| Globalization and Health | |
| Developing global health technology standards: what can other industries teach us? | |
| Karen Bartleson1  Rebecca Lackman3  Hassan Masum2  | |
| [1] Synopsys, Inc, 700 East Middlefield Road, Mountain View, CA 94043, USA;Sandra Rotman Centre, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto, ON M5G 1L7, Canada;Grand Challenges Canada, 101 College Street Suite 406, Toronto, ON M5G 1L7, Canada | |
| 关键词: Diagnostics; Modularity; Interface; Affordability; Interoperability; Standards; Global health; | |
| Others : 805319 DOI : 10.1186/1744-8603-9-49 |
|
| received in 2013-02-14, accepted in 2013-09-10, 发布年份 2013 | |
PDF
|
|
【 摘 要 】
Background
There is a lack of effective and affordable technologies to address health needs in the developing world. One way to address problems of innovation and affordability is to design global health technologies to follow agreed-upon standards. This Debate article argues that we can better develop standards for global health technologies if we learn lessons from other industries.
Discussion
The article’s Background section begins by explaining why standards are needed in global health. For example, if global health technologies can be modularized into independent interfacing parts, these parts can then interact via well-defined standards in a “plug and play” fashion. This can avoid development of mutually incompatible solutions by different organizations, speed the pace of innovation, unlock health systems from single providers and approaches, and lower barriers to entry. The Background then gives a brief primer on standards and discusses incentives for health standards. The article’s Discussion section begins with brief relevant cases of standards development from other industries, including electricity, container shipping, CD standards, Universal Serial Bus (USB), and the Internet. It then explores lessons from these and other industries that suggest how to develop standards for global health technologies. The remainder of the Discussion considers intellectual property and regulatory issues and standards-based global health business models, and ends with a checklist of considerations for health standards development leaders. (The associated Additional file discusses observations from standards development for cell phones and semiconductors, as well as challenges in the standards development process itself.) Throughout the article, point-of-care diagnostics are used as an illustrative example. An initiative is already underway to explore standardized diagnostics platforms.
Summary
This Debate article aims to convince the reader that standards can benefit global health technologies if we learn lessons from other industries. The article draws from historical examples and the authors’ experiences to suggest principles, challenges, and opportunities in developing these standards. If implemented well, standardized platforms can lower barriers to entry, improve affordability, and create a vibrant ecosystem of innovative new global health technologies.
【 授权许可】
2013 Masum et al.; licensee BioMed Central Ltd.
【 预 览 】
| Files | Size | Format | View |
|---|---|---|---|
| 20140708074752336.pdf | 252KB |
【 参考文献 】
- [1]World Health Organization: Compendium of new and emerging health technologies. Geneva, Switzerland; 2011.
- [2]World Health Organization: Medical devices and eHealth solutions: Compendium of innovative health technologies for low-resource settings. Geneva, Switzerland; 2012.
- [3]BIO Ventures for Global Health: Developing New Drugs and Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape. San Francisco, CA; 2012.
- [4]Howitt P, Darzi A, Yang GZ, Ashrafian H, Atun R, Barlow J, Blakemore A, Bull AM, Car J, Conteh L, Cooke GS, Ford N, Gregson SA, Kerr K, King D, Kulendran M, Malkin RA, Majeed A, Matlin S, Merrifield R, Penfold HA, Reid SD, Smith PC, Stevens MM, Templeton MR, Vincent C, Wilson E: Technologies for global health. Lancet 2012, 380(9840):507-535.
- [5]Global Health Technologies Coalition and Policy Cures: Saving lives and creating impact: Why investing in global health research works. Washington, DC; 2012.
- [6]Free MJ: Achieving appropriate design and widespread use of health care technologies in the developing world. overcoming obstacles that impede the adaptation and diffusion of priority technologies for primary health care. Int J Gynaecol Obstet 2004, 85(Suppl 1):S3-S13.
