Jesse Asafo-Agyei Boamah Linacre College Supervised by: Prof Alison Noble

Transcription

1 A Market Research Project conducted in collaboration with Coller IP Management Ltd Jesse Asafo-Agyei Boamah Linacre College Supervised by: Prof Alison Noble Trinity Term 2012

2 2 This report has been produced by Mr Jesse Boamah whilst studying at Coller IP, as a formal contribution towards his PhD studies in from the Centre for Doctoral Training in Healthcare Innovation at the University of Oxford. The report is made available for use but the contents of this document may not be reproduced in whole or part, nor passed to any organisation or person without the specific written permission of Coller IP Management Ltd. Please note that the views expressed here on companies and individual project cases draw on information available in the public domain. We have not sought to establish the reliability of these sources. Accordingly no representation or warranty of any kind (whether express or implied) is given by Coller IP to any person as to the accuracy or completeness of the report. Moreover the report is not intended to form the basis of any investment decisions and does not absolve any third party from conducting its own due diligence in order to verify its contents. Coller IP Management accepts no liability of any kind and disclaims all responsibility for the consequences of any person acting or refraining to act in reliance on the report or for any decisions made or not made which are based upon this report.

3 3 Executive Summary This report provides a technical analysis of the patent landscape and current development of Health Information Technology (HIT) and health diagnostics across Europe, UK, and USA. It considers the commercial and legal strengths of the patent portfolios of leading organisations within the field. The analysis of the landscape is achieved by mapping the overall field of Healthcare IT within target markets using proprietary analytical and secondary research tools. In today s competitive environment, knowing and understanding the marketplace is proving to be very essential. To succeed in emerging markets, healthcare firms are required to evolve quickly in a fast-paced demanding healthcare environment. The drive for investment in Health IT is, particularly, a suitable solution due to the promise of quality and efficiency gains. Technological advances and national initiatives (e.g. the NHS National Programme for IT) to reduce costs have also spurred advances in healthcare informatics by adopting an ongoing support for information systems. These efforts aim to standardize nomenclature, formats and communication protocols; thus enhancing interoperability and overcoming problems of fragmentation. Wide applications of health information systems to improve patient care include Electronic Health Records and Computerised Provider Order Entry. Also imaging applications such as Picture Archiving and Communications Systems have helped in improving workflow in hospitals. As technical developments are made, there are parallel increases in the number of patents being filed to protect the underlying inventions. Information based on patent landscaping can provide a useful insight to support decision-making. As well as providing market intelligence for healthcare firms, it helps in understanding and considering the hotspots of developments, improving formulation of patenting strategy, and identifying key suppliers and partnerships for further technological development. Key Findings: Significant advances are being made in increasing efficiency through novel information technologies, component design enhancements and other advances in integrating communication systems. Increased patenting activity and patent rights in Health IT can be attributed to a move towards remote care to reduce stays in hospitals, and encourage self-monitoring. The subsets of patenting in Health IT are relatively small, compared to other industries, and suggest that significant opportunity for further development and growth remains. There is a predominance of patenting activities in the United States of America. Active patenting has been carried out mainly by big firms such as Philips (The Netherlands), Siemens (Germany), GE Healthcare (USA), and Medtronic (USA). High patenting activity is seen in patient diagnostics and monitoring. Abbott Diabetes Care has significant concentrations of patents in glucose and insulin monitoring devices. Patenting activity in Health IT includes developments in miniature functional recording, light emitting technologies and image diagnostics that are on the increase.

4 4 Table of Contents EXECUTIVE SUMMARY...3 TABLE OF CONTENTS...4 LIST OF FIGURES...5 LIST OF TABLES INTRODUCTION SCOPE HEALTHCARE ICT MARKET OVERVIEW THE NEED FOR INTEGRATED ICT SOLUTIONS HEALTHCARE ICT MARKET STRUCTURE HEALTHCARE ICT TRENDS HEALTHCARE ICT MARKET DYNAMICS DRIVERS & OPPORTUNITIES EU ehealth Policy NHS National Programme for IT (NPfIT) The US HITECH Program RESTRAINTS PATENT LANDSCAPING SEARCH STRATEGY KEY SEARCH RESULTS & ANALYSIS Landscape Map Results DISCUSSION CONCLUSION REFERENCES APPENDICES APPENDIX A General Applications OF Health IT Computer-based Medical Records Management, Epidemiological Surveillance, and GIS ehealth, Telemedicine, & Telehealth Knowledge-based Systems Wearable Intelligent Technology Systems (WITS) IMAGING SYSTEMS Picture Archiving Communication Systems (PACS) Radiology Information System (RIS) APPENDIX B Tables...25

