Federal Advisory Committees Seeking Input on Incorporation of Patient-Generated Data for Stage 3 Meaningful Use
ONC’s federal advisory committees (FACAs) held a full-day hearing on June 8 (written testimony can be found here) to explore how patient-generated health data (PGHD) might be incorporated into Meaningful Use (MU) of EHRs for Stage 3 of the EHR Incentive Programs. Some examples of PGHD are data from a patient’s personal health record, data from a blood glucose monitor, or information about a patient’s functional status. Three FACA workgroups hosted the hearing: The Health IT Policy Committee’s MU and Quality Measurement Workgroups, and the Health IT Standards Committee’s Consumer Engagement Power Team.
The hearing built off of not only the committee’s previous MU recommendations, but also its 2010 hearing on patient and family engagement. The blog generated several dozen thoughtful comments after the 2010 hearing, and we hope that will be the case with this blog post! ONC and the FACAs look forward to additional input via this blog, which will help inform the workgroups’ and committees’ future deliberations on recommendations for Stage 3. We encourage you to voice your perspectives in the comments section below.
In particular, the hearing and discussion among committee members generated many areas and concepts of great interest upon which we would appreciate comment. We’d greatly appreciate input on the following questions:
- How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
- Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?
- In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
- Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
- Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?
- For which health issues is it clear that patients and families are the authoritative source?
- How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
- Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
- What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
- How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
We look forward to hearing from you.
Virtual Health Assistants or Medical Avatars riding in on the proliferation of smartphones are poised to engage, enable, and empower patients like nothing we’ve ever seen. The opportunity to have this “constant companion” collecting, monitoring, tracking, coaching, and counseling will be transformative. In the new era of transparency, patients will now be exposed to dizzying amounts of information, so it will be no small step for mankind that Virtual Health Assistants can be programmed to clarify and interpret clinical information and make it actionable for patients. This will be particularly important for the millions of patients with low health literacy. An added bonus is that the Virtual Health Assistant can be programmed to collect and act upon intimate quality of life data, which is being discussed by many experts as the key to getting into position to motivate patients to be behaviorally, and therapeutically compliant. With the impending shortage of primary care providers, it is imperative for us to find ways to extend and expand their reach. Virtual Health Assistants seem to be more than up to the task and represent the only affordable way to pursue the goal.
If the question centers around the value of PGHD, with chronic disease patients accounting for 75% of our healthcare spend it is imperative for us to engage these patients in a way that enables providers to personalize the care in a meaningful way. Having intimate knowledge of a patients personal circumstances, motivators, obstacles, health literacy, compliance and adherence track record, etc. gives providers a purview of the patient that they have never had before. Added to existing information like labs, provider notes, family history etc, the physican now has a complete view of this patient from which to design, implement, and manage interventions. PGHD just might be the missing link. It is imperative that this be incorporated into the EHR as soon as possible.
1. How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
******Patients’ reports of symptoms and their knowledge of their own contraindications can make their way into EHRs via tablet surveys that take place before the appointment. These surveys will link to the EHRs via the unique patient identifier.
2. Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form? In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
******All PGHD does not need to be structured but patients should be assured that the data is secure and private. If possible a key word search function should be performed for terms that suggest, harm, extreme pain or other indicators that require further attention from a physician or ther provider.
3. Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
The datastream should be integrated into the EHR instead of the tablet survey mentioned earlier. Over time, different chronic conditions will develop key indicators (depression, weight gain, neuropathy development, etc.). An effort should be made to streamline the stream to ensure that only relevant data is mined. And above all else, the data stream should be private unless the patient indicates otherwise. THE DEFAULT SETTING FOR THE PATIENTS DATA SHOULD BE PRIVATE.
Great effort should be made to explain clearly the implications of sharing data and at that point the data should be made available
4. Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR? For which health issues is it clear that patients and families are the authoritative source?
5. How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
We should present the PGHD as the extension of the health history – the opportunity to capture information that providers may not be trained to ask. So, the suggestion to collect PGHD is a way to strengthen the patients healthcare
6. Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
You should be OVERLY prescriptive to ensure interoperability, usability and understandability – that is the key to a LEARNING HEALTHCARE SYSTEM (Abernethy, 6/12). Ultimately the patient’s health needs will evolve and he or she may leave the geographic area and want to bring with him or her the health record that has taken so long to build. The information belongs to the patient. ONC HIT should do everything possible to enable him or her to use it, learn from it and help other providers to do the same.
7. What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
I think PGHD can have a significant impact on all three of the things listed above, IF the information is repeatedly integrated into the EHR. More data points in a patient’s lead to improved clinical decision making and care coordination. I think the implications for quality measurement are different.
8. How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
Collection of PGHD can address health disparities; however, the information must be collected in multiple languages and using photos, video and other low-literacy methods.
PGHD can help facilitate discussions with the Care Team via the EHR in a few ways:
(1) Prepare for Visit – allowing the patient to take some time outside of the waiting room to plug in this data when coming for a visit
(2) Inter-appointment Monitoring – as stated above – the stream of information for chronic condition patient could make it’s way into the EHR in the background only alerting the care team when a threshold is hit for metrics (missed taking meds, didn’t pick up meds, labs spiked, weight gain, etc)
(3) Life Events – things that could cause stress should be noted by the patient / caregiver (authoritative source). Moving, New / Loss of job, new child, etc. These things coupled with day to day tracking of feelings can give insight into how the patient’s life is affecting their treatment and could lend itself to intervention by the care team to adjust accordingly.
All of these things should be “tagged” in someway such that interoperability can be ensured. If we are tracking specific items related to medications, preventative care, vital signs (weight, etc) and stress / life events – categories emerge in which almost all tie back to a discrete data element in an EHR today.
The EHR/MHR belongs to the patient/citizen/human being. The patient/citzen/human being should have the ability to go into the record and make changes/corrections. The real life example is my brother’s clinical record stated that he smoked 20 packs of cigarettes daily when, in fact, he smoked one. The correction (Mayo Clinic) took nearly 3 months and could have cost him his health insurance and clearance for further revision surgery on his failed medical device implant (FDA MedWatch Adverse Event #5009052). The providers are merely “riders” on the EHR/MHR and all information that is entered into the record is no longer “proprietary”.
PGHD will become an important part of or care system and management of this data will bring problems. Standard committees such as HL7 must provide structure to this data. Currently we are storing this type of data in PHRs, the data is grouped into a catchall “Vitals signs” elements of the CCR. I believe this needs to be addressed, that is a USER Data element/field should be integrated into messages, maybe all messages, e.g., Medications, add an optional field/element for USER DATA that would allow a patient to make an annotation to the record. The patient could provide feedback on the prescribed medication such as an error or problem. Structured and unstructured data could be used. The unstructured data could be parsed and coded.
There is an HL7 group working on this now, I would be happy to connect you
we’ve piloted use of patient entered data from web based surveys feeding into the EMR, which have been very helpful to increase efficiency and comprehensiveness. Other valuable tools we’ve tried: using the survey responses to trigger educational messages and decision aids to encourage shared decision making. We’ve also used feed forward reports to summarize this data in a quickly interpretable format for clinicians.
Thanks for the opportunity to give input on this issue.
What patients *know* and what informed patients *prefer* are critical forms of patient-generated health data (PGHD). What do patients know about the risks and benefits of health care options? What do they know about the necessary process of care and how that process may (or may not) fit into their lifestyle? Given what they know, what do they prefer?
