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The use of Open Source Software in medical information systems Salla Laivamaa, Arthur Le Saint & Ilya Minyaev Abstract 1. Introduction 2. Overview of medical software 3. Open Source medical information systems 3.1. First OSS in information systems 3.2. OSS information systems today 3.3. Standardization of medical information systems 4. Pros and cons of open software in medical sphere 5. Conclusions References Abstract Open Source Software has been growing on its popularity and claiming a significant part in organisations on both public and private sectors. But with only a few popular Open Source Softwares in medical sphere, we ask why Open Source is not more present in the medical software landscape? Why hasn’t Open Source become as successful in medical field, like Linux is today in computer operating system or VLC in media players per example. This paper tries to answer this question by summarizing the use of software in medical information systems nowadays and then giving more specifics of the Open Source Softwares in medical information systems. Additionally we discuss the benefits and drawbacks of using Open Source Software in medical information systems and compare them to proprietary software. Based on the results of our analysis we have estimated that the possible growth of Open Source Software in medical field could be in areas that don't involve a big risk in case of failure. 1 1. Introduction Medical field is one of the biggest research fields amongst the different universities and private companies. It has a variety of topics that go from surgery, to genomic, biochemistry but also with health-care administration system or data processing software, and many more. Open Source Software projects have been growing more and more popular over the past years, and medical oriented projects have been present since the beginning of it all. Why isn’t there more Open Source project out there then? Do the downsides of launching an Open Source medical research overcome the benefits that can come from it? McDonald et al. describes the Open Source medical landscape from then and now and propose ideas on how to support Open Source projects in medical. But the article doesn’t address the benefits and downsides of using an Open Source Software in medical field [McDonald, 2003]. In this paper we try to answer the following research question: what are the advantages and drawbacks of using Open Source Software in medical information systems. We go about answering this question by firstly giving an overview of the software in medical information systems. After this we are going back to the origins of the Open Source movement in medical sphere and then presenting the major projects in this domain today. Finally, we are going to discuss the pros and cons of using an Open Source in medical information systems today. 2. Overview of medical software The IT technologies are bound tightly with our everyday lives, and the medical field is not an exception. Different types of software are used in many sectors of medicine and neighboring areas, such as bioinformatics, genetics, etc. A large amount of software used in medicine is proprietary due to the high level of requirements to safety and sophisticated certifying process. There is a a lot of different standards in field of medical software, each verifying a specific case of a feature of it, for example IEC 62304 (Medical device software lifecycle processes), ISO 14971 (Risk management systems for medical devices), ISO 9003 (Quality management systems), IEC 60601-1 (Medical electrical equipment, part 1), AIMDD (Active implantable medical device regulation), etc. [Hobbs, 2011]. Only the products that could pass all needed standards and tests could get these certificates and be used as a part of public health care. In this particular aspect, the development process of Open Source is often hard to keep strict which will lead to complications or even inability to be approved by health associations and other jurisdictions. First medical software appeared in 1960 as an information-handling system [Radar and Electronics, 1963]. As computers and technologies become more developed, it spreads in usage ubiquitously. As well as many standards for this software were established in order to provide safety and stability, so needed in this sphere of society. One big part of medical software is hardware drivers and other low-level software, which control the behavior of medical apparatus. Due to specificity and high complexity of this type of 2 software, the used software is mainly proprietary and goes along with corresponding hardware. The same type includes implantable devices, for example pacemakers, cochlear implants, implantable drug delivery systems, different biosensors, etc. It is vital for this software to be absolutely stable and work as expected in every circumstances. Errors during executions or bugs can cause a series harm or even take lives of people. Clearly the used software has to be steady working and up to the standards. For example, in 1980s, the programming errors in X-Ray machines cause the system to give exceeded doses of radiation, and so resulting in serious injuries and lethal cases [Baase, 2003]. The question of security is also on the line of concerns, and this concern is big. Since cyberattacks are happening more frequently, who can be sure that their pacemaker is not hacked and could be manually switched off or delayed. Clearly in this case the security issue can be even life threatening. Another segment is hospital information systems, that are widely used in hospitals and other medical establishments, for storing and management of various data, for example, hospital’s stuff and patient’s records, lists of available medicines, medical tests and procedures results, finance flows, orders and etc. Essentially they provide services for institution’s personnel to access this data in order to support everyday work activities such as: accept new patients, make notes on state of patients during check-ups and procedures, write receipts, handle logistics, financial business and many others. In comparison to low-level software there are many more Open Source products in this segment, perhaps due to its more significant role in the medical activity. 