1. WHY ARE ELECTRONIC MEDICAL RECORDS IMPORTANT FOR PERSONALIZED MEDICINE?

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1 THE ELECTRONIC MEDICAL RECORD: A CRITICAL ISSUE IN PERSONALIZED MEDICINE 1. WHY ARE ELECTRONIC MEDICAL RECORDS IMPORTANT FOR PERSONALIZED MEDICINE? As initially configured, electronic medical records (EMRs) were largely about portability - the ability to transmit patient information instantaneously between physicians, hospitals and the like. This was a significant transition from the inefficient paper chase. But innovation is speed and the past decade has seen massive changes in information technologies, in medical technologies and in molecular medicine, including genomics. The combined result is that personalized medicine has become more than just a futuristic concept. Personalized medicine, defined as diagnostic, prognostic, and therapeutic strategies precisely tailored to each patient s requirements (Mirnezami et al.), sometimes also called precision or systems medicine, uses large data sets to help in diagnosis and therapy. Currently there are examples in cancer, in orphan diseases and in pharmacogenomics where personalized medicine has already taken hold. In its simplest and current form (albeit where implemented), the EMR of 2013 contains the medical history of a patient that is simultaneously available to, for example, the patient, the patient s family physician and a specialist in a different hospital. Going forward, the tsunami of data (personal, clinical, research, environmental) that is housed in so many different places must be organized in a sophisticated and interactive manner. This will lead to the possibility of understanding disease and targeting therapies (including prevention). Then we will be able to more completely realize the potential of personalized medicine where the patient gets the treatment that is predictive, personalized, preventive and participatory as coined by Leroy Hood. For that reason, sophisticated EMRs will be required if we are to approach personalized medicine in the most effective and efficient manner for the benefit of the patient, the health care system and research. The OPMN performed a consensus analysis of three international reports on strategies for personalized medicine (from the U.S., the U.K. and the EU) as concerns their main themes and recommendations. Amongst these was the recognition that there is an explosion of molecular data that provides opportunities to improve individual health outcomes, but that [t]here are currently no systemic means of translating inventions to the clinic, and that we will need to use large reference databases for health benefits on a day-to-day basis. Large reference databases need to be built. Most importantly, EMRs will be a critical tool to enable translation to the clinic, and to facilitate the use of such large reference databases. Collecting the information, and learning what to do with it, are the key tasks we face. As pointed out by Francis Collins, Director of the National Institutes of Health in the US, We are

2 living in an awkward interval when our ability to capture the information often exceeds our ability to know what to do with it. It is imperative that we collect and store our data in forms that will be useable when that time comes, while we develop efficient and effective ways to use it. The EMR is the critical tool throughout this process. How to build the EMR for the future? 2. WHAT IS NEEDED? PATIENT EMR FOR PERSONALIZED MEDICINE We need an EMR that contains or can contain billions of data points with respect to patients : 1) Patient and Family History 2) Chemistry, Haematology 3) Complete Genome Sequence 4) Metabolomics 5) Proteomics 6) Immune Status (Inflasome) 7) Medical Imaging/Radiology 8) Environmental exposures (Environome) This is not a static record but rather all data should be accumulated in real time. CONNECTIVITY AND INTERPRETATION It is clear that this patient record must be simultaneously available to patients and their caregivers over multiple sites. It is also clear that issues of privacy must be taken into account as the data becomes readily accessible across sites. There seems little doubt that such privacy can readily be attained by allowing access through appropriate encryption, screening of requests and password protection. What is most exciting going forward is the ability to use such an extensive patient record to interrogate large clinical and research databases that will: Aid in stratification, diagnosis and health planning Add to the collected body of knowledge leading the goal of true personalized medicine For example, without too much investment, algorithms could be applied to the electronic record (containing personal and family health information along with chemistry, imaging and other

3 health data points) to flag those at increased risk of cancer, diabetes and/or heart disease and suggest individualized screening, preventive therapies, genetic testing etc. Research databases could include: 1) Whole Genome Sequences 2) Clinical Trial Databases (both positive and negative) 3) Clinical Databases including Proteomics, Metabolomics, and databases pertaining to the Immune System and to the Environment. 4) Medical Imaging Databases 5) Basic Science Databases (e.g. protein structure, cell signaling) 6) Others 3. WHAT ARE THE IMPEDIMENTS? WHY ARE CURRENT EMRS INSUFFICIENT? There are several concerns: 1) Privacy and Public Trust: Could modern methods of encryption and password protection cover any such concerns? 2) Research protocols and appropriate research ethics board and patient approvals are required. 3) Interpretation of complex data: how can the patient, physician or caregiver be given the means to interpret the data? The objective is to provide clear, evidence-based, clinically relevant interpretations of data with risks, limitations and benefits. Can programming/informatics solutions resolve this? For example, you ask your GPS for the location of the closest pharmacy. You get the answer without ever seeing the incredible number of data points that your computer/gps used to make the determination. The data doesn t have to be a dedicated conclusion but give a small range of interpretations along with risk benefit values for both the diagnosis and the suggested therapy. In fact, the data can be presented in fairly simple forms to the patient and physician while all of the raw data sits behind. 4) Cost: what are the costs associated with the development of a truly integrated health informatics system (including EMRs) and how are these costs effective in providing improved health for Ontarians? This is a moving target as, for the example, the cost of individual genome sequencing moves down to a thousand dollars today and likely a hundred dollars or so within a year or two. 5) At the moment, primary care clinics are private businesses with whatever electronic record they choose to buy. There is no or limited connectivity or communication between clinics, clinic and hospitals, pharmacies etc. Compatibility is not required between the systems. Can this systematic problem be resolved?

4 4. KEY QUESTIONS Are there coordinated initiatives in Ontario that will result in effective EMRs that have the potential to talk to one another and to talk to major clinical and research databases to ensure that the promise of Personalized Medicine is realized in the future? If in fact we are not using common platforms that will allow for the required connectivity, then what are we doing to rectify the situation? Are the various jurisdictions in Ontario (hospitals, clinics, physicians, patients) on the same page when it comes to the importance of effective EMRs? Without such coordination and platforms, the people of Ontario will not benefit from the most cutting edge medicine (including prevention) and furthermore any hope that Ontario has to include the Health and Life Sciences sector as an engine of the economy will have wasted.

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