elements with meta data about privacy preferences and other applicable data sharing constraints – would be workable and effective.

The key task for the PCAST Workgroup, the federal advisory committees, and ultimately HHS will be to find a path forward to promote the PCAST vision in a way that builds on work that has been done in the past and effectively responds to implementation concerns raised by stakeholders. Here are a few possibilities:

• Ramp up the requirements for health information exchange in Stages 2 and 3 of meaningful use, including active exchange of data with patients.
• Adopt and implement standards that will allow patients and providers to exchange computable data with one another no matter which EHR, PHR or software application is being used.
• Develop the infrastructure for a query-response model of health data exchange that is based on the needs of the patient.
• Pilot privacy-enhancing technologies (including but not limited to the meta data tagging approach recommended by PCAST) and research both their efficacy and impact on care.

This first year of the meaningful use program provides us with an opportunity to test the efficacy of current strategies for effective use of health IT to improve health and health care. The PCAST Report provides yet another opportunity to consider whether these efforts are headed in the right direction and how we can accelerate progress toward the goals we share.

This week, those interested in HIT have another opportunity to influence future public policy in this arena: HITPC is soliciting public comments on proposed Meaningful Use Stage 2 objectives through Friday, Feb. 25.

Could 2011 Be a Big Year for Consumer Privacy?

Deven McGraw, Health Privacy Project Director, Center for Democracy & Technology

A number of developments at the end of 2010 suggest that 2011 could be an important year in the advancement of consumer personal information protections, which would include health information protections.

• The Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) hosted a day-long roundtable, “Personal Health Records – Understanding the Evolving Landscape,” on December 3, 2010. The roundtable explored the current state and evolving nature of personal health records (PHRs), the value of PHRs to consumers, and privacy and security protections for PHRs.
  
  Three Project HealthDesign principal investigators submitted to the ONC comments demonstrating that a lack of comprehensive protections on PHR data, uncertain application of the law and failure of current law to keep up with technological innovation all hinder progress toward innovative care approaches that leverage innovations in information technology. This testimony will inform a congressionally mandated report on privacy and security protections for entities not covered by HIPAA (which includes many PHRs); this HHS PHR report is expected to be issued in 2011.

• Two days before the PHR Roundtable, the Federal Trade Commission (FTC) issued a comprehensive report on consumer privacy, “Protecting Consumer Privacy in an Era of Rapid Change.” The report was based in part on a series of public roundtables the FTC hosted in 2009 and 2010. In the report, the FTC notes the growing collection of consumer personal data (particularly on the Internet), consumers’ limited understanding of data collection practices and inability to make meaningful choices about them, the importance of privacy to consumers, the significant benefits that result from the increased flow of consumer data, and the blurring distinction online between personally identifiable information and information purported to be “anonymous” or de-identified.
  
  In response, they proposed a new framework for addressing the use of consumer data, both online and offline. This framework has three main components:
  1. Businesses should embrace a full complement of fair information practices and build consumer privacy protections into their everyday business practices (also known as “privacy by design”).
  2. Consumers should have more simplified, streamlined choices about how their data is accessed, used and disclosed.
  3. Businesses should increase the transparency of their data practices.

          The FTC is accepting comments on this report until February 18, 2011.

• Two weeks after the FTC released its consumer privacy report, the U.S. Department of Commerce (DoC) released its own report, “Commercial Data Privacy and Innovation in the Internet Economy: A Dynamic Policy Framework.” This report calls for the U.S. to improve its privacy protection framework and better align itself with global data protection initiatives. DoC also calls for a framework based on a full set of fair information practice principles. Those principles would then be used to create industry-specific codes of conduct that would be developed through negotiations with multiple stakeholders.
  
  The report recommends that any new commercial data privacy framework not conflict with existing laws that provide important protections, such as laws governing the health industry and the financial sector. The report also called for “nationally consistent” security breach notification laws.
  
  DoC is accepting comments on this report until January 28, 2011. Submit comments via e-mail.

At a minimum, these reports indicate a renewed federal focus on privacy protections for consumer data. The reports also suggest that privacy initiatives could garner congressional attention, and that the private sector could also become more engaged in developing strong, voluntary codes of conduct. All of this activity is occurring just as the HITECH meaningful use incentive program begins in earnest, ensuring that a focus on the use and protection of personal health data will remain front and center in 2011.