5 5 List of Figures Figure 1 Scope of Healthcare IT that extends beyond the clinical domain to include information systems within administrative and commercial domains (Adapted from Berg, 1999)...6 Figure 2: Top 20 Assignees in Remote Health IT Monitoring. The graph shows that Philips is in a dominant position with over 70 patents...13 Figure 3: Top Five Assignees by year. Active patent filing has been carried out by Medtronic, Philips, and Cardiac Pacemakers Inc...13 Figure 4: Total patent rate of filing trends relating to Remote Monitoring Health IT Monitoring. Patenting in this area has risen in the last 20 years; gradual increase from The highest number of patents published is seen in 2011 (over 420 patent documents)...14 Figure 5: Top Assignees per region. Of the regions studied, most of the patenting activity is seen to occur in the US, then Europe, with Philips the major player. From the graph, GEN Electric is the sole patentee of Remote Health IT Monitoring in the UK. Analysis was performed by pooling international patent filing and issuance data from both DWPI and the International Patent Documentation Centre (INPADOC) family Figure 6 Overview: Patent landscape for 2804 INPADOC families on Remote Monitoring Health IT Monitoring. Common topics/keywords are closely clustered around a central coordinate whereas unrelated ones are more spread out. Most activity is seen in diagnostic monitoring...15 Figure 7: Themescape map showing a focused region of Diagnostic Monitoring. The dots are specific patents. The blue ocean represents low patenting activity in those regions. The heights of ridges and peaks indicate a concentrated patenting activity...16 Figure 8 Philips PACS worldwide installed base. Over 1800 PACS systems for Radiology and/or Cardiology installed worldwide. Dots give indication of installation of one ore more radio and/or cardio PACS system (Adapted from Muduroglu, 2007)...24 List of Tables Table 1 Recent Rate of filing per Top 5 Assignees in Regions (US, EP, and WO)...25 Table 2 Document Count per Publication Year...27 Table 3 Selected and recent patents documentations relating to miniature functional recording...28 Table 4 Selected and recent patent documentations relating to Patient Parameters...29 Table 5 Selected and recent patent documentation relating to Diagnostic monitoring...30

6 6 1. Introduction Health Information Technology (HIT) can be defined to encompass the growing disciplines of network systems, information computer technology, and communication systems that provide support across healthcare. It covers the clinical, technical, public and commercial/administrative domains of diagnostic healthcare (Fig 1) 1. HIT further enables information exchange between providers, consumers, government, and insurers. The potential to improve the safety, quality, and efficiency of healthcare characterises the need for innovative healthcare informatics 2. This potential to improve care makes broader diffusion of IT desirable. Healthcare institutions are increasingly reliant on information about patient care, results, and a capability to coordinate and integrate services. In delivering excellent healthcare to the population, much depends on how electronically captured information is retrieved, managed and used by the healthcare professional. Information and Communication Technologies have advanced in parallel with the information needs of modern healthcare and proved a useful tool across national healthcare systems. There is a growing interest from top management and healthcare professionals in recognising its benefits and, thus, continue to allocate funds for its development and further institutionalisation. For example, Electronic Health Records (EHR) and Computerised Provider Order Entry (CPOE) are acknowledged as being critical to transforming the health care industry 3. Advances in high speed computing performance, image processing, and database technology have ensued at a rapid rate. Medical Practice Medical Informatics Information Systems Healthcare IT Healthcare Management Figure 1 Scope of Healthcare IT that extends beyond the clinical domain to include information systems within administrative and commercial domains (Adapted from Berg, 1999) 1 Berg, J., Healthcare Informatics into the 21 st Century, Business Insights Ltd Chaudhry, et al., Systematic Review: Impact of Health Information Technology on Quality, Efficiency and Costs of Medical Care Annals of Internal Medicine. 2006; 144:E-12-E Ash, J.S., Gorman, P.N., Seshadri, V, Hersh, W.R. Computerised physician order entry in U.S. hospitals: results of a 2002 survey. J Am Med Inform Assoc. 2004;11:95-9.

7 7 The growth of health information management systems is based on a number of assumptions 4 : Information is a major resource which is crucial to the health of the population Health information systems should be viewed on a continuum, from patient data (clinical), to accumulated data (performance, utilization), to knowledge-based data (decision support), to comparative, community data (policy development) The quality of data and its transformation into information are basic to the efficiency and effectiveness of all communication and information systems. Continued development and deployment of health informatics technologies could be beneficial. A reflection of this transformation is seen in the increase in patent volume activity in the healthcare/medical industry (See section 5, Figures 8, 9). Patents are at the forefront of advancing technologies and represent the best facilitator of the knowledge flow of IP. Demand for patent publication is increasing. Patents are dynamic, reliable, and doublesided; being characterised by two words: disclosure and exclusivity. These are seemingly implemented by the grant of patent rights to assignee/inventor of the patented technology for a time period of generally 20 years from the date of filing. The exclusivity period rewards by providing a time window for firms, who have made patent applications, to recover investment either through licensing or commercialisation of the novel technology. Market potential largely drives the rate of filing of patents in various jurisdictions. A patent landscape report of the aforementioned field of interest generates intelligence and highlights essential technologies, major patent holders, scientific and technical information, and knowhow; that enable strategic decisions to be made in order to formulate appropriate judgements towards technology and product implementation, identify regions of the market to avoid (due to intense patent activity); highlight areas to seek licenses and collaborations; and observe regions of open space (that may arise due to imminent patent expiry or lack of inventions in the area) Scope The objective is to assess the patenting activity centring around the development in Health Information Technologies. In doing so, it shows ways that patent and non-patent assets can be combined to build a picture of the technology market and an overview of the innovation landscape in the field of healthcare IT. The report segments include areas: To define and analyse the healthcare IT market To analyse key trends in innovation and developments of information technology To assess the healthcare IT market, with respect to current applications, and services that are currently deployed To analyse patent landscape coverage, including the principal assignees across regions 4 Al-Shorbaji, N., Health and medical informatics. Cairo: World Health Organisation Available from: Accessed May 2012

