ehealth Policy Paper
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 GLOSSARY DATA GOVERNANCE: The exercise of decision-making and authority on matters relating to data and information. i DATA STEWARDSHIP: Responsibility for the appropriate management and protection of the data contained in an electronic medical record or electronic health record. ii E-HEALTH: The provision of health care services supported by modern electronic information management tools, processes and resources. iii ELECTRONIC HEALTH RECORD: A compilation of core health data submitted by various health care providers and organizations, accessible by numerous authorized parties from a number of points of care, possibly even from different jurisdictions. ii ELECTRONIC MEDICAL RECORD (EMR): An electronic version of the paper record that doctors have traditionally maintained for their patients and which is typically only accessible within the facility or office that controls it. ii LOCKBOX: A security feature that allows access to a patient's personal health information, or portions thereof, to be restricted to certain users at the specific request of the patient. Often used interchangeably with the concept of masking. ii MASKING: concealing of a patient s personal health information, or portions thereof, at the specific request of the patient in order to limit/control the information disclosed to other providers. Often used interchangeably with lockbox. ii PERSONAL HEALTH RECORD: Also referred to as patient health record. An electronic record typically created and maintained by the patient, sometimes using a third-party online service. Unlike EMRs/EHRs, which are typically created and maintained by a health care professional or facility, the term PHR commonly refers to a compilation of information personally gathered and maintained by the patient regarding his/her health. The patient controls access and information inputted into the PHR. ii i Thomas G. The DGI data governance framework. Orlando, FL: The Data Governance Institute; 2012. Available from: http://datagovernance.com/dgi_framework.pdf. Accessed: 2013 Aug 20. ii Canadian Medical Protective Association. Electronic records handbook: implementing and using electronic medical records (EMRs) and electronic health records (EHRs). Ottawa, ON: Canadian Medical Protective Association; 2009. Available from: http://www.cmpa-acpm.ca/cmpapd04/docs/submissions_papers/pdf/com_electronic_records_handbooke.pdf. Accessed: 2013 Aug 20 iii Alberta. College of Physicians & Surgeons. CPSA vision for ehealth. Edmonton, AB: College of Physicians and Surgeons of Alberta; 2012 Sep. Available from: http://www.cpsa.ab.ca/libraries/information_for_physicians/vision_for_ehealth.pdf. Accessed: 2013 Aug 20. Page 1 of 23
26 27 SECONDARY USE: The use of personal health information for purposes other than the provision of health care, for example, for research or health system planning. ii Page 2 of 23
28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 EXECUTIVE SUMMARY The Ontario government has been working on a provincial strategy for an ehealth system for over a decade. Such a system has the potential to improve care for the patient by linking databases, records and information from across the entire care continuum, to help ensure more effective, efficient and seamless exchange of information. While the development of an electronic health record (EHR) has been a high priority initiative for many years, and the Government s 2015 goal for system establishment remains, there is still much progress to be made. Unfortunately, there has been minimal system engagement with health care providers. Physicians and other health care providers are best suited to support strategy development and implementation given their unique and critical role in the provision of care. Physicians should be considered leaders in the ehealth environment, and involving them in the decision making process is critical. As such, on behalf of Ontario s physicians, the Ontario Medical Association (OMA) has a key role to play in the development of an ehealth system strategy. The OMA is supportive of the movement towards ehealth use. Wise utilization of ehealth technology can help empower the physician-patient relationship; it can improve access, quality, and safety of care. However, the effective rollout of an ehealth system must be supportive of physicians. Physicians must be provided with the tools and resources to become ehealth experts. Health care provision is laden with complex situations that involve confidentiality, privacy, and ethical decisions to be made. The introduction of an electronic system must not undermine any of the core values that underpin the trust inherent in the doctor-patient relationship and should be put in place to improve upon the current paper system. It is fundamental that the open exchange of information and trust that currently exists between patients and the physicians be maintained; this cannot be compromised with the introduction of an electronic system. In addition, security and access issues must not impede proper patient care. They must be non-disruptive; and the system, with the proper safeguards in place, must be easily accessible. The proper functioning of an ehealth system is dependent on physician participation and therefore physicians must be partners in governance and any decision making committees for system success. Furthermore, in order for an effective ehealth system to function, integration between systems is essential. The true benefit of the EHR cannot be realized without the integration of various electronic systems. It is important that a framework/strategy be developed for the integration of current and future electronic systems, including electronic medical records (EMRs) held in independent physician offices/hospitals, laboratory systems, medication management systems, as well as Independent Health Facilities (IHFs), Community Based Specialty Clinics (CBSCs), Public Health Units, and many more. In addition to the importance of the integration of electronic systems, the proper safeguards must be in place to ensure that physicians have uninterrupted access to records. This will help prevent risks to patient care. The development of Ontario s ehealth strategy must ensure system integration remain a priority. Page 3 of 23