3. Open Source medical information systems 3.1. First OSS in information systems Open Source Software has been present for a long time in medical information systems, and we can it trace back in history to the late 70’s with the COSTAR (COmputer-STored Ambulatory Record) information system, developed by Octo Barnett and Jerome Grossman in cooperation with Harvard Community Health Plan (HCHP) and lately released for free to public domain (the term “open source” wasn’t fully defined yet in that time of the past) [Barnett, 1979]. COSTAR is an administrative tool which was used to replace the paper patient medical record with a centralized information system. Additionally it was used to answer financial or administrative needs. In this system, the information gathered by physician was recorded to COSTAR computer system by the clerical personnel. At any time of the day doctors could access selected set of medical record information printed by the computer. The system also organized all the information into progress notes, problem lists, lists of active medications and a flowcharts of laboratory data for all patients. By the records in 1986 the system was installed in over 150 health organizations world-wide, though it was facing some problems [Kerlin, 1986]. One problem it had for example was that it was impossible to install it on IBM hardware. Kerlin writes that “COSTAR was ahead of its time and there was no educated market ready for it”. We can also name the Veterans DHCP (Veteran healthcare administration system, renamed to VistA after 1996) which released in 1978, and after important improvements in the late 90’s, it is 3 now used in every Veteran Health Administration in the U.S. ["EHR And The VA," 2013, "Veterans Health," n.d.]. This system consists nowadays of over more than 100 applications, which manage clinical, financial, administrative and other aspects of health care institutions [Brown, 2003]. VistA applications work with common data protocol, and utilize the same core building blocks to provide different functionality, such as security control, device access and communication. The system could be deployed on many different platforms, which basically makes it possible to use it almost anywhere. VistA implementations also spread beyond U.S. and have been deployed in hospitals in Mexico, Finland, Germany, Egypt, etc. [Conn, 2007., Maduro, 2006] Theses two pioneering systems were successfully deployed at a time where the infrastructures were not what they are in the current time. They opened the path for every other Open Source Software in the medical information systems. Which we are going to go over a few more big medical information system projects later on this article. 3.2. OSS information systems today One of the first focus point in Open Source medical informatics is EHR systems (Electronic Health Record). As said in this article of the Journal of Clinical Oncology [Miriovsky, 2012], the more digital our medical records are becoming, the more data is going to be stored in databases. Real time analysis of this big data can provide point-of-care evidence to the medical staff, tailored to patient-level characteristics. The mains challenges for the developers and the medical community are facing today is to standardize and ease the access to said databases but also it is to improve the used algorithms of the real-time analytics software. One of the most popular Open Source electronic health records systems and medical practice management solution is OpenEMR [OpenEMR, n.d.]. Which is running on every Operating Systems, and additionally it allows everything that a medical practice may need to function properly. This includes for example a financial manager, patient scheduling, an EMR, prescriptions care and a lot more. A lot of configurable forms for all medical specialties and multi language support are also available. A fairly strong business community of companies are offering their services and support. This successful project shows that Open Source is a very good and viable option for EMR. Still keeping its growth strong, OpenEMR went from 4000 monthly downloads in december 2014 to more than 6000 today. [Groen, 2013., "Open Source Health," 2014., "OpenEMR Medical," n.d.] Other similar product is OpenMRS, which is a nonprofit project found by Regenstrief Institute (Indianapolis, IN) and Partners in Health (Boston, MA) in 2004. It is targeted for developing countries, and number of implementations have been deployed across Africa [Yellowlees, 2008]. OpenMRS is a software platform and a sample application which enables design of a customized medical records system with no programming knowledge needed (although medical and systems analysis knowledge is required). The core of the system is a conceptual database structure which is not dependent on the actual types of medical information required to be collected or on particular data collection forms and thus can be customized for different use cases. 4 We can also name another Open Source initiative, which is called openEHR Foundation. This organization's aim is to create an interoperable, standardized Open Source EHR system and to improve healthcare all over the world [Yellowlees, 2008]. Basically, openEHR provides an open standard for information as well as various templates for different use-cases, on whose a highly customisable system could be developed. Based on the information from their website, applications based on openEHR platform are deployed all over the world, in Australia, Brazil, the Netherlands, Norway, Portugal, Russia, Slovenia, Sweden and UK. 3.3. Standardization of medical information systems The problem is that without standardization, Open Source information systems in medical will reach a ceiling and will not be able to be used/developed internationally, considering every country specificities. This will have to go through first with the development of toolkits, frameworks and generally a more common ground to communicate and process information. Founded in 1987 the Health Level Seven International (HL7) is a non-profit, ANSI-accredited standards developing organization, which dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that can support clinical practice and the management, delivery and evaluation on variation of health services [Dolin, 2016]. The Health Level Seven International (HL7) created a Reference Information Model (RIM), which is a static model of health-care information that can broadly and abstractly cover