8 8 The intended audience of this report includes Healthcare providers, Healthcare Institutes, Healthcare Instrument manufacturers, Healthcare consultants, and Inventors in the field of IT. 2. Healthcare ICT Market Overview The emergence of innovative information systems is changing the future of healthcare delivery. A common theme of these emerging technologies is electronic devices, such as smart phones and wireless communication systems that are systematically being used to alter clinical care outcomes. For example mhealth is being used to access and acquire patient data in real time to enable the health worker to monitor patient care. The global market size for healthcare informatics hardware, software and services is predicted to grow from $99.6 billion in 2010 to $162.2 billion in 2015, at a CAGR of 10.2%; making it one of the fastest growing markets of the healthcare industry The Need for Integrated ICT Solutions The progress in processing information is changing in the health industry. The healthcare provider IT market is on the rise globally. It is fuelled by the need to reduce healthcare costs; increasing demand for rapid and efficient delivery of healthcare; improve quality of care; improve medication safety; and enhancement of workflow (clinical/administrative) in hospitals. Peter Byass comments that a better collection of data will lead to better health outcomes and policies 6. In the healthcare setting, clinicians face an increasing gamut of diagnostic and therapeutic options and copious amounts of patient data. In improving flow and data quality, the use of ICT will further allow for better depiction of disease burdens and treatment 7. A well-known quote from U.S. health policy expert, Information is care, 8 implies with a strong health information system, health workers are able to respond quickly with suitable measures. As well as improving individual patient care, an interoperable HIT system will serve to bring many public health benefits including: An early detection of infectious disease outbreaks in regions/nations Improved tracking of chronic disease management; and Evaluation of health care based on value and quality that can be compared 5 Markets and Markets, 2011, World Healthcare IT Market: Trends & Forecast ( ), Available from: Accessed May Byass, P., The Unequal World of Health Data. PLoS Med 2009: 6(11) 7 Kerr, K., Norris, T., Improving Health Care Data Quality: A Practitioner's Perspective." International Journal of Information Quality. 2008;2(1): Berwick, D., Escape Fire: Lessons for the Future of Health Care. Jossey Bass

9 Healthcare ICT Market Structure A good understanding of the healthcare industry and health information infrastructure can assist in the awareness of the shifting requirements of its affiliated IT market. There are three major contributors within the healthcare industry the providers, payers, and consumers. Providers of healthcare include hospitals, nursing homes, private physicians and educational institutions. Payers within the industry include governmental and nongovernmental organisations. Consumers include patients keeping up-to-date with their medical data. The healthcare provider market is segmented to large hospitals, medium-sized hospitals, small hospitals, and physician practices. The large and medium-sized hospitals tend to behave like standard, enterprise customers in the macro IT space 9. Small hospitals are more adverse to capital expenditures. As the industry shifts towards a more integrated system, an insight into the needs of the contributors could lead to the design and development of systems that will simultaneously cater to unmet requirements. Healthcare IT infrastructure and funding varies in countries. The initiative of the National Programme for IT (NPfIT) has meant that the UK spends the most on Health IT than any other country in Europe, with 2.4bn of the EU s total of 8bn; France and Germany tag along next at about 1.2bn each 10. A large proportion of the market is accounted for by GE Healthcare (USA), Siemens Healthcare (Germany), Philips (The Netherlands), and Medtronic (USA). The main healthcare information technology (HIT) vendors for large hospital markets are predominantly GE Healthcare and Epic Systems 11. Medium-sized and small hospital markets tend to be dominated by McKesson Healthcare ICT Trends The increase in demand of healthcare has meant that errors in diagnosis have also increased. Such errors have also led to claim settlements. This has led to the investment of specific areas of technology that look to improve management of patient health information and remote patient monitoring. These include: Electronic Health Records (EHRs), Picture and Archiving Systems (PACS), Radiology Information System, Point of Care Information Systems, Wearable/ Implantable Health IT Systems, E-Prescribing, Health Information Exchange (HIE) Networks, Personal Health Records (PHRs), and Mobile Health. Healthcare IT is showing growth. According to Dow Jones Venture Source, in 2011, venture capitalists made investments of $659 million in 91 deals; an increase of 25.5% from $525 9 Harding, B.D., Healthcare Information Technology, Present Investment and Future Outlook in the American Healthcare Market, Institute for Health Technology Transformation Available from Accessed May National Programme for IT in the NHS; Accessed May Investing in Healthcare IT. The Wall Street Transcript. 10 Aug 2009 Accessed May Harding, B.D., 2010