The health care system and individuals within it spend a great deal of time and resources devising ways to avoid clinical misdiagnosis. But as Al Mulley, Chris Trimble, and Glyn Elwyn explain in a recent King’s Fund paper (http://www.kingsfund.org.uk/publications/patients_preferences.html), little attention is paid to the misdiagnosis of patient preferences. While the consequences of misdiagnosed preferences are usually silent—regret, frustration, sadness—they too have significant consequences for individuals and for the health care system. Just as the EHR records physicians’ conclusions and observations, it should also record what patients care about and what they do and not know. A complete medical record should contain both.
The most important times to collect and record information about patient goals and concerns and what they know, and for providers to attend to it, is when a specific medical decision is made. Many screening and diagnostic tests, prescription medications and surgical interventions are clear events for which decision making is almost always relevant. A good start would be to develop systems that would prompt providers to collect this information from patients before they could order selected ‘preference sensitive’ tests or treatments. The systems could require that patients answer a brief set of questions that are tailored to the decisions. Instruments to assess patient knowledge and preferences have been developed and tested for many decisions, and could be readily created for many more.
Patients with chronic conditions are very often clinically or sub clinically depressed. They nor their families often do not discuss this with the physician and they are able to get themselves “up” enough during visits that this is missed. The EMR has the potential of capturing mental health problems as it is not face to face and people often interact at a more ‘real’ level with the computer. I am not quite sure how to do this but one possible important use of EMR is to capture symptoms of depression. I think that in the very near future we might be able to use computational linguistics to do this. Random thoughts but hopefully helpful.
The Children’s Partnership is pleased that ONC is considering adding patient-generated health data (PGHD) into the stage 3 meaningful use expectations. Patients and their families are a valuable source of information to providers, one that is often undervalued and underutilized. Incorporating PGHD into the EHR will add this information into the clinical decision-making process more consistently, while also promoting helpful conversations between patient and provider.
How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
Patients and their family caregivers are the primary source of information as to family health history, health habits and exposures, health complaints, many indicators of health problems (e.g., pain), the experience of a particular treatment, and other highly relevant information. Such information can help the provider identify and treat a patient more effectively. PGHD can easily be incorporated into an EHR through electronic pre-visit surveys, linkages with personal health records (PHRs), and by capturing email that a patient sends the provider. In addition, remote monitoring tools can automatically send data to the provider, such as blood sugar levels, alerting the provider to concerns while also creating a longitudinal record in the EHR. Patient generated data that is submitted between visits can be particularly important to ensuring effective care. Patient visits can be rushed and patients and their caregivers may not remember to bring up important issues during the office visit, or may not have the critical piece of information with them at the time of the visit.
Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?
While PGHD should be structured when possible, it is also important that patients and family caregivers be able to submit information in free text and by scanning documents, among other available means.
In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
The PGHD should be captured in a manner that indicates the provenance of the data (date entered, who entered it, and contact information). In fact, this is important whether the data is added by the patient, by the family caregiver, or by another provider — since it may be important to follow up with the individual that added the data. Furthermore, we believe it is very important for patients and caregivers to be able to review their record and contribute missing data and flag/correct data in their own health record. When this occurs, it is important that the original information is retained in the record, but that the correction (and its provenance) be easily identifiable for the provider.
Patient generated data is critical to improved outcomes, because for the vast majority of patients’ lives they are NOT in contact with the healthcare system. Therefore, the professionals serving them need to understand their strengths and needs for being able to manage their health on a daily basis. As a former hospital social worker, I know that psychosocial information like: family support, transportation, ability to afford medications, in-home assistance with care needs not covered by home health, safety of home environment, and ability to understand what they are supposed to do to manage their health is crucial. Lacking any one of these things can completely derail an otherwise perfect plan of care, and inevitably there is a readmission. Hospital social workers already collect much of this information, but is it included in the EHR? Could certain screening questions be asked of the patient prior to or immediately after the admission using a method to allow them to enter the information themselves? This would save staff time, provide a method of triage, and possibly yield more complete and accurate information. In the physician practice, this kind of information would provide significant insight into an individual’s ability to incorporate the mangagement of their health into their daily lives, and would reveal opportunities to link them with community supports or make an alternate plan that is more work-able, given their situation.
Patients with Chronic Conditions and data streaming information to the EHR
1. Collection of information can be obtained by a dynamic personal health record linked to the patient history (under patient entry) that includes health literacy tool ( survey), patient activation measure ( tool), pain management index, mental health status check ( survey or tool), symptom severity index, medication efficacy index ( plus adverse . side effects measure, SES ( Socio-Economic- Status) index, community health resource assessment, caregiver provider status, and timeline changes index for the above on quarterly or semiannual basis?). This information would necessarily be both structured and free text based and then screened by computer algorithm and flagged for staff attention as needed for further clarification, verification, etc. This information is melded with known clinical condition and symptoms of patient I( if already in system) or flagged for recall, new patient visit, followup labs, etc.
Health issues that are authoritatively sourced to the patient or family?
1. These could include genetic tests, family history that are positive for known conditions. Conditions that precipitated health problems congenital disorders, environmental contamination, depression, anxiety, PTSS, concussion history, or that the family has prior knowledge of that may not have been provided, etc. Some other things that come to mind are drug and alcohol abuse, physical or sexual abuse, eating disorders, poor hygience, behavioral disorders triggered by known stressors. This is a tough question since much of the information may be guarded or suppressed as part of the family dynamic. Perhaps a test or tool that indicates predisposition / tendencies that indicate problematic concerns can be administered. However, a home visit at the least and more preferably a formal intake would be advised.
2. The other side of this question could be what health issues could be sourced with appropriate interventions and support so that the family or patient could self manage after treatment, intervention, education, and support has been provided. Chronic conditions that might be proactively managed would include diabetes, asthma, arthritis, etc provided patient and family were adequately aware of when to seek medical guidance ( red flags,etc).
How can collection of PGHD address health disparities and what cautions exist to ensure that disparities don’t widen?
1. Computer algorithms could be developed that check PGHD against the existing patient EHR that automatically flag alerts similar to medication alerts when combined with other medication, homeopathic remedies, etc. As part of the of the PGHD perhaps there is a weighting of accumulated data that triggers a response when entered into the EHR. I envision a program similar to Watson that collects and processes all of the data input from the PGHD and EHR and then alerts a care provider team member with known conflicting information, potential adverse events or side effects, or indications for specific followup test / provider notification.
• How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
o Knowledge of symptoms, health status, conditions, contraindications. All of these and more beg the question, how does Patient-Generated Health Data (PGHD) get integrated into the EHR in a meaningful way? Testimony given by providers, patients, researchers and policy leaders to the Federal Advisory Committee Act members at the recent PGHD hearing outlined many successful approaches. Testimony stressed that successful use of PGHD had to be meaningful and useful to all parties, and most of the testimony favored structured methods of collection either through tethered patient-facing systems or standards-based integration. All indicated common success factors:
1. Workflow should accommodate PGHD.
2. Assumptions and goals were agreed upon by all parties.
3. Use of the data (frequency, roles for sharing, data to share and accuracy) were well understood by all parties.
Each participant reported that PGHD contributed to better quality of data, higher levels of patient engagement and better outcomes.
Take away: Set clear objectives and goals for PGHD, and accommodate workflow. PGHD complements the patient record.
• Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?
o Both structured and unstructured data are needed.
If one of the overall goals is to include the voice of the patient, we need to think about how patients will provide information. The answer? Just as any other care team member’s finding, result or observation is currently provided. A patient observation may contain a structured “envelope” with a narrative within. Patient narrative is important to capture, because the voice of the patient given in an unstructured way can provide rich, nuanced data and information that goes well beyond the facts presented.
Including patient narrative or observations in the current workflow may work. Concerns that were voiced in the PGHD hearing include issues of physician responsibility, accuracy, expected actions, frequency of use and more.
PGHD can occur as a response to a specific request for information. For example, a result is often a response to an order and is highly structured. A patient response to a provider order or request for information is well suited to structured data and more easily integrated into the EHR workflow. Standards such as Logical Observation Identifers Names and Codes (LOINC) -based questionnaires can serve many purposes: pre-visit preparations, administrative data gathering, patient histories, health status, preference-sensitive care questionnaires, decision aids, home tele-medicine, patient education results, medication reconciliation and more.
PGHD questionnaires and responses present few technical challenges and are more easily integrated into the workflow.
Take away: PGHD questionnaires and responses are meaningful to care and outcomes. Standards exist, meaning that PGHD can be implemented in the first phases of PGHD. Patient narrative observations may be a good second step.
• In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
o The PGHD hearing testimony offered great insight on this question. Each successful case discussed a good plan, with clear assumptions and workflow integration. The white paper presented also provided some good insight, saying in effect that providers are held responsible for data that is judged to be material to care and accepted into the EHR by the provider. Although each group that presented mentioned having these same concerns prior to implementation, they reported that with thoughtful implementations, the concerns were largely ill-founded.
Take away: Problems anticipated with PGHD did not materialize when organizations planned well for implementation.
• Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
o Data can be collected by the patient at different speeds and with differing frequency, but data uploads can be based upon an entirely different cadence. This upload frequency should be based upon patient/clinician agreement.
Take away: Physician/patient agreement on frequency of collection and upload should be in place.
• Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?
o Consistent with any other attributions for clinician, lab and other results, patient attribution should follow the same standards. The work being done in the consolidated CDA can accommodate PGHD with appropriate attribution and metadata. Efforts by HL7 subteams are underway (with completion dates in the early fall) to have an overarching PGHD template implementation guide draft complete. The PGHD testimony emphasized the need for PGHD attribution and metadata to flow with all data.
Take away: PGHD should follow the same standards as any other result or observation, including metadata.
• For which health issues is it clear that patients and families are the authoritative source?
o Patients contribute the majority of information within a patient record, and attribution is important. But, it was also discussed in the PGHD testimony that the clinician gleans additional information from the patient interview. At times this information conflict, add or confirm the PGHD. Both perspectives are important to care. Patients can provide authoritative information on their own administrative data—their values, preferences, decisions, directives and personal observations and results—in any state of health.
Take away: The clinician and the patient have valuable information to provide, and both—with proper attribution—should be considered.
• How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
o Providing direction, standards and the mechanisms for HOW data is collected and integrated seems like a logical first step. The emphasis should be in three areas: 1. patient response to clinician requested information (questionnaire structure as indicated above), 2. patient-initiated data, and 3. patient and all care team members participating in a collaborative care record.
o The emphasis on WHAT should be collected will be highly variable based upon the care setting, disease state or simply the individual and personal nature of care. But prescribing the use and rewarding the volume of use is an appropriate policy goal.
Take Away: Policy and standards for the HOW are needed and doable; the WHAT should be market- and care-driven.
• Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
o As indicated above, the HOW should be the emphasis of standards and policy, the WHAT should be left to the clinician and patient, and the capacity and volume should be a measure of policy.
• What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
o Preference-sensitive care represents the majority of care provided. Even where evidence-based care is prevalent and a prudent choice for the provider, the patient’s values, preferences, intolerances and direction should be considered. Meaningful choice for patients should include the ability to understand their current status, choices available and risks and outcomes, and share their decisions with the provider. This shared decision making presents the greatest opportunity to improve care and reduces costs. When informed, patients often take a more conservative approach to choices presented.
o PGHD testimony also discussed the use of current computerized physician order entry (CPOE) technology as a logical place within the workflow to incorporate shared decision making. PGHD intolerances, allergies and specific direction as exemplified in Orders for Life-Sustaining Treatment (OLST) can be incorporated within the current workflow.
o
Take away: PGHD in shared decision making can inform care and exist within the current workflow
• How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
o Access to information and creation of information needs to meet the patient where the patient is. Increasingly, this means mobile.
o Language tools online provide the means for patients to communicate online through PGHD, at times providing better access and communication than in face-to-face meetings.
o The National Partnership for Women and Families released a study demonstrating that EHR can increase confidence in providers in some populations. PGHD may also build upon this confidence.
Take away: PGHD and EHR could help to promote parity in care.
The College of American Pathologists appreciates the opportunity to provide comments on the important topic of how patient-generated health data (PGHD) might be incorporated into Stage 3 of Meaningful Use (MU). The College of American Pathologists (CAP), celebrating 50 years as the gold standard in laboratory accreditation, is a medical society serving more than 18,000 physician members and the global laboratory community. It is the world’s largest association composed exclusively of board-certified pathologists and is the worldwide leader in laboratory quality assurance. The College advocates accountable, high-quality, and cost-effective patient care.
Laboratory testing and pathology diagnostic information are without question a key influence on health care decision making driving an estimated 70% of clinical decision making. Laboratory testing results comprise a large portion of any patient EHR and influence a significant amount of medical spending. Pathologists directing laboratories are working to support hospitals and EPs meet Meaningful Use and form the backbone of the informatics for coordinated care arrangements including ACOs.
Pathologists are physicians who guide and influence diagnostics and treatment decisions as part of a multi-disciplinary patient care team. Pathologists enhance quality and patient safety as proper testing enhances coordination of care, minimizing complications, unnecessary treatments and readmissions.
Pathologists also understand disease and treatments at the molecular level and are in a position to ensure appropriate test selection and determine the optimal course of therapy and monitoring patient progress on key clinical outcomes. For instance, CAP developed a free resource entitled, MyBiopsy.org, for people who have been diagnosed with cancer and their loved ones to help them better understand their illness. Therefore, CAP supports the various HIT Standards and Policy Committees’ Workgroups intent to develop objectives that respect patient autonomy and promote informed decision-making.
The CAP believes that a key issue for ONC is the need to establish appropriate and stringent requirements for data integrity, accuracy, source identification, and method of delivery and the retention of necessary additional information for context (i.e. metadata). Knowledge of the information’s source and how it has been controlled will guide the degree to which the information might inform patient care or be utilized in quality improvements. In promoting patient engagement, the Workgroups and ONC would be advised to keep some key issues in mind.
Outside Institutions, “Home” Data and PGHD
For instance, patients will often bring in results from outside institutions and independent labs when arriving for an office visits. This practice may be useful for patient engagement, but it raises concerns as well. The dangers of unsupervised incorporation (e.g. scanning) of this information into an institution’s EHR should be well understood. The data may not mesh well with local reporting standards, resulting in misinterpretation by a physician. Further, the results may simply be wrong or in conflict with local EHR data. To prevent potential misinterpretation, patient-generated data entered into the EHR must be clearly identified as such and preferably set apart from provider-generated data. One potential solution would be the addition of disclaimers that made clear to the treating physician when data was patient-reported or acquired separately from the laboratory.