all aspects of a health-care organization’s clinical and administrative information [Eggebraaten, 2007]. The whole family of Health Level Seven International (HL7) consists of many standards for specific uses, for example Messaging Standard - an interoperability specification for health and medical transactions, Clinical Document Architecture (CDA) - an exchange model for clinical documents, Arden Syntax - a grammar for representing medical conditions and recommendations, GELLO - a standard expression language used for clinical decision support, and many more others. The HL7 continuously keeps developing standards (the last version is number 3) and offers certification testing in order to help achieve industry-recognized levels of proficiency and expertise. Open standards also provide opportunities to build consumer-aimed client applications. One example of it could be a mHealth, architecture that facilitates data exchange between the doctors and patients. It mainly aimed for treatment of chronic diseases, which often happens outside of traditional clinical settings. For sufficient treatment in this case clinicians depend heavily on patient reports of symptoms, side effects, and functional statuses. Clients use mHealth to collect and share their data with therapist, who in his turn look for patterns of response and guide the patient to titrate his medications. In addition, hospitals and other health establishments could use this rich data to conduct deep analysis or to create custom applications, one for example could be on what symptoms to monitor, when, where, and how, or what data sources to incorporate. [Estrin, 2010] Through all these different examples, we can see that Open Source projects in medical can be successful, recognised and used at an international stage. But this success can only happen if we have a rich group of enthusiasts and obviously open standards. 5 4. Pros and cons of open software in medical sphere IT has many challenges in the health care department. Patient care is often provided by competing facilities which most of them don’t share their information. Separate providers, including clinical laboratories, hospitals, physicians and rehabilitation centers, all need to be included into a network that can be easily used to share all of their patient information. Sharing patient information amongst all health care providers is particularly important so that the patient can get the best possible health care with the most cost-efficient way. [Goulde, 2006] It would be important that the software development would focus its’ resources more on developing a smaller number of equivalent software solution in order to solve IT problems in health care. By focusing its’ resources for example on electronical medical records (EMRs), it can become more cost-efficient, standardized and easier to modify and implement. Open Source software seems to be a promising solution to the IT problems in health care. [Goulde, 2006] Open Source Software facilitates open standards, which are generally beneficial for all sides in health care. First of all, not worth mentioning that institutions that have the same standard could be easily integrated into one system. Medical establishments could extend used open standard for their needs and still be compatible with other facilities using the same standard. Developers, in cooperation with establishments, could write client applications through which public health customers can access their data. In medical science it is essential for the terminology to be standardized. It is hard to measure the true value of health care services when the integration costs and interoperability in proprietary software are so high. The reason why proprietary software vendors are not in the custom of standardizing their software is because it makes it easier to transfer information to a different system. This is not a desirable to proprietary vendors since customers are costly to them. This cost comes from firstly having to have to modify a software according to a specific customer standards and additionally to keep up with the updates without asking for too much money, otherwise the customer might want to change it’s vendor. Because many proprietary vendors don’t have a standardized software many health care professionals insist on using Open Source Software in order to have comparable treatment data. [Gropper, 2011] In order to have an effective medical practice additionally it is crucial to have ongoing support for the used software. Another benefit that comes from using Open Source Software is the support system and maintenance. Additionally the user can choose whoever they want as their service provider. Often times when using proprietary software the user is dependent on the one specific vendor for support and most often their priority is in getting new customers for their system. [Gropper, 2011] The biggest benefit from Open Source Software to the healthcare industry is that the software is vendor-neutral. This means that any health care facility that uses that specific Open Source Software does not depend on any one provider [Goulde, 2006]. A lot of times changing a proprietary software or moving away from it can be difficult and expensive. This is specifically designed to be this way so that the vendors can charge more from new upgrades and the 6 support they offer [Gropper, 2011]. The establishment using Open Source solution can, of course with help of own programmers or hired ones, modify it in order to meet their own needs better or to achieve additional functionality. If the license allows, these upgrades would be open to world and some other institution could utilize them without spending precious work time for doing double-job. This is why the vendor-neutrality is one the most relevant advantage when considering using Open Source Software in the healthcare industry but there are also other perks including it being inexpensive, flexible and the opportunities to be innovative. The vendor-neutrality can also make it easier to find a funding in a public sector thus bringing better quality and more inexpensive health care. [Goulde, 2006] For the direct customer in hand the most appealing perk of Open Source Software in the healthcare industry is that the software is easy to obtain. The software can be easily found and downloaded and the only obligation that the the hospitals, physicians, laboratories