PCAST Report Comment: Looking Toward Truly Patient-Centered Health Data

Patricia Flatley Brennan, R.N., Ph.D., Project HealthDesign Director

As director of the RWJF-funded Project HealthDesign initiative, I commend the President’s Council of Advisors on Science and Technology (PCAST) for the effort and care evident throughout their December 2010 report, "Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward," and for the attention given to patients and their health information needs. I am encouraged to see that the technical standards and structures the council recommends will allow for broad and safe use of health information in the future. I also appreciate the report’s openness about the privacy and identity management concerns involved in this significant undertaking.

Yet even as I affirm the overall spirit of the report, I find myself searching for a more explicit focus on the patient. I was hoping for a report addressing health information technology, but this report focuses more on health care information technology.

Effective management and use of health data must contribute to the improvement of the health of individuals, families and societies. I echo the comments of Chris Gibbons of Johns Hopkins Urban Health Institute, who emphasizes that health data includes the life experience of the individual, which encompasses—but is not limited to—clinical encounters.

Through my work with Project HealthDesign, I have learned that clinical data tell only part of the patient’s story. We must also value any data that the patient values. Patient-defined, patient-generated data such as observations of daily living (ODLs) contribute to a full picture of the patient’s health and complement clinical care data.

ODLs serve as personal health sentinels, which give individuals cues about their health or alert them to take personal health action. Because they arise from the patient’s experience, not the clinician’s perception, ODLs may be the most truly patient-centered type of personal health data. I believe the standards and structures PCAST recommends will prove sufficiently robust to handle even these types of data.

From its beginning, Project HealthDesign has advocated a vision of health information technology (HIT) in which applications draw data from many sources and synthesize and present it in ways that guide action. As bodies such as the ONC and FDA deliberate the PCAST recommendations and use them to guide the criteria for demonstrating meaningful use of HIT, I exhort them to hold fast to the fundamental purpose of effective health data management, which is to improve health.

Related resources
• Read the full PCAST report [pdf]
• Read Project HealthDesign National Advisory Committee member Chris Gibbons' [bio] comment on the report
• Read Project HealthDesign National Advisory Committee member John Halamka's [bio] primer on PCAST-related technological terms

ODLs at multiple levels

By Edmond Ramly, Project HealthDesign PhD Student, University of Wisconsin-Madison

As we investigate the observations people make in their everyday life, let's take a quick step back and look at the big picture.

Biomedical sciences have been improving people's health for centuries, and exciting new advances keep coming. At the same time, biomedical practitioners only get snapshots of people's health states. A person might spend three hours per year with a clinician, and then self-manage their health and health observations during the remaining 8,757 hours of the year.

Developing tools to support self-observations and integrate them into clinical workflows is a good start. But observations of daily living (ODLs) are relevant not only at the levels of the individual and the clinician. As we are seeing with the meaningful use of health IT conversation (see Navigating the path to Meaningful Use goals and They can’t do it alone), thinking about ODLs is very important at the health policy level as well.

More systematically, we can think of six categories of potentially relevant levels.

1. Infrapersonal: Air composition (pollutants, pollen), electromagnetic waves, radioactive emissions, etc.
2. Intrapersonal: Molecules, biochemical pathways, genetics, physiology, psychology, etc.
3. Personal: Sensory stimuli, feelings, behaviors, moods, attitudes, thoughts, decisions, etc.
4. Interpersonal: Patient-clinician interactions, patient-peer interactions, patient-family context, etc.
5. Extrapersonal: Culture, socio-economic status, insurance coverage, environmental context, etc.
6. Suprapersonal: Population health, health policy, health economics, etc.

Let me explain what I mean when I say ODLs may be relevant at these levels. At any given level, ODLs may be relevant because:

• There are things at that level that can constitute ODLs (e.g., ambient pollen count at an  infrapersonal level or thoughts at the personal level).
• There are issues that need to be addressed at that level in order to achieve the potential of ODLs (e.g., meaningful use of health IT by patients at the health policy level, understanding the underlying phenomena behind ODLs at various intrapersonal levels).
• ODLs might be highly idiosyncratic at some levels but share common characteristics at other levels (e.g., multiple instances of a given ODL may be very different across individuals but have similarities among individuals with similar cultural backgrounds).

Now, keeping in mind that the list I suggested is more explorative than exhaustive or definitive, it looks like we still have plenty of uncharted territory to explore as we continue investigating ODLs.

What's more, another exciting challenge will soon emerge as well: how do we integrate ODLs and what we know about them within and across levels? Integrating ODLs in clinical workflows and in health policy is only a start.