- [7]BVGH (BIO Ventures for Global Health): The Diagnostics Innovation Map: Medical Diagnostics for the Unmet Needs of the Developing World. Washington, DC; 2011.
- [8]Singer PA, Berndtson K, Shawn Tracy C, Cohen ERM, Masum H, Daar AS: A Tough Transition. Nature 2007, 449(7159):160-163.
- [9]Benatar S, Brock G: Global Health and Global Health Ethics. Cambridge, UK: Cambridge University Press; 2011.
- [10]Bissonnette L, Bergeron MG: Diagnosing infections–current and anticipated technologies for point-of-care diagnostics and home-based testing. Clin Microbiol Infect 2010, 16(8):1044-1053.
- [11]Pai NP, Vadnais C, Denkinger C, Engel N, Pai M: Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low- and middle-income countries. PLoS Med 2012, 9(9):e1001306.
- [12]Chan CP, Mak WC, Cheung KY, Sin KK, Yu CM, Rainer TH, Renneberg R: Evidence-based point-of-care diagnostics: current status and emerging technologies. Annual Rev Anal Chem 2013, 6(1):191-211.
- [13]Pai NP, Pai M: Point-of-care diagnostics for HIV and tuberculosis: landscape, pipeline, and unmet needs. Discov Med 2012, 13(68):35-45.
- [14]Hutson S: To save lives, initiative pushes for standardized diagnostic tools. Nat Med 2010, 16:11.
- [15]Greenstein S, Stango V: Standards and Public Policy. Cambridge, UK: Cambridge University Press; 2007.
- [16]Blind K: The economics of standards: theory, evidence, policy. Cheltenham, UK: Edward Elgar Publishing; 2004.
- [17]Swann P: The Economics of Standardization. Final Report for Standards and Technical Regulations Directorate, Department of Trade and Industry, U.K. UK: Department of Trade and Industry; 2000.
- [18]Swann P: The Economics of Standardization: An Update. Report for the U.K. Department of Business, Innovation and Skills (BIS), UK, Version 2.2. U.K. UK: Department of Business, Innovation and Skills; 2010.
- [19]DIN: German Institute for Standardization e. V. Berlin: Economic Benefits of Standardization: Summary of Results; 2000.
- [20]Blind K, Jungmittag A: The impact of patents and standards on macroeconomic growth: a panel approach covering four countries and 12 sectors. J Product Anal 2008, 29(1):51-60.
- [21]U.K. Department of Trade and Industry: The Empirical Economics of Standards, Volume 12. UK: DTI Economics Paper; 2005.
- [22]Haimowitz J, Warren J: Economic Value of Standardization. Canada: The Conference Board of Canada; 2007.
- [23]Reynolds CJ, Wyatt JC: Open source, open standards, and health care information systems. J Med Internet Res 2011, 13(1):e24.
- [24]Fioretti M: Why Open Digital Standards Matter in Government. In Open Government: Collaboration, Transparency, and Participation in Practice. Edited by Lathrop D, Ruma L. Cambridge, MA: O'Reilly Media; 2010:363-374.
- [25]British Standards Institution: What is a Standard?. [http://www.bsigroup.com/en-GB/standards/Information-about-standards/what-is-a-standard/ webcite]
- [26]Siva N: Tackling the booming trade in counterfeit drugs. Lancet 2010, 376(9754):1725-1726.
- [27]Egyedi TM, Blind K: The Dynamics of Standards. USA: Edward Elgar Publishing; 2008.
- [28]Bos B: What is a good standard?. [http://www.w3.org/People/Bos/DesignGuide/introduction webcite]
- [29]Krattiger AF: Intellectual property management in health and agricultural innovation: a handbook of best practices. Oxford, UK: MIHR, PIPRA; 2007.
- [30]Masum H, Harris R: Open Source for Neglected Diseases: Magic Bullet or Mirage?. Washington, D.C.: Results for Development Institute; 2011.
- [31]Masum H, Schroeder K, Khan M, Daar AS: Open source biotechnology platforms for global health and development: two case studies. Info Technol Int Dev 2011, 7(1):61-69.