10 10 million in 71 deals in During the first quarter of 2012, an amount of $102 million was raised by health IT companies; a 75% increase over the same period in From 2010 to 2015 and at a CAGR of 16.7%, EHRs are expected to be the one of the highest growing market in healthcare IT. Another area of increasing growth is that of CPOE, where growth in the same period is expected to be 16.5%. On combination, point of care information systems (e.g. cardiovascular and oncology information systems) and intensive care systems are expected to have a CAGR of 15.1% from 2010 to The fastest growing market for Hospital Information Systems, from 2009 to 2015, is expected to be that of the US (Markets and Markets, 2011) The rise of mobile communications holds tremendous potential to ease the flow of health information through SMS messaging, voice calls, and wireless data 15. In 2011, the International Communications Union (ITU) estimated that over 5.3 billion mobile subscriptions were made worldwide, with a more concentrated subscription (3.5 billion) found in low and middle income nations 16. The potential growth in, EHRs, E-Prescribing, Value-Based Health Plans, and Services, is discussed in greater detail in Appendix A. 3. Healthcare ICT Market Dynamics 3.1. Drivers & Opportunities Currently, European governments and healthcare providers are heavily investing and implementing EHRs to harmonise health systems across regions. This implementation is closely linked to health cards, where such cards are also linked to an interoperable network storing patient data EU ehealth Policy A number of European countries are pursuing strategic implementation of investing in Health IT infrastructure whilst seeking assurances that implementation will be a success. The ehealth Action Plan, by the European Commission, serves as a guide in pursing healthcare informatics. 17 The definition of ehealth in the plan includes health information networks, electronic health records, telemedicine services and communication services. The policies and initiative set out in the ehealth Action Plan are: 13 Moukheiber, Z., Forbes Midas List: The VCs Who Are Investing In Health IT Available from: Accessed May Markets and Markets, Ranck, J., Health Information and Health Care: The Role of Technology in Unlocking Data and Wellness A Discussion Paper, (Washington, D.C.: United Nations Foundation), February Available from: Accessed May Ranck, J., e-health making healthcare better for European citizens: An action plan for a European e-health area, Commission of the European Communities, 30 th April 2004, Accessed May 2012

11 11 A national plan for each member state to be developed Identification of a common approach to patient identifiers Identification of standards for message and data interchange Support for greater cost information for patients, insurance schemes and providers Provision of an EU health portal and support for warning and surveillance services Creation of an EU wide ehealth forum Support for benchmarking and dissemination of best practice The demand for EU health care provision is driven by an increasing age demographic and a large number of baby boomer retirees NHS National Programme for IT (NPfIT) The United Kingdom established the NPfIT program (projected at 12.4bn) following the recognition that IT was pivotal in delivering better patient care. The program sought to create an integrated care record service, an electronic appointment system and build an infrastructure and network accessible to health care providers by The US HITECH Program In recognising the role that IT plays and to spur its growth, legislators in the US apportioned $20 billion of the total $787 billion for the American Recovery and Reinvestment Act (ARRA, 2009) for health IT via the health information technology for economic and clinical health (HITECH) Act The HITECH Act was to accelerate the development and diffusion of health IT for a secure, interoperable, and patient focused transformation of the nation s health system through a number of grant programs, policy activities, and strategic partnerships. Further insights into the HITECH program are documented on the web page of the US Department of Health and Human Services Restraints A universal adoption of Health IT presents its challenges. Currently, the backbone of the HIT initiative is the well-known and ubiquitous EHRs. There are layers of complexities in the adoption of EHR. Only 20% of physicians and 10% of hospitals are currently using basic EHRs Most notably, from a growth perspective, the EHR itself is still a work in progress. The ARRA funds are expected to help boost adoption to 55% and 85% by 2014 (Harding 2010). 18 Flanders, E., The real meaning behind meaningful use. Radiographics. 2010;30: US Dept of HHS. Available from: Accessed May US Dept of HHS. Available from: Accessed May Flanders, Blumenthal, D. DesRoches, C.M., eds. Health Information Technology in the United States, 2008: Where We Stand. Robert Wood Johnson Foundation Available from: Accessed on 10 May 2012

12 12 4. Patent Landscaping 4.1. Search Strategy The patent database analysis within this report is driven by the Thomson Innovation bespoke software package. The patents analysed were European Patents Granted, European Applications, United States Patents Granted, United States Patents Applications, United Kingdom Granted Patents, United Kingdom Patents Applications, WIPO PCT Publications, Derwent World Patents Index, Various secondary search tools such as scientific and technical papers, were also used; all searches being based on a 20-year range, i.e. applications filed from The IP landscape for HIT highlighted in the following sections was generated using the following search strategy. Initially, a wide search with a high level IPC code with key terms (such as remote OR health,) and derivate spellings gave a patent search results of over patent documents. The searches also used International Patent Classifications United States Patent Classifications, and Derwent Classifications. A more refined sub-search using the IPC code A61B* and the list of keywords (remote AND health* monitor* AND database) through the patent (titles, abstracts, claims) eliminated those that were not directly relevant. The resulting patents were then collated by assignees and where an assignee was not given (as it s the case for US patents before 18 months) they were collated on the basis of the inventor name. Pseudo maps with contoured hills that identify and represent corporate patent themes/activity were generated using Themescape IP analysis platform from the Thomson Innovation software Key Search Results & Analysis Based on the search strategy outlined, 2804 patent families relevant to HIT were identified. Of these families 920 were related to diagnostic monitoring, 240 to patient parameters, 118 to cardiac implantables, 81 to image diagnostics, 49 to light emitting, and 46 to miniature functional recording. Data analysis was based on these 2804 patent families. The study of the patent literature highlights many active players covering a wide range of healthcare information technology. The active players in the landscape generated using the above search strategy include Philips, Medtronic, Cardiac Pacemakers, GEN Electric, Abbott Diabetes Care, and Siemens. As seen in Figure 4, Philips heads up the top assignees in remote Health IT monitoring. Medtronic and Philips have been very active in patenting their technologies each year (Fig 5). Medtronic was seemingly dominant between 2004 and Its dominance however is overcome by Philips who tripled its filing rates from five in 2005 to over 15 patent documents in Also noteworthy was the emergence of Abbott Diabetes Care that gradually increased its patenting activity from three in 2008 to over 15 in The Boolean connector E.g. Using remote or health searched for documents that contained either term or both terms Boolean connector that represents many variable characters e.g. monitor* represents monitors and monitoring Boolean connector E.g. Using health AND monitor will search for documents that contained both terms