65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 This paper will review the history of ehealth in Ontario, and will provide recommendations for ongoing strategy development. INTRODUCTION ehealth relates to the provision of health care services supported by the use of modern electronic information management tools, processes and resources. 1 The Electronic Health Record (EHR) brings together information registered with health care providers and the provincial health care plan. The EHR should be viewed as a network of linked records and information contributed by multiple health professionals involved in patient care. Eventually, EHRs will include data from hospital information systems, community care clinics and other providers involved in the patient s care 2. EHRs indicate system integration and interoperability, and extend beyond individual electronic medical record (EMR) systems which are housed in independent offices. It is important to note that the EHR does not exist as a single entity. Rather, the EHR includes the myriad of individual systems (such as EMRs) and linked repositories containing patient information. An EHR exists at the system level, and ideally would be a compilation of core health data from multiple sources (eg. physicians, physiotherapists, pharmacists, laboratories), which would include the EMR as one component of the Record. It is comprised of different records submitted by health care providers and organizations and accessible by authorized individuals from a number of places of care, and occasionally from different jurisdictions, for the purpose of delivering health care. Interprofessional documentation is expected to increase over time. The OMA began its foundational ehealth work with a focus on EMRs. Considerable progress has been made in this area, and the OMA is now moving forward and focusing on the broader electronic environment in addition to advancing the EMR work. By 2015, it is anticipated that the majority of Ontario physicians will be practicing in an ehealth environment. The OMA supports ehealth initiatives that enable physicians and patients to provide and receive quality care. There are important policy questions that should be considered by decision makers as the provincial ehealth framework is developed in Ontario. The OMA s role is to represent and advocate for patients and physicians interests in planning, developing and implementation of Ontario s ehealth Strategy, and therefore, the OMA has a key role to play in the strategy development process. This aligns with the work that began in 2008 with the development of the Physician IT Strategy. As part of this work, some of the following principles were developed. These principles should be used to frame the discussion around the physician s role in ehealth: 1. Health IT must support and improve patient care. 2. The integrity of the physician-patient relationship must be preserved in the ehealth environment. 3. Privacy and security of health information must be protected. 4. Professional and clinical autonomy must be preserved. 5. Physicians must be supported in the exercise of their rights and the discharge of their obligations. 6. ehealth is a strategic investment that must be available to all physicians. Page 4 of 23
105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 7. Physicians must have accountable-representation with direct input into the planning development and implementation of Ontario s ehealth environment. 8. Support and incentives are necessary for adoption and sustainability. 9. ehealth must evolve through needs based innovation. 10. The government must continue to fund physician ehealth implementation costs to expedite implementation and obtain greater benefits. 11. Healthcare IT applications and systems must align with physician usability and workflow; training requirements must be minimized and efficiencies should be gained through the use of ehealth. Physicians must be equal partners at the decision making table; it is critical that the physician voice and perspective be a key contributor to this process. The physician-patient relationship represents the cornerstone of the health care system, and therefore physicians must provide insight into the ehealth decision making process. While it is important that other health professionals be engaged in ehealth strategy development, it is expected that physicians will be of the most active users of the system, in addition to being those responsible for the collection of the majority of the information. Therefore, physicians should participate in all stages of strategy and system development. Health care provision is laden with complex situations that involve confidentiality, privacy, and ethical decisions to be made. The introduction of an electronic system must not undermine any of the core values that underpin the trust inherent in the doctor-patient relationship and should be put in place to improve upon the current paper system. It is fundamental that the open exchange of information and trust that currently exists between patients and the physicians be maintained; this cannot be compromised with the introduction of an electronic system. In addition, security and access issues must not impede proper patient care. They must be non-disruptive; and the system, with the proper safeguards in place, must be easily accessible. The proper functioning of an ehealth system is dependent on physician participation and therefore physicians must be partners in governance and any decision making committees for system success. The OMA believes that ehealth has the ability to transform patient care and enhance the quality of health information, statistics and research if properly implemented. Successful implementation is dependent on a provider-oriented strategy. Such a strategy will enable physicians and other providers to provide better care for their patients within offices, clinics and local institutions. It will also enable providers to be more productive and efficient. The OMA strategy respects the professional independence and choice of Ontario s physicians, and recognizes that ehealth must deliver true value to physicians and patients, without imposing a security or financial risk to the system, or making practice workflow more onerous. EHEALTH CLIMATE ehealth Ontario was established by the provincial government in September 2008 as an independent agency of the Ontario Ministry of Health and Long Term Care (MOHLTC). In 2009, the MOHLTC and ehealth Ontario signed a Memorandum of Understanding tasking ehealth Ontario with providing a single harmonized coherent province-wide ehealth strategy and aligning the strategy through multiple points of accountability. The mandate of ehealth Ontario includes the integration of all provincially funded health care system information initiatives that support Page 5 of 23