ONC should create user interface requirements that will assure providers can clearly, consistently, easily and prominently identify the source of the information and any other important relevant context such as reference ranges, laboratory comments and flags that are needed to correctly interpret results. Origination source, information accuracy and completeness must be retained across the parties that exchange data as the data flowers from the originator (e.g. patients, other provider or other laboratory) to the transporting system/intermediary (e.g. portal or health information exchange) to the receiving systems that manage and present patient information for clinical decisions and care. Implementing of appropriate EHR data integrity processes and practices will reduce potential liability for the provider receiving and action upon the information and increase patient safety.
The CAP would like to point out other dangers to patient safety in this area. The practice of keying in outside laboratory patient generated data directly into the EHR creates risks from the frequency of key entry errors; the lack of compatibility of references ranges and inability to determine what testing methods were used and the credibility of the source data; and problems with accountability for results if there is a mixture of institutional laboratory, outside laboratory and patient-generated data. Further, there can also be problems trouble-shooting laboratory results; lack of information on pre-analytic specimen handling which can adversely affect the reliability of the results as well as a lack of ability to trend analytes over time if done by different methods over time.
Additionally, in the clinical setting, physician judgment, repeat testing, and other secondary checks may minimize the risk of harm to patients. These checks may not be present with home use devices. As with all data the source will need to be clearly identified and in particular boldly noted what constitutes PGHD. If readings from a machine (e.g .glucose meter, blood pressure), instrument data will need to be included, noting when possible, the last time quality checks was performed.
Standards and Patient-Generated Data
It’s important to recognize that not only is there a need to standardize the message structure and vocabulary for coding, but it is also advisable to normalize the ancillary content (metadata) so like laboratory data can be aggregated and trended when possible. For example, different testing methodologies for the same analyte may yield different values and reference ranges in different settings or populations. That means having the machine “understand” units of measure, methodology, reference ranges, patient demographics, sample source sites, collection methodologies etc. so that decision support is robust, even with data elements aggregated across facilities and in settings such as the patient’s home.
The CAP believes that PGHD should only be recorded in the EHR if it is isolated and clearly, consistently, easily and prominently identified as PGHD information. Receipt of external laboratory data via hard copy, scan or PDF provided by the patient, another laboratory or another provider should not be comingled with internal laboratory data within the EHR. External laboratory results are those results from any non-contracted laboratory of patient-performed, which the provider received. Internal laboratory results are those originating from a laboratory contracted with an eligible provider or eligible hospital.
Use Cases
The CAP recommends that ONC and its advisory committees consider the following use cases (among others).
• Patient Generated or Interpreted Information – e.g. result of a pregnancy test, report of a symptom (rapid pulse) or other health factor/change:
Source test result or clinical observation may not be verifiable – requires trust of the patient’s interpretation and,
o Information may have been received via oral or paper report and entered (correctly or incorrectly by clinician or clerk)
o Information may have been directly entered and communicated to provider by patient via portal, messaging platform, or other method (potential errors of entry or interpretation by the patient)
o Patient Data Generated by a Home Diagnostic Device and Transmitted via Interface to the Provider – Potential error or misuse of diagnostic instrument or specimen collection
o Potential issue with calibration, lack of, or outdated quality control for diagnostic instrument
o Potential user Interface or transmission errors
o Patient Provided or Requested Documentation or Test Results Generated by Another Provider or Laboratory
Submitted via Health Information Exchange
Information submitted by patient via fax, paper report or other means (possibly incorrectly copied or incomplete representation)
Thank you for this opportunity to comment. The CAP stands ready to provide any policy or technical assistance that may be helpful to the Workgroups or ONC as you continue to develop requirements and suggestions for Meaningful Use Stage 3.
While promoting this important aspect of patient engagement, it is crucial that patient authentication issues be addressed. Unlike face-to-face visits where we as physicians are highly confident that the data provided by the patient is indeed coming from that patient (or family), over the internet we need other methods to ensure who the author is. While there are online authentication systems that ask patients to answer some personal information, I am aware of several cases where mothers of 19 year old girls knew the answers to those questions and illegally accessed their “child’s” medical records. Similarly I’m aware of spouses doing the same thing. At my healthcare organization (Reliant Medical Group, formerly known as Fallon Clinic), we give the patient an alphanumeric “key” generated from our EHR that they must provide online (in addition to providing other demographic information) in order to provide access to their records online and to provide information online that we load into their EHR record. This “key” is either given in person or through direct conversation over the phone with appropriate challenge questions. Using this methodology, we are confident that we are not allowing inappropriate access to patient records, and that when I load a patient’s home blood pressure readings into our EHR via Microsoft HealthVault, I truly know who they belong to. Furthermore, when I pass those readings onto other physicians, they can be confident in their source as well.
In order to convey that “transferrable trust”, there must be minimum standards for authenticating the source of patient data. I encourage you to consider a methodology similar to the one I describe above.
I wan to comment on two types of information that patients and caregivers can provide that is important to providing safe and high quality care.
Patients and caregivers (usually a family member or friend) know the day to day and intitimate details of how the patient’s chronic condition affects them. It is important information for providers to have. A structured format would help collect this info through patient portals and then on into the medical record. In addition to the structured information room can be made for narrative comments. To control the extent of informaiton there can be a word limit.
Unless a physician’s (or other provider’s) practice revolves around physical disability most providers do not understand the impact of functional problems on a patient’s life and health. This is one example of information that patients and caregivers can provide that will help providers with both diagnosis and treatment of those with chronic conditions. Suzanne Mintz Co-founder and CEO Emeritus National Family Caregivers Association
Patient/caregiver generated data can also help solve the problem of the lack of identification of family caregivers in medical records, at least until that becomes common practice. Although obviously a major player in the life of someone with a chronic condition(s) family caregivers remain undocumented workers. There is no place on medical records that captures this information, which is not the same as next of kin data, even if it is the same person. Primary caregiver data should capture the length of time as a caregiver and at least some of the activities that the caregiver provides. It is also critical that the impact of the caregiving on the caregiver’s health be captured so that his/her own doctor can monitor his/her health. There is a growing understanding of the need to capture caregiver data and a growing interest in making it happen. Stage 3 can play a significant role in remedying this glaring omission on medical records.
Thank you for the opportunity to provide input on this critical issue.
How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
Data captured during office visits require the patient to generalize symptoms experienced over long periods of time. Meaningful Use policy can encourage the use of detailed and timely PGHD by creating a broad mandate for their capture. The policy should encourage physicians to capture regular symptomatic, quality of life, or mental health status for a subset of patients. The key is not to be too prescriptive, but to acclimatize both patients and physicians to regular data exchange, even if its capture and use are not yet perfect.
While many patients already track their own symptoms, very few have access to tools that allow and encourage data to be transmitted to their providers. Highly engaged patients may currently use tools as simple as free-form diaries or more complex mobile apps to track their own health. As this trend continues, Meaningful Use policy should aim to allow as much PGHD from as many sources as possible to be accepted into EHRs.
Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?
Some PGHD is stored in free-form text format and attached in a manner similar to provider notes in an EHR. Patient diaries, for example, are often unstructured records of their symptoms and self-management and can be transferred as text into EHRs to provide additional context to providers. The priority in the short-term is the capture and availability of the data, not necessarily structure.