13 13 rate of filing has seemingly increased each year (See Appendix B, Tables 1 and 2). Regionally, of the countries assessed, most patent activity occurs in the United States of America; the top 5 assignees are seen in figure 7. Europe has also been a popular region, where firms, Philips and Cardiac Pacemakers were slowly increasing their patent filings. Figure 2: Top 20 Assignees in Remote Health IT Monitoring. The graph shows that Philips is in a dominant position with over 70 patents. Rate of filing Figure 3: Top Five Assignees by year. Active patent filing has been carried out by Medtronic, Philips, and Cardiac Pacemakers Inc

14 14 Patent Publishing Trend Figure 4: Total patent rate of filing trends relating to Remote Monitoring Health IT Monitoring. Patenting in this area has risen in the last 20 years; gradual increase from The highest number of patents published is seen in 2011 (over 420 patent documents) Rate of filing Number of Patents Figure 5: Top Assignees per region. Of the regions studied, most of the patenting activity is seen to occur in the US, then Europe, with Philips the major player. From the graph, GEN Electric is the sole patentee of Remote Health IT Monitoring in the UK. Analysis was performed by pooling international patent filing and issuance data from both DWPI and the International Patent Documentation Centre (INPADOC) family.

15 Landscape Map Results Trends and relationships were visualised on maps. Each dot on the landscape map represents an individual patent. Different owners of different patents are shown in different colours to distinguish them. This helps to identify particular sub-areas where various competitors are concentrating their patents and R&D. The landscape map in Fig 8 shows a cluster of dots (that represent patent documents by different companies) in regions such as diagnostic monitoring and light emitting. Generally, patent documents that lie closer to one another are considered as being technically related and the snow covered peaks identify areas of high patenting activity. Also represented, are the activities of major patent holders. An evident observation of the patent families is the significant overlap within the search content; as indicated by the occurrence of red, green and yellow dots in Figures 8 and 9. This suggests areas of congested patent rights. Figure 8 shows the map of patents in remote Health IT monitoring. The technologies are clustered together according to different key technologies such as Cardiac Implantable, Diagnostic Monitoring, Light emitting, etc. The themes are grouped according to the assignees (Fig 6). Figure 6 shows how patented technologies from each firm are spread with respect to the competitors. Companies, such as Medtronic and Philips, hold patent rights spread across many technical regions, whereas firms such as Abbott Diabetes Care have a particular niche in diabetes management/monitoring system. Some regions indicate gradual developments. These are miniature functional recording, light emitting sources, and image diagnostics. These are discussed in the next page. Miniature Functional Recording (46 Docs) Medtronic (87) Philips (83) Cardiac Pacemakers (64) Siemens (49) GEN Electric (45) Abbott Diabetes (43) Light emitting Cardiac Implantable (118 Docs) Diagnostic Monitoring (920 Docs) Image Diagnostics (81 Docs) (49 Docs) Patient Parameters Database (240) Figure 6 Overview: Patent landscape for 2804 INPADOC families on Remote Monitoring Health IT Monitoring. Common topics/keywords are closely clustered around a central coordinate whereas unrelated ones are more spread out. Most activity is seen in diagnostic monitoring.

16 16 Miniature Functional Recording: Further analysis of the region shows no major player within. The region mainly consists of individuals/inventors. Of the big companies, only Medtronic and Siemens hold the majority of patent documents (2 documents only). Philips and IBM each hold one patent within that region. Most of the patent activity occurs in Only 3 documents have been patented in The novel technologies relate to sensors that measure, analyse and record patient functionality as well as forming a database that communicates to other systems on a server. A few recent patents are list in Appendix B. Cardiac Implantable: The major patent players are Medtronic (48 holdings), Cardiac Pacemakers (38 patent holdings), Pacesetter Inc (8 holdings) and Biotronik (4 holdings). There are holdings from companies such as Philips, Siemens, and IBM who each hold a patent. The patented technologies consist of novel designs that are implantable, have a programmable sensing mechanism to measure heart rate and also to deliver drugs. Diagnostic Monitoring: This region shows the most patenting activity. Focusing in this region alone, four snow-capped peaks can be seen (Fig 7). These areas include novel technologies that relate to physiological rate temperature systems, person/patient mobile telephone, module memory rate systems, and temperature predetermined transmitter systems. There are 37 patented documents in physiological rate temperature systems, peak 1. The novelties of these documents are that they have remote sensors that detect, monitor, record, transmit, and stream patient data, such as blood pressure and temperature. 5 Medtronic (23) Siemens (16) Philips (36) GEN Electric (15) Health Hero Network (5) Abbott Diabetes (41) IBM (8) Figure 7: Themescape map showing a focused region of Diagnostic Monitoring. The dots are specific patents. The blue ocean represents low patenting activity in those regions. The heights of ridges and peaks indicate a concentrated patenting activity.

