Wikipedia:WikiProject Council/Proposals/Global mHealth Standardization Initiative
- 1 Description
- 2 Project Information
- 3 Policies and Procedures
- 4 Content Submission
- 5 Ownership, Management & Maintenance
- 6 License & Requirements
- 7 RDF Dumps
- 8 Editor Removal Procedures
- 9 Content Users
- 10 mHealth Sectors
- 11 Regulatory Agency Enforcement of mHealth
- 12 References
- 13 External Links
The "Global mHealth Standardization Initiative (GMHSI)" is utilizing an open source, publically accessible multilingual multilateral open content directory serving as a consensus driven user platform to converge & regionally categorize global open standards for mHealth technologies.
The GMHSI mHealth open standards development process combines hierarchical common logic ontology engineering computational modeling of collected intelligence with collaborative transparent consensus-based assessment and due process to evaluate, establish, approve, and maintain mHealth open standards development. This initiative requires active participation & cooperative information sharing between multisectoral public / private industry, academia, multilateral regulatory agencies responsible for establishing and enforcing regulatory compliance over medical device development, consumer protection of protected health information legislation, and laws, and standards organizations responsible for developing technical specification interoperability standards between multiple data architectures and standards to support wireless exchanges of health records.
The Global mHealth Standardization Initiative is a global collaborative consensus driven process of Global mHealth open standards development. The Global mHealth Standardization Initiative Portal serves as the project's open access collaborative workspace for GMHSI's virtual community, multilateral multiagency standards & requirements submission hub, and computational modeling results publication repository which is continuously updated & maintained to identify, measure and publish current interagency duplication of efforts or gaps requiring new legislation, regulations, and standards,. Importantly, the portal serves as the platform for transparent non discriminatory interagency collaboration in the examination, convergence, and harmonization of existing standards & open standards, best practices, and policies that reinforce each other, and can be aligned, expanded and further developed into sustainable scalable Global mHealth Open Standards.
Policies and Procedures
GMHSI Open Standards Development
- due process is public, and all computational modeling results, reports & technical recommendations , are archived and referencable for decision making.
- anybody can participate, industry, individual, public, government bodies, standards organizations, academia, on a global scale.
- guaranteed impartiality, consensus,and fairness by the process and the neutral hosting by the IMHSC organization.
- free access to the standard text, both during development and at final stage, translations, and clear rules for open source mHealth standards development.
- ongoing process for testing, errata, revision, and permanent access.
- open Standards fully support vendor neutrality.
- open standards are free for all to implement, with no royalty or fee.
- participating organizations must provide a path for low and zero-cost implementations.
- implementations of open standards may be extended.
- International regulatory flexibility initiatives, policies, procedures, requirements & guidelines
- Multisectored Standards
- Technical convergence and configuration management standards
- legislation, policies and cyberlaws
- ethics of technology, medical ethics, and file sharing ethics
Ownership, Management & Maintenance
License & Requirements
Editor Removal Procedures
Telemedicine,eHealth,Medical Devices,Telecommunications,Life Sciences,Federal Government,Foreign Governments,Information Technologies,biometrics,Teleradiology,Wireless,public health policy, consumer protection agencies,Health Informatics, Health Information Management,translational bioinformatics
Regulatory Agency Enforcement of mHealth
Federal Government Regulations Relevant to mHealth
- HIPAA 1996 Health Insurance Portability and Accountibility Act
- 1999 Gramm-Leach-Bliley Act
- 2002 Homeland Security Act (includes the Federal Information Security Management Act FISMA
State Government Regulation
US Federal Government Agency Oversight of mHealth
- FDA CDRH Center for Devices and Radiological Health - division of the FDA oversees the premarket approval and the post-marketing device safety monitoring of all medical devices. CDRH oversees the safety and performance of all non-medical devices emitting electromagnetic radiation such as cellular phones, airport screening & imaging equipment, and television receivers. FDA computerized systems used in clinical trials, HIPAA, Code of Federal Regulations, electronic signatures, electronic informed consent, medical device development, manufacturing, and distribution.