However, the majority of PGHD can and should be eventually captured in a structured way. All of the key elements of symptomatic data (timing, intensity, duration, triggers) can be recorded as structured data, using rating scales for the more subjective elements such as intensity. Creating standards for capturing symptomatic data will be helpful.
In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
Providers should have customizable platform that allows them to start small and grow in terms the breadth and depth of the data they allow patients to send. The platform must encourage the patient to set own their security level for shared data and to actively choose which data to share with providers and store in the EHR. On the provider side, there will need to be a gatekeeper process in which someone from the care team reviews data and decides whether to integrate it into the EHR. It will be critical to acknowledge both the patient’s rights to privacy and the physician’s clinical discretion in any transfer of data.
Some types of PGHD ultimately may not be easily captured or utilized in an EHR. Due to limitations in data mining ability within EHRs and the increasing availability of useful third-party applications, certain types of data might be best leveraged outside of the EHR. If useful PGHD for any reason cannot be captured directly into the EHR, incentives should still exist for providers to capture and utilize that data, whether it is in a PHR or other platform. Ultimately, the question should be what will add the greatest value for patient and provider while acknowledging the limitations of EHR systems.
Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
The primary advantage of PGHD is that it provides a stream of data for the 99% of the time that patients are not in the office. This stream of data should be integrated into the EHR whenever possible. As mentioned previously, there may be certain data streams that are more useful stored and manipulated outside of the EHR.
One approach would encourage and allow physicians to make a note in the EHR whenever PGHD is flagged or leads them to follow-up with the patient in some way. This would allow a physician to integrate enough of the PGHD stream into the EHR to record the justification for any clinical decision-making process.
Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?
PGHD that can be directly linked to existing elements within the EHR should be tagged as such. The patient data should still be identified as PGHD but be located in the EHR. Today most patients are only able to enter data stored separately in a PHR that is not directly linked to their EHR. The ideal would be for both patients and providers to see all data in the EHR, with provider data points highlighted and supported by a more constant stream of PGHD.
For which health issues is it clear that patients and families are the authoritative source?
Any health issue with many symptoms to track over time will generate useful PGHD. This is especially true for patients with chronic conditions such as asthma, diabetes, COPD, cancer, obesity, or heart disease. In addition, for conditions with subjective and difficult to measure symptoms, such as depression, PGHD is extremely important for the clinician. Increasing this data beyond the exam room would be extremely helpful.
However, PGHD is important for any type of patient regardless of their condition. Even healthy patients with limited symptoms to record or who take few prescription drugs should have long-term health goals to track. Any recorded data on self-management can help physicians provide better, more personalized, longitudinal care.
How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
Providers will be likely most concerned with the usability of the data they integrate into EHRs and the risk of being inundated with too much data. As mentioned before, they should maintain a “gatekeeper” role controlling which data is relevant enough to merit inclusion into a patient’s EHR.
In the near-term, physicians will also want flexibility for them and their patients in how they capture and use PGHD. Some will prefer capturing as much structured symptomatic data as possible into the EHR, while others will rely on device-captured PGHD that can be easily analyzed outside of the EHR. Any Meaningful Use Stage Three rule should acknowledge the diversity of patient populations and types of PGHD that might be captured.
Systems, platforms, and apps for capturing PGHD are also still emerging. The focus should be on creating a broad incentive to start utilizing PGHD to improve care and patient engagement. This should help build momentum among patients, providers, and IT vendors.
In the future, interoperability of data between providers will need to be addressed more fully. In the near-term, however, it is most critical to encourage the capture and use of PGHD and the development of an ecosystem of processes, platforms, and applications.
What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
Increased collection and use of PGHD should improve the quality of clinical decision support tools by creating new triggers. The implications for care coordination will depend on whether providers leverage PGHD beyond their own walls and share PGHD with other providers. The potential exists to use PGHD increase the quality of care summaries and patient handoffs between PCPs and specialists. However, interoperability issues and lack of standards for PGHD could hinder this process.
How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
PGHD, if properly shared with public health authorities, should help to better identify large pools of underserved patient populations. Overstretched Medicaid programs can leverage PGHD to monitor patients and identify problems before they result in an ED visit. Due to disparities in Internet and broadband access, the emphasis should be on mobile solutions.
GENERAL COMMENTS
Siemens Healthcare Health Services (Siemens HS) thanks the HIT PC and HIT SC for the opportunity to comment on incorporation of patient-generated data for stage 3 meaningful use. Siemens HS is the information technology (IT) business unit of Siemens Healthcare, with worldwide headquarters in Malvern, PA., employing about 5,000 individuals worldwide. We commend the committees on their support of patient engagement for the betterment of patient health as well as a more accountable and coordinated health system.
Our responses to the ten specific questions are included below. In addition, in “Other Consideration” at the end, we have added a comment on the important policy issue of responsibility, that was not asked.
QUESTION 1: HOW CAN WE ENSURE THAT PATIENTS’ REPORTS OF SYMPTOMS AND THEIR KNOWLEDGE OF THEIR OWN CONTRAINDICATIONS MAKE THEIR WAY INTO EHRS?
RESPONSE: Much patient-reported information (much more than symptoms and contraindications) is already incorporated through normal clinical practice into paper charts and EHRs through registration processes, self-service kiosks, assessments, interviews, electronic or paper “clipboard” (e.g., patient listing their allergies, home meds, family history, recent symptoms, surgical history). Often these are captured during registration or while the patient is waiting in an office, and may rely upon imperfect memory. We recommend starting by capturing health information in the patient’s own words. Knowing the patient’s perception, even if it is erroneous, can be useful. Patients should be given the ability to enter/upload their data from multiple devices at home or other locations, or from PHRs, when they have more time available to collect the data more comprehensively and accurately than they do in a provider facility. Physicians need the ability to view the information, verify its correctness and relevance, and discuss it with patients, to decide what is relevant to incorporate into the EHR, just as they do without EHRs.
SUMMARY: For MU Stage 3, define criteria for EHRs to accept PGHD, initially in either unstructured or structured formats through a variety of methods, to avoid barriers and overprescriptiveness.
QUESTION 2: ALTHOUGH THERE CLEARLY IS A NEED TO HAVE A STRUCTURE FOR PGHD, DOES ALL PGHD FOR CARE MANAGEMENT NEED TO BE IN A STRUCTURED FORM?
RESPONSE: The question assumes, without clearly stating the case, that structured PGHD is necessary. While we agree with the benefits of structured data, our answer is no, all data does not need to be structured. Structured data has precision but not the expressivity of natural language. The patient’s own words are important to capture. However, exports from patient PHRs or clinical devices should include structure compatible with MU formats (e.g., Consolidated CDA) wherever applicable, but text answers and unstructured documents will still be valuable. Advance directives are an extremely important type of PGHD that may not be structured, and should not be forced into a structure.
SUMMARY: See response to Question 1. Encourage but do not require structured data content standards, but define a clear roadmap for standards to come, compatible with data standards for EHRs.
QUESTION 3: IN ORDER TO MANAGE THE LEGAL, POLICY, AND OPERATIONAL ISSUES ASSOCIATED WITH PROVIDER COLLECTION OF PGHD, WHAT SHOULD INDIVIDUAL PROVIDERS DO TO ENSURE THEY HAVE A PLAN FOR MANAGING THAT DATA?