17 17 From Figure 7, the peaks are labelled with two separate words that are individually representative of the content of the documents in that peak. E.g. Peak 1: Physiological Rate Temperature; Peak 2: Person Mobile Telephone; Peak 3: Module Memory Rate; Peak 4: Temperature Predetermined Event The person mobile telephone, of peak 2, is made up of 45 patent documents. The novelties of these technologies are that they are mobile system capable of monitoring, tracking, receiving and transmitting user pulse rates and other functional parameters via a server. The module memory rate systems, peak 3, consist of 90 patent documents. The innovations relate to programmable codes that store patient physiological data either through a wireless or server system. Some of the innovations are implantable and also have a GPS module system for tracking purposes. A cluster of pink dots relating to glucose level insulin can be seen in peak 5 of figure 9. This is a unique niche for Abbott Diabetes Care only. Their patented technologies are sensors that are capable of measuring and monitoring continuous blood glucose levels of diabetic patients. The systems also have a memory module to determine dose levels based on analyte concentration in body fluid. There are also novel systems for insulin therapy. Medtronic holds 5 patents relating to glucose level insulin and catheters. The catheters have a flexible loop that acts as a holder for guide wires in surgery. Light-emitting: Some of the companies that have published patents in this peak are Massimo Inc, Philips, and Abbot Diabetes Care. These companies have no more than 2 patents families in the peak. The rest of the patenting activity is by individuals. The novelty of the patents is optical sensors that may be contact or non-contact for measuring temperature and monitoring bodily function of human Patient Parameters: The patented technologies are largely integrated electronic health monitoring systems that communicate with each other. They collect patient health parameters, such as ECG, and record, access, and manage patient records via databases, computer desktops, servers or global networks. The main players are Medtronic and Philips (12 patented docs), Cardiac Pacemakers and GEN Electric (8), Health Hero Networks (7), Siemens (6) Image Diagnostics: The main players patenting in image diagnostic technologies are Philips (14 patents), Siemens (10), GEN Electric (8). The novelty of the patented technologies diagnostic MRI data acquisition, internet-based interactive imaging system, Other companies with interests in remote Health IT include: Bosch Healthcare, Wireless Life Sciences Alliance, Telehealth Solutions, and Qualcomm who have fewer than 15 patents spread across the landscape. Selected patented documentations in recent years relating to the highlighted regions are listed in the Tables (See Appendix B, Tables 3, 4 and 5). 5. Discussion The market and IP landscape for information driven healthcare was studied in detail. The structured documentation in patent assignees/inventors, location, publication date gives valued insight in the promising emergence and development of technology in Health IT.

18 18 The trends in patenting activity are also associated with patent protection in different geographical scopes, which may reflect on the market coverage of a novel invention. The 2804 patent families suggest a trend towards a more spread out activity across the world. This is consistent with the data and suggests that patenting of Health IT technologies correlates with the respective national market size and overall economic level of development. Many healthcare industry leaders seek to innovate and aggressively expand growth in their respective sectors. As is evident on the graphs (Figure 6), the United States has a dominant position in Health IT and diagnostic monitoring systems. Most of the companies have also originated from the US; hence the tendency to file patents within the region. Likewise patentees also consider Europe as a viable commercial market for distribution and utilization of technologies related to Health IT. Information technology patenting is also being driven by specialists in technology and companies that have a focus on patenting IT. The landscape map also showed amongst the big firms, an increasing amount of individuals who owned patent rights within the field. The strength of Philips portfolio appears to lie in areas that are essential to the healthcare provider and patient, monitoring and display technologies, image diagnostics at the interface between software and hardware. This is certainly an area in which Philips has made significant innovations and may well represent a strategic sweet spot in Health IT. Firms might lose out if they try to pursue the technologies that are protected by a large portfolio of patents. This might be the case for patent portfolios in glucose and diabetes monitoring, which Abbott Care Diabetes holds a cluster of patents. While Abbott s portfolio is smaller, it has significant concentrations of patents in the critical region between the Philips, Siemens, GE- dominated diagnostic monitoring zone. From the maps, there are patented technologies that are spread out. This may suggest an opportunity to license and enter into partnerships through licensing agreements. If we consider a novel technology such as cardiac implantable, the patent numbers are limited to around 118 document families. Out of which the top assignee is Cardiac Pacemaker. Within that field, for a company, such as Medtronic which is not far off from matching Cardiac Pacemaker s filings, one option to increase its patent holdings might be to approach, individual inventors or smaller firms who possess certain core and/or compatible technologies. Of note-bearing was the growth in university patenting. Continuous scientific research meant that universities were identifying their IP, identified the value of their findings and applied for patent rights. The patent landscape also showed regions of small patent owner holdings portfolio. No one Health IT firm can hope to stay on top of the changing field. It is simply not cost effective. As such, opportunities for collaborative research can be furthered upon with some of the patents having narrow focused claims. A partnership could be established in an open innovation model. Approaches such as patent pools, open innovation or product development partnerships can be used in implementing an IP strategy towards speeding up development and deployment. Mergers and Acquisition could also accelerate development. Open innovation has led to a radical departure from the traditional model of closed, in-house innovation. Where it is treated as an open system, open innovation attempts to create new sources of ideas and solutions with the potential of influencing every aspect of business activity 23. With patent landscapes providing detailed technological, know-how and legal information, they can aid open innovation by making efficient, strategic and informed 23 Blackwell, K. D. Open Innovation: Facts, Fiction, and Future. (2008). One Technology Drive Tolland, USA. Connecticut, USA: Nerac Inc