147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 clinicians and patient care delivery, that are actually or potentially province-wide in scope. ehealth Ontario is responsible for the delivery of an EHR, with decision making authority for the EHR lying with the MOHLTC. At the current time, the 2015 provincial goal of having a functional Electronic Health Record remains. 3 As such, the OMA must be proactive in the development of a Physician strategy. OntarioMD (OMD) is a wholly-owned subsidiary of the OMA that provides physicians with easy access to information and resources to help them transition from paper records to EMRs to improve the delivery of patient care and practice efficiency. OMD was established to manage the Physician IT Program established by the MOHLTC and the OMA. OMD manages the EMR Adoption Program, funded by ehealth Ontario, which assists physicians with the adoption and implementation of funding eligible EMR offerings. OMD s vision is to promote adoption and use of EMRs to ensure the system s investment reaches its utmost potential. The College of Physicians and Surgeons of Ontario (CPSO) has recently released an ehealth Statement outlining the role of the College, physicians, and other health system stakeholders in the ehealth environment. Specifically, the CPSO encourages physicians to commit to ehealth learning and ehealth literacy, and using ehealth to benefit patients. It is important to note that this is a statement as opposed to a policy; it does not mandate physicians adoption of any technology and it reflects the CPSO s commitment to ensure the effective progress of ehealth development and implementation. 4 The MOHLTC has recently released Bill 78, An Act to amend certain acts with respect to electronic health records (ephipa) 5. This Bill seeks to formalize many issues that arise in the ehealth environment. ephipa is expected to go through the legislative process in the fall of 2013. A. EHR Scope Information required for patient care should be accessible through the EHR. This must include the bidirectional flow of data. However, in order to have a seamless, efficient, and effective rollout of EHRs, a phased approach to implementation, beginning with key providers (physicians, pharmacists, nurse practitioners, labs, hospitals etc) and cornerstone repositories is recommended. The system should be accessible and should rely on the existing professional accountability of regulated health professionals for appropriate use. In our current system, access to patient information is based upon a fundamental respect for privacy; only the information necessary for the purpose should be shared or accessed. This is done with either express or implied consent and in accordance with professional accountability for one s actions. The same principles must underpin the EHR strategy. While the eventual goal is to have all healthcare providers as participants in the electronic system, physicians must be enabled through this process, and participation must remain voluntary until a comprehensive strategy is in place that will add value and improved quality to the care process. Mandating physicians to adopt electronic practices prior to the development of a comprehensive electronic health care system could pose obstacles to the success of a provincial electronic system, as physician support is critical. Recommendation: Physician participation in the EHR must remain voluntary until a comprehensive strategy and a functional system is in place. Page 6 of 23
188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 Physicians must be provided with the tools and resources to become proficient in ehealth in order to ensure patients receive the best quality care. GOVERNANCE Governance deals with the mechanisms that are used to guide, steer or regulate the course of an organization or system. 6 ehealth is broad and diverse and includes many players, and therefore no single entity should be entirely responsible for its development, control, and ownership of data and the system. The ehealth field includes the public, or recipients of healthcare delivery, physicians and their clinical practices, policy and information management processes, as well as technology required to enable the field. 1 At the present time, there is no formal governance structure responsible for the oversight of Ontario s ehealth agenda. As a result, the approach to decision making has been fragmented. The development of an effective governance model will require a framework of policies that establish the rules of engagement around the use of the EHR, and the obligations and accountabilities of those participating. Such a governance model will be subject to applicable laws. The MOHLTC must discharge its strategy and policy duties in a clear and transparent manner. Because the health care system is in the early stages of developing this framework, decision makers must refrain from being over-prescriptive in the initial strategy, since key questions about governance, control of information, and data quality/integrity remain unanswered. Ontario lags behind other jurisdictions in ehealth integration. Therefore, a long term view enabling the integration of different systems is required. It is imprudent for the MOHLTC to manage all parts of this system, particularly interactions between physicians and their patients; providers must be involved in this process. As such, the OMA has a critical role to play in the development of a governance framework. In addition to the need for an ehealth system governance strategy, issues related to data governance and data stewardship have yet to be solved around the data within the EHR. Data governance can be defined as the exercise of decision-making and authority on matters relating to data and information. 