RESPONSE: All data including modifications, whether from patients or others (e.g., professionally-sourced data), should have clearly documented provenance metadata (information about the source person, relationship to patient and/or organization, reliability, date, restrictions on use, etc.), so that it can be interpreted with proper context. Providers should have the ability to exercise judgment depending on whether the provider requested the data or not. For unsolicited PGHD, providers should accept it but have the ability to segregate it without being required to incorporate it into the EHR.
SUMMARY: For MU3, clearly define provenance metadata requirements to inform providers in their clinical judgment on how they will use the data.
QUESTION 4: PATIENTS – PARTICULARLY THOSE LIVING WITH CHRONIC CONDITIONS – HAVE AN ONGOING STREAM OF INFORMATION, FOR WHICH CLINICAL ENCOUNTERS WITH THE DELIVERY SYSTEM ARE INFREQUENT DATA POINTS. WHAT IS THE RELATIONSHIP BETWEEN THAT DATA STREAM AND THE EHR?
RESPONSE: We believe that clinicians want relevant information, but not “all data” whether from previous providers or from the patient. Patients should have a way to select the relevant information subset from their record (if extracting from a PHR, for example). But clinicians should also be given the opportunity to drill down into the detailed data if necessary, e.g., by a patient granting a provider read-only access to her PHR. While aberrant data should be flagged for review, there are even cases where “normal” data should be reviewed in preparation for the next visit. For example, trends in the data will give clues for conditions such as prediabetes and hypertension. Even patient comments, not just raw data should be accessible (e.g., associated with a Holter monitor, or migraines).
SUMMARY: Focus on relevance, being careful not to overwhelm clinicians with too much data. Allow provider access to PHRs to view additional data where needed.
QUESTION 5: ALTHOUGH PGHD HAS SOME SPECIFIC NEEDS, IDENTIFICATION AND SOURCING OF ALL DATA SOURCES ARE IMPORTANT; HOW CAN ADDRESSING PGHD MANAGEMENT ISSUES HELP CLARIFY HOW DATA SOURCES ARE TAGGED MORE GENERALLY IN THE EHR?
RESPONSE: Tagging of data sources should be done consistently regardless of source. PGHD, while important, does not necessarily introduce new requirements for tagging of data. We recommend that previous ONC and HIT SC work regarding metadata tagging (including provenance) be reviewed. If some metadata are added based on PGHD requirements, they should be made available for tagging other sources as well. Finally, multiple sources (patient, caregiver, family members, other providers) may provide varying/conflicting information on the same subject, so that evidence of what people “believed” should be able to be recorded, even though the provider may ultimately decide which version of the truth to act upon. EHRs should give the provider the capability to document the reliability of the source.
SUMMARY: Sourcing (provenance) is essential. See response to Question 3.
QUESTION 6: FOR WHICH HEALTH ISSUES IS IT CLEAR THAT PATIENTS AND FAMILIES ARE THE AUTHORITATIVE SOURCE?
RESPONSE: Only the patient and family know what the patient is really doing or their history regarding meds, allergies, diet, exercise, functional status, levels of pain, past med history, social history, SOAP note “subjective”, other symptoms, and family history, since individual providers and even HIEs usually only have a small “slice” of the patient’s lifetime health data. But there are exceptions to any rule, and the “authoritative source” depends not only on the type of data or health issue, but on the trustworthiness of each specific source of information. Many patients may generally know the info above, but patients with certain conditions (e.g., dementia, delirium, or other mental illness) are not always reliable sources.
SUMMARY: In typical cases, the patient is authoritative on many issues, but the provider must exercise judgment as to trustworthiness in each SPECIFIC patient interaction.
QUESTION 7: HOW SHOULD WE BALANCE THE NEED TO BUILD IN THE CAPABILITY FOR PROVIDERS TO INCORPORATE STRUCTURED PGHD INTO THE EHR WITHOUT BEING OVERLY PRESCRIPTIVE?
RESPONSE: Providers cannot totally control or predict patient behavior. They “don’t know what they don’t know” so it would be too limiting to insist that providers only gather certain structured data from patients. Patient should be allowed to provide any information that they deem relevant for the provider to know, in their own words even if it is unstructured. However, where possible patients and their agents (caregivers, PHR suppliers, etc.) should be encouraged to use standard formats, vocabularies and transport. For widest adoption, easy-to-use structures to gather data are recommended (e.g., an allergist questionnaire with a 1-5 scale for 20 symptoms). If standards are used, they need patient-friendly user interface.
SUMMARY: For MU Stage 3, avoid being overly prescriptive on which data must be gathered or how it must be structured. Emphasize adoption over sophistication by starting with approaches such as questionnaires that are easy to use.
QUESTION 8: SIMILARLY, HOW SHOULD WE BALANCE THE CONCERN ABOUT BEING OVERLY PRESCRIPTIVE WITH ENSURING A CERTAIN DEGREE OF INTEROPERABILITY, USABILITY AND UNDERSTANDABILITY OF PGHD?
RESPONSE: Usability in terms of user interfaces and workflow should not be prescribed by regulation. However, we recommend that interoperability standards between patient sources (e.g., PHRs, patient portals and patient devices) and EHRs be defined, leveraging standards already in place for MU (e.g., NwHIN Exchange and Direct, and Consolidated CDA), since that will result in the highest degree of information exchange, the quickest uptake in the industry, and the least burden on developers. But where standardized data cannot be provided by patients, human-readable text data should still be exchanged, as it is far better than nothing.
SUMMARY: For MU Stage 3, do not regulate PGHD usability and workflow. Rather, recommend and set a direction for standards, but accept unstructured text to avoid barriers to starting the free flow of PGHD.
QUESTION 9: WHAT IMPORTANT IMPLICATIONS DOES PGHD HAVE FOR THE ROBUSTNESS OF CLINICAL DECISION SUPPORT, QUALITY MEASUREMENT, AND CARE COORDINATION?
RESPONSE: PGHD can certainly help clinical decision MAKING (which is broader than automated clinical decision support rules and alerts) and care coordination. PGHD can broaden the context for clinician understanding of the patient’s progress, e.g., monitoring effectiveness of treatment compare against the patient’s pain log, or monitoring glucose, blood pressure, and weight before and after an intervention. Even absence of PGHD (where it was requested) may help providers identify patients who are not following the regimen and may be at risk. Patients may fill out risk calculators which send outputs to providers, though there would be a need to assess which calculators are standardized and acceptable. As for quality measures based on PGHD, the field is quite new, and structured PGHD for e-measures is practically nonexistent, so we recommend that such measures be carefully vetted and field tested for efficacy before being mandated.
SUMMARY: Focus broader on assisting clinical decision MAKING rather than narrowly on automated clinical decision support rules or quality measures dependent upon specific structures.
QUESTION 10: HOW CAN COLLECTION OF PGHD ADDRESS HEALTH DISPARITIES AND WHAT CAUTIONS EXIST TO ENSURE THAT DISPARITIES ARE NOT WIDENED?
RESPONSE: A guiding principle should be to “meet patients where they are.” There will be wide variation of patients’ ability to generate data, as well as the amount of technology available to patients. Policies, standards, certification criteria, and performance measures regarding PGHD should accommodate patients from low-tech to high-tech, as opposed to assuming only one particular type of patient (such as the savvy, highly educated and networked patient). Some patients will have access to smart phones, and patient care devices that can easily transmit data according to standards (Continua Health Alliance, etc.). Some will only have pencil and paper. Others may not have access to much technology – e.g., may not have access to a web-based patient portal — but can at least send text messages.