- FTC Federal Trade Commission
- FCC Federal Communications Commission
- HHS Health and Human Services - Office for Human Research Protections
- FEMA Federal Emergency Management Agency
- DOD Department of Defense
- DHS 2003 National Strategy to Secure Cyberspace placed responsibility on the Department of Homeland Security for researching and making security recommendations.
- CDC Centers for Disease Control
Legislation Affecting mHealth
- Fair Packaging & Labeling Act 1962
- Medical Device Regulation Act 1977
- Dietary Supplement Health and Education Act 1994
- Food and Drug Modernization Act 1997
- Bioterrorism Act 2002
- Medical Device User Fee Modernization Act MDUFMA 2002
Catogorized Global List of mHealth Relevant Standards Organizations
Global Internet & CyberSecurity Standards Organizations
- BSI British Standards Institute
- ISA International Society of Automation
- NIST National Institute for Standards & Technology
- ISO International Organization for Standardization - ISO/IEC JTC 1
- IEC International Electrotechnical Commission
- ISF Information Security Forum (Standard of Good Practice)
- NERC North American Electric Reliability Corporation
- IETF Internet Engineering Task Force
- W3C World Wide Web Consortium
Telecommunications Standards Organizations
- ITU International Telecommunication Union
- ITSO International Telecommunications Satellite Organization
- IMSO International Mobile Satellite Organization
- IAEA International Atomic Energy Agency
- China SFDA State Food and Drug Administration of China
- Department of Medical Devices
- Department of Drug Regulation
- Department of Drug Safety and Inspection
Ministry of Science and Technology Depending on the product being exported to China, a company may need to register with the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China AQSIQ. China's State Quality Control Administration enacts and implements national standards.
- Hong Kong MDCO Medical Device Control Office which is part of the Department of Health and Pharmaceutical Service PSDH. Hong Kong has it's own set of unique medical device regulations that differ from China.
- India Board of Radiation and Isotope Technology BRIT, Central Drug Standards Control Organization CDSCO is headed by the Drug Controller General of India DCGI. CDSCO regulates drugs, diagnostics, devices, and cosmetics, and also is responsible for the safety, efficacy, and quality standards for pharmaceuticals and medical devices. DCGTI is advised by the Drug Technical Advisory Board DTAB and the Drug Consultative Commission DCC. All licenses for medical devices are handled by the Central Licensing Approval Authority CLAA. State governments are responsible for licensing, approvals, inspection, and recalls, of drugs manufactured within their domain.
- Japan The main regulatory body for creating laws and standards for medical devices and drugs in Japan is the Ministry of Health, Labour and Welfare (Japan) MHLW. Under the MHLW is the Pharmaceutical and Food Safety Bureau. This bureau is in charge of setting pharmaceutical and medical device regulatory policy.
- Korea KFDA The Korean Food and Drug Administration resembles the FDA of the United States. It was established in 1998 and regulates foods, pharmaceuticals, medical devices and cosmetics. The KFDA is divided into five bureaus, including the Pharmaceutical Safety Bureau and the Medical Device Safety Bureau. These bureaus hold primary responsibility for pharmaceutical and medical device regulations. In addition to its main office in Seoul, the KFDA also has six regional offices that serve as field operational bases.
- Malaysia MOH Ministry of Health
- Philippines DOH
- Singapore HSA
- Taiwan TFDA
- Thailand FDA
- Vietnam MOH Ministry of Health
Healthcare Informatics Interoperability
- HL7 Health Level 7
- CEN European Committee for Standardization
- CENELEC European Committee for Electrotechnical Standardization
Clinical Informatics Interoperability
- CDISC Clinical Data Interchange Consortium
VentureBridge 04:53, 3 February 2011 (UTC)
Please specify whether or not you would join the project.
- VentureBridge 04:53, 3 February 2011 (UTC)