7 There is significant value in ensuring that all stakeholders are aware of and understand the respective obligations of participants so that these varying obligations can be anticipated in advance and incorporated into an effective data governance framework. These obligations should be delineated in a data sharing or information management agreement that will govern physicians and other health care providers use of the EHR managed by the MOHLTC and/or ehealth Ontario. In addition, a governance framework must address questions around secondary uses of information. Data issues as identified by requests for information and indicators in Health Links and Ontario s Quality Improvement Plans (QIPs) are two relevant examples of initiatives currently underway in Ontario requiring the disclosure of data for secondary use purposes. In order to meet the needs of both the physicians and the government s initiatives, a framework for dealing with data requests and management issues is essential. The goal of this framework should be to balance system level accountability with patient confidentiality. As data stewards, physicians play a critical role in the development of this framework. To this end, the OMA, together with the College of Physicians and Surgeons of Ontario (CPSO), the Canadian Medical Protective Association (CMPA) and other stakeholders should develop a data governance strategy to support physicians on such matters. The Page 7 of 23
230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 development of this strategy should also support the implementation work which must occur. This work should include the OMA. Recommendation: The OMA s Data Governance Working Group should include other health system stakeholders to identify and make recommendations to Government on data governance, access and secondary use of data. The developed data governance framework must balance the need for data with the confidentiality/trust inherent in the physician-patient relationship. A. Electronic Medical Records: A Fundamental Building Block An electronic medical record (EMR) is the electronic version of the paper record that doctors have traditionally maintained for their patients and which is typically only accessible within the facility or office that controls it. 8 Certified EMR products provide healthcare providers with a tool to manage their patient population and provide continuity of care. In addition, EMRs offer providers with information management and decision-support tools, and will ultimately integrate with the provincial EHR. Physicians in Ontario have made significant strides in the uptake of EMRs. This has been a critical step in the development of ehealth in Ontario. At the present time, approximately 70% of primary care physicians are using EMRs, with the goal of 85% uptake by 2014. EMR data captures the clinical encounter between the physician and the patient, as well as other important personal health information such as family and social history, and therefore, the data housed within physicians EMRs is the cornerstone of the system-wide EHR. This data serves many purposes including but not limited to the provision of patient care, analysis at a patient population or practice level, as well as on a system level. While this data is essential to the system-wide EHR, it is essential that the fundamental relationship between physician and patient be respected and maintained. While the majority of EMR users are primary care providers, the number of specialists using EMRs is increasing. There is a variation in specialist needs, which should be considered as enrolment increases and progress is made by vendors. The OMA should be involved in this work. As previously discussed in the section on data governance, there is currently no clear framework governing what information should and should not flow from a physician s EMR to the systemwide EHR. In addition, there are no provincial data standards for coding in an EMR, and thus it is difficult to extract information for reporting at a provincial level. There are currently initiatives underway, such as those led by the Canadian Institute for Health Information (CIHI), and Canadian Primary Care Sentinel Surveillance Network (CPCSSN), which collect data from individual EMRs to perform health data analysis at the practice level. As outlined in the section on governance, there is no framework governing the flow of data. To this end, individual physicians are making decisions regarding data sharing. For this reason, it is important that the expectations of physicians with respect to patient data be clarified. This is in the best interest of both the physician and the patient. The OMA together with OMD are at the forefront of this process, and should take the lead in the development of a data stewardship framework, to guide physicians Page 8 of 23