SUMMARY: Strive for wide adoption and lowest barriers to entry, by evaluating and embracing a combination of data entry and viewing technologies that are most commonly used by patients.
OTHER CONSIDERATION – WHO IS RESPONSIBLE FOR OWNING AND VIEWING WHAT DATA?
As more PGHD as well as HIE data become available, we believe that the HIT PC in particular and the industry in general need to address concerns about responsibility and liability when dealing with an increasing amount of available information given the high workloads and demands on clinicians’ time. A clinician may ask: “What am I responsible to look at, just because it exists?” Additional PGHD is useful, but clinicians may not have time to review it all. Whether PHRs, other PGHD, HIEs, or other sources make much more information available, we believe there should be ways to classify the information as something that was requested by the clinician (e.g., patients to monitor and record their blood pressure, weight, pain, etc.) vs. unsolicited PGHD that may or may not be helpful. Are there best practices and testimony that could inform policy here? Clearly, what a clinician should review must lie somewhere between “all data that exists anywhere on the patient” vs. “nothing more than what I gather myself.” In current practice, data that is incorporated into a paper chart or an EHR was first reviewed and commented upon by the clinician. If data are being tracked, someone needs to be designated as having primary responsibility for the data (maintaining, validating, viewing, etc.), and policies can help clarify who is responsible for what. There should not be an expectation that all data will simply flow into an EHR, if no one has responsibility for reviewing it.
SUMMARY: Define clear purposes, expectations and responsibilities for the review and use PGHD.
Sincerely, on behalf of Siemens Health Services
David Tao, D.Sc., Senior Key Expert, Interoperability Champion
Jodi Kodish-Wachs, MD, FAAPMR, Physician Consultant
Theresa McGillvray-Dodd, Marketing Specialist
Margaret Meadow, Director, Government and Industry Affairs
GENERAL COMMENTS
Siemens Healthcare Health Services (Siemens HS) thanks the HIT PC and HIT SC for the opportunity to comment on incorporation of patient-generated data for stage 3 meaningful use. Siemens HS is the information technology (IT) business unit of Siemens Healthcare, with worldwide headquarters in Malvern, PA., employing about 5,000 individuals worldwide. We commend the committees on their support of patient engagement for the betterment of patient health as well as a more accountable and coordinated health system.
Our responses to the ten specific questions are included below. In addition, in “Other Consideration” at the end, we have added a comment on the important policy issue of responsibility, that was not asked.
Health Dialog believes that the incorporation of patient-generated data in an EHR will facilitate higher quality shared decision making in healthcare, and appreciates the opportunity to comment on this important work by the federal advisory committees. Health Dialog is a leading provider of healthcare analytics and decision support. Company offerings include health coaching for medical decisions, chronic conditions, and wellness; population analytic solutions; and consulting services.
Useful Measures of Patient-Generated Data
Only through patient-generated data, incorporated in the electronic health record, can the larger goals of meaningful use and healthcare reform be achieved. However, most patient medical records exist in multiple and fragmented sources, making the patient, or outreach resources such as a care coordinator, the only source of continuum of care information. Patient care plans should be personalized, based on information obtained directly from the patient, to reflect the individual’s disease trajectory, values, barriers to behavior change, goals and range of therapies that shape their total experience. In the current technology environment, maximizing the collection of data in a structured format will enable providers to improve the patient experience based on quantified, aggregated results.
The following measures can be incorporated, by clinicians, as structured data into an EHR based on patient narratives or surveys:
Disease Trajectory – Because providers often lack longitudinal, symptomatic or other specialist-documented data, patients are often the source of information regarding the stage of their disease. Classifying patients into a disease trajectory enables clinicians to provide them appropriate guidance and education based on their disease progression. Disease trajectory can be segmented into simple categories such as onset, early progressive, late progressive, pre-operative, surgery or recovery. These categorizations can be calculated or estimated by asking the patient 1) when the onset began 2) how much the symptoms are limiting their ability to perform basic physical tasks 3) what treatments they are currently receiving and 4) what treatments they are considering. Other information such as pain scales and activities of daily living can also help to classify patients into disease trajectories.
Barriers – Many patient describe significant barriers to following the orders of their physicians or to achieving care plan goals. The barriers to achieving an outcome can be coded into categories in the EHR that help the clinician to understand more complex needs, the appropriate referrals, or other resource assistance their patients need to achieve better health. Examples of categories of barriers include transportation, financial, language, stress, social support and cognitive impairment.
Pre and Post Intent – In order to measure the effectiveness of patient education, coaching or care coordination activities, soliciting the impact of these activities can be accomplished by simply categorizing the pre and post intent. This might simply be accomplished through categories such as “considering test” or “not considering test” to indicate scheduled and completed.
Many clinicians do try to capture this type of patient-generated data in their text notes or other paper documents, but often EHRs do not collect this data in a structured format. As a start, these simple categories will result in richer, measurable data that can be beneficial in the near term for a more patient-focused approach to care.
The Kaiser Permanente Medical Care Program is the largest private integrated healthcare delivery system in the U.S., delivering health care to approximately 8.9 million members in nine states and the District of Columbia. As part of our commitment to high quality care, Kaiser Permanente has made a significant investment in a program-wide Electronic Health Record (“EHR”) system. Our comments are based on both our long experience with EHR technology as well as our ongoing work to achieve the goals of meaningful use within our organization.
We are concerned about the increasingly prescriptive nature of objectives and measures especially because of the potential for interference with the provider/patient relationship and appropriate clinical decision-making. For example, we recommend more flexible requirements for clinical decision support systems to grant providers broad discretion about when to use such systems based on appropriate treatment choices regarding individual patients. We favor regulations allowing providers to demonstrate meaningful use of clinical decision support in various ways, depending on practice characteristics and patient needs. In addition, overly prescriptive objectives and measures may conflict with goals to encourage and leverage organizational efficiencies.
We believe that Stage 3 standards under discussion for public health reporting objectives and measures do not reflect the actual state of readiness for both public health agencies and electronic reporting technology. Public health reporting via electronic means is still not common practice; moreover, public health agencies are outside the scope of meaningful use. For example, most immunization registries currently support very limited exchange formats and it is highly unlikely that they will have established the technological capability required to handle on-going submission of electronic data by Stage 3.
We understand the need to promote greater patient engagement, but we are concerned that some of the capabilities under consideration call for and assume a level of sophistication that consumers and the market have not achieved. For instance, the technology for enabling patient-initiated successful transmission of health information from an EHR is not robust – the number of technological and operational barriers to patient-directed exchange as a component of the patient online tool is still too high. We recommend instead that related objectives and measures should focus on encouraging a broader array of options that enable testing and use of alternative approaches.
More generally, we urge ONC to consider the timing required to bring technological capabilities to market. A technological capability should be in place before standards and objectives are developed to measure its use. Vendors generally need a minimum of 18 months to develop, produce and market technology – and then providers need additional time to procure, implement, and use new EHR functionality.
Thank you for the opportunity to comment.
PGHD is, in my opinion, some of the most important information that can be kept regarding a patient’s life in general – providers rarely have the full picture of everything that can affect a diagnosis, and even just seemingly insignificant factors that would otherwise be overlooked can be given the attention due when in the right hands.