- [32]West J: Seeking open infrastructure: contrasting open standards, open source and open innovation. First Monday 2007., 12(6)
- [33]Martinez I, Escayola J, Trigo JD, Garcia J, Martinez-Espronceda M, Led S, Serrano L: Recent innovative advances in telemedicine: standard-based designs for personal health. Int J Biomed Eng Technol 2011, 5(2):175-194.
- [34]Benson T: Principles of Health Interoperability: HL7 and SNOMED. 2nd edition. London, UK: Springer; 2012.
- [35]Williams C, Mostashari F, Mertz K, Hogin E, Atwal P: From the office of the national coordinator: the strategy for advancing the exchange of health information. Health Aff 2012, 31(3):3527-3536.
- [36]Kush RD: Data sharing: electronic health records and research interoperability. In Clinical Research Informatics. Edited by Richesson RL, Andrews JE. London, UK: Springer; 2012:313-333.
- [37]Hammond WE, Richesson RL: Standards Development and the Future of Research Data Sources, Interoperability, and Exchange. In Clinical Research Informatics. Edited by Richesson RL, Andrews JE. London, UK: Springer; 2012:335-365.
- [38]Gliklich RE, Dreyer NA: Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville, MD, USA: Agency for Healthcare Research and Quality (US); 2010. Appendix C, Relevant Entities in Health Information Technology Standards
- [39]Levinson M: The Box: how the shipping container made the world smaller and the world economy bigger. Princeton, NJ: Princeton University Press; 2006.
- [40]Murphy CN, Yates J: The International Organization for Standardization (ISO): global governance through voluntary consensus. London, UK: Routledge; 2009.
- [41]Gawer A, Cusumano MA: Platform Leadership. Boston, MA: Harvard Business School Press; 2002.
- [42]McNichol T: AC/DC: The Savage Tale of the First Standards War. San Francisco: Jossey-Bass; 2006.
- [43]Schewe PF: The grid: a journey through the heart of our electrified world. Washington, DC: J. Henry Press; 2007.
- [44]NIST Smart Grid Homepage. [http://www.nist.gov/smartgrid/ webcite]
- [45]Fisher DE, Fisher MJ: The color war. American Heritage's Invention and Technology Magazine 1997, 12(3):8-19.
- [46]Immink KAS: The CD story. J Audio Eng Soc 1998, 46:458-465.
- [47]Zittrain J: The Future of the Internet. New Haven, CT: Yale University Press; 2009.
- [48]Jakobs K: Even much needed standards can fail - the case of e-mail. J Comm Net 2006, 5(1):93-99.
- [49]Lampland M, Star SL: Standards and Their Stories. Ithaca, NY: Cornell University Press; 2009.
- [50]Russell A: Standardization in history: a review essay with an eye to the future. In The Standards Edge: Future Generations. Edited by Sherrie B, Ann A. MI: Sheridan Press; 2005:247-260.
- [51]Hatcliff J, King A, Insup L, Macdonald A, Fernando A, Robkin M, Vasserman E, Weininger S, Goldman JM: Rationale and architecture principles for medical application platforms. In proceedings of the 2012 IEEE/ACM third international conference on cyber-physical systems: 17–19 April 2012; Beijing, China. IEEE 2012, 3-12. DOI: 10.1109/ICCPS.2012.9
- [52]Masum H, Shah R, Schroeder K, Daar AS, Singer PA: Africa's largest long-lasting insecticide-treated net producer: lessons from A to Z Textiles. BMC Int Health Hum Rights 2010, 10(Suppl 1):S6. BioMed Central Full Text
- [53]Shapiro C, Varian HR: The Art of Standards Wars. In Managing in the Modular Age. Edited by Garud R, Kumaraswamy A, Langlois RN. Oxford, UK: Blackwell Publishers; 2003:247-272.