or who ever is the user is that they need to respect the licensing terms. There are no licensing fees to pay and the software can be supported internally, though developers could ask for donations to support their work or provide additional services for a certain fee, such as technical support, which could be useful for enterprise institutions. It is a huge advantage that the only cost that the health care facilities are paying are for the resources that are needed in the installing and supporting processes [Goulde, 2006]. And these cost is anyway much lower than one would be needed for acquiring, configuring and maintaining the commercial solution. For example the cost for setting the multiple hospital VistA network in one state in U.S. was implemented for the one tenth of the price of setting the equivalent commercial product in another hospital network in the same state [Gold, 2015]. An aspect that could be even more important than the low-cost is the medical knowledge that gets distributed all over the global world. Open Source projects like OpenMRS are used as a tool to find cures for example HIV, malaria and tuberculosis. [Gropper, 2011] Another benefit of using Open Source Software in healthcare are the ethical advantages that come with it. In healthcare industries it is very important to have shared information to be available instantly and accurately. For medical fields software should be kept open so that it’s clear what formulas are behind different functions since this information could have an affect on a patient care. [Gropper, 2011] Open Source Software is a safer solution for patient safety. Proprietary software suffers from its secret ways of working unlike Open Source Software which utilizes code that has already been written by someone else. When proprietary vendor comes out with new medical software it is more likely to include bugs that have been solved by other vendors. Where as Open Source is replicating medical software that has already been proven to be working and where the patient safety hasn’t suffered. [Gropper, 2011] While there are many benefits that come from using Open Source Software in a medical field it comes with its downsides as well. One concern that might be considered as the biggest is the security issue. Since in Open Source Software the code is publicly available it can be much easier for hackers to get access to it. Of course for a skillful hacker, that can pass the security issues in a hospital system, this is possible to do whether the software is Open Source or proprietary. For Open Source Software the action just can be done faster [Settles, 2014]. Although this statement is still debatable, because on the other side the open nature of software 7 involves more broad assessment of the security of a system, makes bug fixing easier and more likely, and encourages developers to spend more effort on the quality of their code. [Reynolds, 2011] While the support was mentioned in the advantages of Open Source Software it can be a disadvantage as well. It is not that common that Open Source Software would give out such detailed phone-based technical support around the clock as a proprietary provider could give [Settles, 2014]. In the case when used Open Source Software is adopted, its creators might provide some paid option, for example “Enterprise edition”, which could include so useful for big establishments support and other additional features. And for sure, such move would be much cheaper than licensing a proprietary software. Another problem of applying Open Source Software to medical systems was already briefly mentioned in the beginning. The existing standards require serious approach to development of medical software in order to provide a determined level of functional safety. Certain process techniques, system design, advanced testing, these and more other aspects need to correspond standard’s demands, otherwise a piece of software won’t get certificate and won’t be allowed to use in public health establishments. For example, harmonized in EU and USA standard IEC 62304, which ensures that certain medical software is developed with quality management system, though it doesn’t give specifications of which software development model must be used or which documentation it must have [Hobbs, 2011]. Instead it claims a number of procedures and activities that are required through the development, which will ensure that output software can provide a certain level of safety. Just taking into account only this one standard, it is obvious that taking an already existing for a long time Open Source Software into use in a medical field could become problematic. So if some organization aims to develop an Open Source product for medical usage, it should consider beforehand the possible certifying issues and ways to encounter them easily. 5. Conclusions We have searched for examples of existing Open Source Software in medical field and described their status. In addition we made a analysis of benefits and downsides of Open Source Software, their meaning and effect in the context of medical sphere. Despite of all advantages of Open Source Software, it is still not widespread in medical field. The main area where it could get popularity is the one which doesn’t involve great risks in cases of failure, for instance medical information systems or software for not-critical hardware. The most useful consequences of using an Open Source is low costs in setting, vendor-neutrality and increased code review, which generally leads quicker bugs detection as well as fixing. The barrier to entry for Open Source Software in healthcare is a need of passing certifications, a problematic strict process for “freely” developed software. Due lack of knowledge and a vast area of research, the study doesn’t call for rich analysis of Open Source phenomena in medical field. For future research it is advised to gather more data about Open Source implementations there in other medical fields (for instance, implantable 8 devices) or investigate standards for medical software and write guidelines for designing such systems. References Baase, S. (2003). A gift of fire. Social, Legal, and Ethical Issues in Computing”. Prenctice-Hall. Barnett, G. O., Justice, N. S., Somand, M. E., Adams, J. B., Waxman, B. D., Beaman, P. D., ... & Greenlie, J. K. (1979). 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