19 19 decisions. The visualised trends on the Themescape maps showed areas of congested patent holdings. It does not necessarily reflect an inability to work in this area due to overlapping patent rights. It may also reflect narrow claims. In addition, a single patent may be as restrictive as a thicket of patents depending on the patent's claims 24. Further analysis of the patent claims would need to be conducted to determine breadth of patent rights. Theoretically, the benefits of health information technology in delivering a full set of choices for patient care are clear. However, notwithstanding the benefits of health informatics technologies, barriers to its implementation exist. These are usually the costs in acquiring technology and other complexities which often necessitates the adoption of new work processes and cultural changes 25. The challenge for the valuation of patents is that, often there is no history of successful commercialisation. Factors that may influence the value of patents include: legal/economic/protection/landscaping issues. In areas of crowded patent landscape, there is a possibility of a new competitor infringing rival patents. So the risk of patent litigation increases. With the expenses required, this becomes a serious threat to the existence of start-up companies or SMEs if they file lawsuits (they risk loosing revenues that they depend on) or if they are being sued (they risk huge amounts of payouts should they lose) 6. Conclusion Patent landscapes offer a plethora of information generates intelligence and highlights essential technologies, major patent holders, scientific and technical information, and knowhow. Health care will increasingly be an information-driven service. Continual novel innovations in Health Information Technology, including clinical decision support and health analytics, will further play an important role in enhancing delivery of healthcare in the future. As accessing and managing patient information becomes more vital in Health IT, communication and integrated diagnostic tools will enable remote access to patients from different locations. It is evident from the patent landscape, in Health IT, that there is an increasing growth in patent filing. A majority of filing seems to occur in integrated systems in diagnostic monitoring. Also, shown are that big companies tend to own various patents across regions. From the analysis, the big companies tend to file patents in the US, followed by Europe. Considering the UK alone, and other than GEN Electric, there is a lower dominance of big firms. The design and development of novel technologies depends on the core competence that a company possesses. This level of competency is what drives companies to patent, and possibly translate their patents to products; thus empowering their competitive position. 24 Clark, et al., Patent data mining: A tool for accelerating HIV vaccine innovation. Vaccine. 2011;29(24): Ash, et al., 2004

20 20 7. References Al-Shorbaji, N., Health and medical informatics. Cairo: World Health Organisation [updated: April 2001; cited: May 2012] Available from: Ash, J., Gorman, P., Seshadri, V., & Hersh, W., Computerized physician order entry in U.S. hospitals: results of a 2002 survey. J Am Med Inform Assoc, 2004;11:95-9. Berg, J. Healthcare Informatics into the 21st Century. UK: Business Insights Ltd Berwick, D. Escape Fire: Lessons for the Future of Health Care. New York: The Commonwealth Fund Blackwell, K., & Fazzina, D. Open Innovation: Facts, Fiction, and Future, One Technology Drive Tolland, USA. Connecticut, USA: Nerac Inc Blumenthal, D., & DesRoches, C. (Eds.). Health Information Technology in the United States: Where We Stand. USA: Robert Wood Johnson Foundation Byass, P. The Unequal World of Health Data. PLoS Med, 2009;6(11):1-3. Chaudhry, B., Wang, J., Wu, S., Maglione, M., Mojica, W., Roth, E., et al. Systematic Review: Impact of Health Information Technology on Quality, Efficiency and Costs of Medical Care. Annals of Internal Medicine, 2006;144:E-12-E-22. Clark, K., Cavicchi, J., Jensen, K., Fitzgerald, R., Bennett, A., & Kowalski, S. Patent data mining: A tool for accelerating HIV vaccine innovation. 2011;29(24): Flanders, E. The real meaning behind meaningful use. Radiographics, 2010;30: Groen, et al. (2008). Medical Informatics: Emerging Technologies, Open EHR Systems, and Ethics in the 21st Century. [Update 2008; Cited May 07, 2012]. Available from Harding, B. (2010) Healthcare Information Technology, Present Investment and Future Outlook in the American Healthcare Market. Institute for Health Technology Transformation. [Updated: 2010; Cited May 16, 2012]. Availiable from: Health, N. C. (2012) National Programme for IT in the NHS. [Updated 2012; Cited May 16, 2012]. Available from HHS, U. D. (n.d.). [Cited May 17, 2012]. Available from Kerr, K., & Norris, T. Improving Health Care Data Quality: A Practitioner's Perspective. International Journal of Information Quality, 2008;2(1): Markets and Markets. (2011). World Healthcare IT Market: Trends & Forecast ( ). [Cited May 14, 2012] Available from:

21 21 Moukheiber, Z. (2012). Forbes Midas List: The VCs Who Are Investing In Health IT. Update: 2012; Cited May 18, 2012]. Available from: Radiologists., T. R. (2008). Radiology Information Systems. London. Ranck, J. (2011). Health Information and Health Care: The Role of Technology in Unlocking Data and Wellness A Discussion Paper. [Updated: 2011; Cited May 16, 2012]. Available from: Tan, S., & Lewis, R. Picture archiving and communication systems: A multicentre survey of users experience and satisfaction. European Journal of Radiology, 2010;75: Telehealth and Smart Technology. (n.d.). [Cited May 17, 2012] Available from: The Wall Street Transcript. (2009, Aug 10). Investing in Healthcare IT. [Cited May 15, 2012]. Available from: Whitehouse, D. e-health making healthcare better for European citizens: An action plan for a European e-health area. IFIP International Federation for Information Processing, 2004;156:

22 22 8. Appendices 8.1. Appendix A General Applications OF Health IT Computer-based Medical Records The demand for a well structured, integrated and accessible patient data, combined with advances in IT has led to a great interest in Electronic Patient Records (EPRs). Such EPRs include pathology reports, charts, and diagrams. The medical record has its advantages in health care. These include: Concurrent access to medical contents from various locations by consultants, physicians and nurses Content legibility due to machine coded language Structured data entry support meaning that certain field have got to be completed before moving to a new data field; ensuring that records are complete and usable Viewing data in various forms and formats as data is electronically stored Decision-making support due to the ability to link data elements and generate new information Exchange of electronic data and sharing care support between hospitals; thus overcoming the advent of having to move paper files between locations Management, Epidemiological Surveillance, and GIS Management refers to support for health care activities, where it ranges from problem analysis, planning, monitoring, budgeting, and evaluation. It also takes into consideration the logistics, financial management of health care services. Other management applications may involve the management of national programmes or management of national health services. In epidemiological surveillance, the study of pattern distributions and trends, of say diseases and other health related issues, by age groups, geographical regions, etc does enable the establishment of priorities and optimisation measures through monitoring and evaluation. Health statistics and epidemiology are supported in part by telematics and informatics. Geographic Information Systems (GIS) is a controlled system compilation of IT hardware and software, geographic data, people and knowledge designed to, store, manipulate, update, analyse, and display spatial data. Furthermore, as an essential part of the health information system, they give visual presentation of statistical data with a clear link to geographic locations ehealth, Telemedicine, & Telehealth The drive for active healthcare improvement has had a knock-on effect in the field of ehealth an emerging market with possible strong growth for healthcare practice supported by electronic/digital processes and communication. Some of the emergence in ehealth has

23 23 focused on imaging modalities, where software and solutions have assisted in providing high output. Telemedicine defines the use of interactive audio, visual and data communication to deliver health services and information from one location to the other. It continues to be one of the attractions of health information systems. It has its advantages in reducing the number of visits to doctors and allowing patients to be treated at locations of their own choice. Telehealth applications are also been implemented to extend healthcare delivery to remote areas that have a limited number qualified resources. This application also supports healthrelated education, public health and health administration. The benefits of telehealth have been cited 26. Strides are being taken to integrate telemedicine data into EHR and PHR systems Knowledge-based Systems Knowledge-based or Decision Support Systems are recent areas of applications that are likely to expand with the input of more informatics support systems. They serve to provide advice on medico-scientific issues. The information management in this area consists of system, resources and services to: Help health workers acquire and maintain knowledge for patient care Support clinical decision making and educate patients Support improvement of performance Wearable Intelligent Technology Systems (WITS) These are remote, digital and mobile technologies that integrate with other systems so to collect, access, and mange patient information. Such systems generate smart EHRs where they monitor patient vital signs, communicate wirelessly, and monitor progress of surgery from outside the operating room using palm held devices. The availability of medical sensors, the glucose counter, and insulin delivery system are some of the technologies that have enhanced healthcare delivery Imaging Systems The use of digital imaging systems, particularly in radiology to improve efficiency and communication, is expanding worldwide (Fig 8). Also an evolution of radiology toward electronic and digital management of images has allowed the healthcare department to be more efficient, reduce operating costs, and improve the communication between radiologists and the referring physician Picture Archiving Communication Systems (PACS) PACS is a medical imaging technology which provides economical storage of, and convenient access to images from multiple modalities such as MRI, CT and X-ray. Its 26 Accessed May Groen, Mahootian, & Goldstein. Medical Informatics: Emerging Technologies, Systems, and Ethics in the 21 st Century 2008 Open EHR

24 24 usefulness is in eliminating the need to manually file, retrieve or transport film jackets and allowing a multitude of modalities to be available via one digital communication system. In doing so, it provides a strong foundation for advanced medical therapies in telehealth and telemedicine. In their survey, Tan & Lewis (2008) 28 concluded that PACS systems were generally very well accepted by clinicians. A study of orthopaedic surgeons reported that 1 year of PACS implementation, 100% would recommend a PACS, 92% saw a reduction in time required to receive image and 64% concluded that patient care was faster. Philips has been continually expanding its PACS system worldwide with North America, Europe and Japan account for 80% of the total PACS market (Fig 8) Radiology Information System (RIS) Designed in a very flexible and easy way, RIS is a fully integrated electronic web-based management application implemented in hospitals/clinics. With its integration with PACS, it is largely used as a store of patient images, scans, and ECG graphs and contributes to EPRs 29. Figure 8 Philips PACS worldwide installed base. Over 1800 PACS systems for Radiology and/or Cardiology installed worldwide. Dots give indication of installation of one ore more radio and/or cardio PACS system (Adapted from Muduroglu, 2007) Tan, S., & Lewis, R., Picture archiving and communication systems: A multicentre survey of users experience and satisfaction. European Journal of Radiology. 2010;75: The Royal College of Radiologists. Radiology Information Systems. London: The Royal College of Radiologists. (2008) Ref No. BFCR (08) 6 30 Muduroglu, O., Healthcare-Informatics-(3.7Mb) pdf