It will inevitably be a great challenge for both patients and providers to learn to filter and capture the critical elements of their own PGHD and to disregard the “noise,” but it is a challenge that our society is up to, I believe. We have learned – for the most part – to deal with it in many other realms of our society today ever since the advent of the internet, and I’m convinced that it is an ability that will become all the more necessary in the future as technology progresses. As for what kind of tech could help us in our data management today? Well, I unfortunately don’t have an answer for that. I think many providers already have a very difficult time managing data – not just from their own records but integrating with other providers for a more holistic picture – that adding PGHD into the mix is clearly going to be difficult. But in my mind it is an absolutely necessary adaptation to be made.
Thank you for this great article and for the chance to voice our opinion. As a student I just start to learn more about this topic.
How can collection of PGHD address health disparities and what cautions exist to ensure that disparities don’t widen?
With the support of computer technology and software a matching of the data could be ensured. This way health disparities don’t widen even more. In addition regular controls should occur.
It is our opinion that PGHD is the most important information in the EHR from the patient point of view. The question becomes what type of product needs to developed: open, closed or a hybrid of both. It is our opinion that all EHR development must always be patient centered, so that all people can connect their personal information to the EHR.
I think that a nationwide platform holding the PGHD would make it a lot easier for both patients and doctors.
We have been using patient entered data via tablet pcs for years
http://thebreastcancersurgeon.org/hughesriskappsriskmodule/
Patients have more onformatiothan most EHRs, nad tablet generated surveys ask every question, while MDs get bored and stop asking before all data is available.
The best is pt entered data that is then enhanced with Clnician data and what data exists in teh EHR. This is our goal
I am currently working on a Grad Paper on this subject for Kaiser and OHSU. My finding to data illustrated the need to incorporate PGHD into Patient Panel Surveillance to provide a more complete view of the patients health.
- Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form? Any structure that we can put on this data will make it easier for the data to be utilized. I understand HL7 is working on this issue
Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR? – EHR are episodic in nature so are EHRs, ODL or Observations of Daily Living are more of a contiguous steam. I see this as a EHR design Problem. One solution is that the ODL are ingested into the EHR as a Vital.
For which health issues is it clear that patients and families are the authoritative source? –There observation of pain, depression, smoking..
How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive? — as we move away from the current payment model the provider will naturally migrate to a wellness model, PGHD has been proven to lead to better outcomes for chronic conditions such as CHF.
What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination? – many, we must got the patients input when they are outside of the providers office inorder to provider better more patient centric care. He is a quote from Dr John Kitzhaber Gov, of OR on a costly episode that could have been interviened with better care management:
We are only beginning to utilize surveillance in our everyday health/healthcare as it involves the patient and providing meaningful personal interventions. During keynote at the 2010 Oregon HIMSS chapter’s annual meeting, Oregon Governor, John Kitzhaber, MD told a story of an elderly woman with congestive heart failure living in a sweltering hot home state that, under our current medical system (CMS) that we have in United States today, Medicare will pay for the ambulance to get here to the an Emergency Room, $50,000 of care when she is admitted to the hospital and thousands of dollars in ongoing care once she is released but will not pay for a $200 air conditioner which is all she needs to not have this costly episode . Dr Kitzhaber story illustrates that something as simple as an ambient thermometer that communicates via WIFI or Booth could be part of a patient surveillance that could save lives and payers cost.
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The following are a few excepts from my research that may be helpful.
excerpts:
In order to close the loop and provide a more complete population surveillance including medication non-adherence, and depression in the patient-centric environment, it is necessary to include patient-reported/collected data or Patient Generated Health Data (PGHD) and ODL (Observations of Daily Living
Currently, Population Surveillance is primary used to measure the patient population’s health by clinical providers within clinical settings. With the advent of the smartphone and smart wireless devices we are beginning to see patient surveillance moving outside of the walls of the providers office and without the direct oversight of a clinician.
Tom James, MD and Michael Fine, MD stated in their research of utilizing Patient-reported data along with claims data that, “Data derived from Healthcare Effectiveness Data and Information Set (HEDIS) measures do not accurately predict which individuals will become frequent users of health care resources. Instead, health care plans must incorporate regular and careful monitoring of symptoms through the use of patient-reported outcomes as part of an overall asthma-management strategy to identify patients with disease that remains uncontrolled” .
PROMIS (Patient-Reported Outcomes Measurement Information System) system overview states that clinical lab test and clinical measurements have very little relevance on the chronically ill patients everyday life .
Currently, there are no existing vocabularies that represent specific patient-reported nomenclature and ontology.
PGHD is incredibly important for the patient. Consider it from just a technological stanpoint. Since almost all medical records are moving to EHR or electronic health records, and our computers continually get faster and can store more data, in my opinion, why not gather all the data possible? Patient input would be incredibly relavent to the diagnosis that a doctor may give. I’m still trying to get more information on the Incentives for EHR on Stage 3. As a member of a practice, my 5 doctor’s would be very interested.
think that a nationwide platform holding the PGHD would make it a lot easier for both patients and doctors.
It is our opinion that PGHD is the most important information in the EHR from the patient point of view. The question becomes what type of product needs to developed: open, closed or a hybrid of both.
Collection of information can be obtained by a dynamic personal health record linked to the patient history (under patient entry) that includes health literacy tool ( survey), patient activation measure ( tool), pain management index, mental health status check ( survey or tool), symptom severity index, medication efficacy index ( plus adverse . side effects measure, SES ( Socio-Economic- Status) index, community health resource assessment, caregiver provider status, and timeline changes index for the above on quarterly or semiannual basis?). This information would necessarily be both structured and free text based and then screened by computer algorithm and flagged for staff attention as needed for further clarification, verification, etc. This information is melded with known clinical condition and symptoms of patient I( if already in system) or flagged for recall, new patient visit, followup labs, etc.
Health issues that are authoritatively sourced to the patient or family?
1. These could include genetic tests, family history that are positive for known conditions. Conditions that precipitated health problems congenital disorders, environmental contamination, depression, anxiety, PTSS, concussion history, or that the family has prior knowledge of that may not have been provided, etc. Some other things that come to mind are drug and alcohol abuse, physical or sexual abuse, eating disorders, poor hygience, behavioral disorders triggered by known stressors. This is a tough question since much of the information may be guarded or suppressed as part of the family dynamic. Perhaps a test or tool that indicates predisposition / tendencies that indicate problematic concerns can be administered. However, a home visit at the least and more preferably a formal intake would be advised.
2. The other side of this question could be what health issues could be sourced with appropriate interventions and support so that the family or patient could self manage after treatment, intervention, education, and support has been provided. Chronic conditions that might be proactively managed would include diabetes, asthma, arthritis, etc provided patient and family were adequately aware of when to seek medical guidance ( red flags,etc).
How can collection of PGHD address health disparities and what cautions exist to ensure that disparities don’t widen?
1. Computer algorithms could be developed that check PGHD against the existing patient EHR that automatically flag alerts similar to medication alerts when combined with other medication, homeopathic remedies, etc. As part of the of the PGHD perhaps there is a weighting of accumulated data that triggers a response when entered into the EHR. I envision a program similar to Watson that collects and processes all of the data input from the PGHD and EHR and then alerts a care provider team member with known conflicting information, potential adverse events or side effects, or indications for specific followup test / provider notification.
very good…………chuot khong day