- [54]Smith ZJ, Chu K, Espenson AR, Rahimzadeh M, Gryshuk A, Molinaro M, Dwyre DM, Lane S, Matthews D, Wachsmann-Hogiu S: Cell-phone-based platform for biomedical device development and education applications. PLOS One 2011, 6(3):e17150. DOI: 10.1371/journal.pone.0017150
- [55]WHO Global Observatory for eHealth: New horizons for health through mobile technologies. Geneva, Switzerland: World Health Organization; 2011.
- [56]Topol E: The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York, NY: Basic Books; 2012.
- [57]IOM (Institute of Medicine): Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development: Workshop Summary. Washington, DC: The National Academies Press; 2011.
- [58]Masum H, Ranck J, Singer PA: Five promising methods for health foresight. Foresight Journal 2010, 12(1):54-66.
- [59]Palamountain KM, Stewart KA, Krauss A, Kelso D, Diermeier D: University leadership for innovation in global health and HIV/AIDS diagnostics. Glob Public Health 2010, 5(2):189-196.
- [60]CLSI: Standards Activities. [http://www.clsi.org/standards/ webcite]
- [61]Hindler JF, Stelling J: Analysis and presentation of cumulative antibiograms: a new consensus guideline from the clinical and laboratory standards institute. Clin Infect Dis 2007, 44(6):867-873.
- [62]Clinical and Laboratory Standards Institute: Clinical and Laboratory Standards Institute Administrative Procedures. Wayne, PA: ; 2011.
- [63]Lemley MA: Intellectual property rights and standard-setting organizations. California Law Review 2002, 90:1889-1980.
- [64]Simcoe T: Open Standards and Intellectual Property Rights. In Open Innovation: Researching a New Paradigm. Edited by Chesbrough H, Vanhaverbeke W, West J. Oxford, U.K: Oxford University Press; 2006:161-183.
- [65]Netanel NW: The Development Agenda: Global Intellectual Property and Developing Countries. Oxford, UK: Oxford University Press; 2009.
- [66]World Health Organization: Public health, innovation and intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva, Switzerland: ; 2006.
- [67]Boyle J: The Public Domain: Enclosing the Commons of the Mind. New Haven, CT: Yale University Press; 2008.
- [68]Van Overwalle G: (Ed): Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes. Cambridge, UK: Cambridge University Press; 2009.
- [69]IP Handbook of Best Practices: Specific Strategies and Mechanisms for Facilitating Access to Innovation. [http://www.iphandbook.org/handbook/ch02/ webcite]
- [70]Zirpoli F, Becker MC: The limits of design and engineering outsourcing: performance integration and the unfulfilled promises of modularity. R&D Manag 2011, 41(1):21-43.
- [71]Webb K: Voluntary Codes: private governance, the public interest and innovation. Ottawa, Canada: Carleton Research Unit on Innovation, Science, and Environment; 2004.
- [72]Masum H, Tovey M: The Reputation Society: how online reputation is changing the offline world. Cambridge, MA: MIT Press; 2012.
- [73]Schneier B: Schneier on security. Indianapolis, IN: Wiley Publishers; 2008.
- [74]Moran M, Guzman J, Henderson K, Liyanage R, Wu L, Chin E, Chapman N, Abela-Oversteegen L, Gouglas D, Kwong D: G-FINDER 2012: Neglected Disease Research & Development: A Five Year Review. Sydney, Australia: Policy Cures; 2012.
- [75]Urdea M, Penny LA, Olmsted SS, Giovanni MY, Kaspar P, Shepherd A, Wilson P, Dahl CA, Buchsbaum S, Moeller G, Hay Burgess DC: Requirements for high impact diagnostics in the developing world. Nature 2006, 444(Suppl 1):73-79.
- [76]Gawande A: The Checklist Manifesto: How to Get Things Right. New York, NY: Metropolitan Books; 2010.
- [77]Bartleson K: The Ten Commandments for Effective Standards: Practical Insights for Creating Technical Standards. Mountain View, CA: Synopsys Press; 2010.
PDF