We have an exciting journey ahead!

Meaningful Use and Observation of Daily Exercise

By F. Daniel Nicolalde, Project HealthDesign PhD Student – UW-Madison

We are constantly making health choices in our daily living and everywhere we go. For example, Francisco decides to go for a bike ride and halfway into his journey he decides he would like to add 10 miles to his route. First, he has to decide whether this will be a good choice given his current physical condition or if it will put too much strain on his cardiovascular system and knee injury. However, without knowing his current physical condition, previous workout history and the state of his healing knee, he is unable to make an informed decision about whether or not to add the 10 miles (see "They can't do it alone").
 
On the other hand, professional athletes know very well their limits and how much they can push their bodies. Unlike Francisco, they have the tools (monitoring devices) and resources (people) that can help them make those decisions on the go, to make the best of the time they expend exercising and training. They have the data to push their bodies to the limit in order to go faster and for longer periods of time.
 
In the example of Francisco, a layperson, the circumstances are different. He does not have a team of consultants that can keep track of his vitals while he is exercising and storing observations about his previous workout sessions (see "I track my exercise - but then what"). At best, the information he stores is episodic and more often kept only as mental notes that he can use in the future as a point of reference.  
 
Observations from our exercise activities provide meaningful information for our health care providers and useful information for our self-care and self-management. These observations have the potential to optimize the time we spend exercising by customizing our workout routines to our specific needs.  
 
Going back to Francisco, if one of his goals is to reduce his weight, keeping track of every bit of information about his exercise routine can help his nurse practitioner and dietician guide him to a specific weight goal. In this particular case, personal health records have the potential to improve care coordination between his dietician, physical therapist, private coach and nurse practitioner in order to reach Francisco’s weight goal faster, as well as keeping him engaged in his health care.

Navigating the path to Meaningful Use goals.

By Tim Patton, Computation and Informatics in Biology and Medicine (CIBM) Trainee, Project HealthDesign NPO, University of Wisconsin-Madison

As we have posted (They can't do it alone - ONC needs everyone's input), we at Project HealthDesign want to make meaningful use really useful for patients.  At the same time, we want to facilitate communication between patients and physicians, nurses, public health workers and other clinicians.

ONC has stated that the goals of Stage 2 and Stage 3 are as follows: 

• By 2013, meaningful use of HIT should guide and support care processes and care coordination.
• By 2015, meaningful use of HIT should yield measurable improvements in quality, safety and outcome of care processes, including enhanced quality measures and extensive decision support at the individual and population level and enriched tools for patient self -management.

For Stage 2, it will be important to focus on the best use of resources.  Given the short time horizon, we would be best served to focus our efforts on:

• Generalized data structures that support physical activity, diet, and sleep. These are emerging as ubiquitous ODLs and represent the best value proposition as we begin to integrate support.
• Flexible tools that allow individuals to view the data as I see fit.  As we gradually come to understand the underlying ODLs, how we decide to view the underlying data will grow with our understanding. This might take the form of tools that will allow anyone who accesses that data to form a “view” that highlights the meaningful aspects while removing the noise.  Furthermore, if a lay person opts to share his/her view, others can understand the personal importance of ODLs (which may be very different from a professional’s view).

For Stage 3, it will be important to continue to build upon previous efforts to make ODLs more useful to everyone involved by:

•  Expanding support to other ODLs that fall outside the “big three” mentioned above.
•  Supporting disambiguation by combining multiple methods of capture (coding accordingly so others reviewing the data will know how it was captured).  For automated capture, calibration and algorithms can influence the data collected.  Self report suffers from a large array of influences.  To strengthen the information that can be derived from the data, it might be beneficial to combine collection methods (e.g., if automated collection agrees with self report, then we might increase our confidence that the data represents an accurate picture).
•  Recording the ambient context (reality mining) by connecting ODLs with other forms of data, such as GPS camera images, allergen counts, sound pressure levels, etc.  This might lead to new insights into how ODLs are related to contextual or environmental factors.
•  Creating observation standards that serve to identify the original source of the data, such as automated or self-report. This might play a role analogous to LOINC Codes, which can identify the specific lab test (with a set of standards and assumptions) that produced the value in the database.  As new devices and techniques come to market, they can be certified against such standards, thus insuring a certain level of consistency across vendors.

For ODLs to provide meaningful use, they must go beyond isolated data points and become truly connected to the full tapestry that describes personal health.