271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 through this process. This work must consider the unique practice situations of physicians in different fields of medicine as the framework is developed. As the health care system is evolving with a greater focus on quality improvement and benchmarking, and as system level expectations of physicians are increasing, it is critical that EMRs evolve. EMRs must be developed to enable quality improvement and benchmarking as functions within the systems. Such capability should include practice management and audit functions, as well as patient profiling. Recommendations: Various specialities needs should be considered in specifications of EMRs. EMRs should evolve to incorporate quality improvement and benchmarking functions within the systems. CONSENT MANAGEMENT When considering the implementation of the ehealth agenda and consent management specifically, it is critical that the system is practical and clear for physicians to use, while at the same time protects patient confidentiality and permits patients to exercise their existing legal rights. It is crucial that the patient-physician relationship be preserved. One of the key challenges emerging in ehealth is the need to educate Ontario s physicians, other health care providers, and Ontario s public about the changing environment and their roles within it. Jurisdictional research demonstrates that the majority of patients accept having their information flow within the system to support the delivery of health care services. Since it is anticipated that only a small minority will choose to not participate, an opt-out system for patient participation is recommended. This mirrors the current paper system. Necessary information will be shared as appropriate within the circle of care, and information will be withheld only upon express request. The current design of the system is such that should a patient opt out of the EHR, no patient data would be included. From a clinical perspective, physicians must be advised if clinical data is blocked. Dangerous decisions can be made if physicians are unaware of deficiencies in the patient record. While patients should have the right to withhold information related to the healthcare encounter from the system, the OMA believes that basic patient demographic information should not be masked in the system. This would allow for the creation of a unique identifier for all patients within the EHR. To this end, PHIPA should be amended so that basic identifiers are not defined as personal health information when they are used to identify an individual (as opposed to linking it with other personal health information). This would allow authorized users within the EHR to confirm that the patient exists in the system, but respect patients rights to confidentiality. In addition, from a system perspective, it will make managing patient identification more effective. Recommendation: PHIPA should be amended so that demographic information is not defined as personal health information when used solely to identify a patient to allow the creation of a unique identifier for all patients in the EHR. A. Information Masking Page 9 of 23
311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 Information Masking refers to the blocking of a patient s personal health information (or portions of the record) at the request of the patient in order to limit or control the information that is disclosed to other health care providers. 8 Similarly, a lockbox (not a defined term under PHIPA) is a security feature allowing access to a patient s personal health information, or portions of, to be restricted to certain users at the specific request of the patient. 8 Current legislation enables patients to create a lockbox and mask information within the record. While the OMA believes that it is in the patient s best interest to have their information shared across providers within their circle of care, the OMA understands the need to keep with legislation and provide patients the option of masking information or creating a lockbox within the EHR. Also consistent with legislation, physicians generally do not need a patient's express consent to include his or her health information in an EMR/EHR, or to share patient information with other health care providers for the purpose of providing treatment. Physicians can rely on a patient's implied consent to share information within the circle of care, which includes those health care professionals who need to know the information for the purpose of providing care. This is done for the purpose of providing the best quality care. While the OMA understands that some patients may opt to mask information, current technology poses a barrier to consistently addressing this process. As the current system stands, small field level masking may not be reasonably achievable in most systems, which means that the patient cannot choose to mask only certain elements of the patient encounter. To this end, the patient must choose to either include or mask the entire record. This can have consequences on proper patient care. In addition, patients who wish to mask information are often unaware of the potential implications of this choice, and how detrimental it can be to the quality of care they ultimately receive. It is important to consider that information masking requests occur in exceptional circumstances, and thus the system should be mindful about the need to balance resources. The OMA believes that the physician has a role to play in this process in assisting patients to understand the consequences of masking; however, it is unreasonable to require physicians to provide education on government legislation and policy. It is critical that the MOHLTC take responsibility for informing and educating Ontario s public about masking. As part of this education, the public must be informed of the potential implications of the decision to mask some/all information. It is imperative that the government take responsibility for ensuring the public is aware of this. Physicians should be able to discuss general information related to masking to patients if called upon to do so and therefore, adequate education and support materials must be provided to physicians so that they understand and can inform patients about masking. In addition, physicians must be provided with the skills to ensure that their professional and ethical obligations are maintained should a patient request that information be masked. 8 It is expected that the role of the physician in this process will evolve as technology advances. The MOHLTC must turn its attention to questions around whether there are circumstances in which a physician should be able to access masked information without patient consent and, if so, how each instance should be handled. The OMA should collaborate with the CPSO and the MOHLTC in determining this policy. Recommendations: The MOHLTC has a duty to inform the public about masking and the potential consequences of masking on patient care. Page 10 of 23