| ||Universal mHealth Charter UMHC|
Detailed Universal mHealth Process for Collaboration, Data Collection & Analytics. Draft for Comment UMHDP
Universal mHealth Standardization Forum Standards / Regulation Contributions & Intiatives Dashboard UMHD
Universal mHealth Quality, Compliance & Auditing Program Development Guidance UMHQPD
Universal mHealth Quality, Compliance & Training Program Implementation Templates UMHIT
Universal mHealth Auditing Program Development Guidance UMHAG
Universal mHealth Auditing & Training Program Implementation Templates UMHAIT
Universal mHealth Certification Program UMHCP
mHealth innovation converges data exchange between EMR/EHR's, clinical informatics, wireless mobile devices, and the Internet all of which are heavily regulated by multilateral global agencies responsible for enforcing legislation and guidelines. |
A large majority of mHealth innovators have computer science and technical backgrounds, and while familiar with software / hardware engineering, FTC/ FCC regulations and applicable standards, many are unaware how heavily regulated and different the health IT space is. Until mHealth technology emerged, electronic medical records, and health systems had regulatory oversight by separate agencies and applicable standards (HHS oversight,HL7 standards) than computerized systems used in clinical trials such as electronic data capture (EDC), electronic trial master files (eTMF) and eRegulatory Systems (FDA oversight,CDISC standards).
All regulatory agencies listed above mandate that standard operating procedures (SOP) mapped to industry standards and regulatory requirements has to exist and be documented for every step of the software development lifecycle (SDLC) and all operational business processes, procedures, training, and workflow. Additionally, documentation has to exist to prove that these specified requirements were followed.
There are additional regulations and standards requirements placed on mHealth companies if hosting or data warehousing any data exchange containing personal health information (PHI) or a if medical device is part of the mHealth technology product offering a complete new set of dynamic regulatory requirements and standards apply that differ in each Country.
While overlap of oversight occurs between US government agencies responsible for overseeing and enforcing mHealth technology sectors, once you know who they are, it's fairly easy for mHealth innovators to access and navigate the websites of the various agencies and access, identify and download regulatory requirements and guidelines applicable to mHealth. The same goes for regulatory agencies outside the US (OUS) Most of the sites have incorporated RSS feeds allowing mHealth innovators to be apprised of any changes or new requirements.
It's imperative that mHealth innovators perform regulatory and standards requirements due diligence while still in the product development commercialization planning stage, and certainly prior to actually developing an mHealth technology or application as the regulatory requirements will have a direct impact on the functional specifications, manufacturing, target market sector and commercialization plans, and business operational processes.
Why is this important? Because regulatory agencies audit.
If regulatory agencies site major findings of deviations from requirements they will recall your mHealth app and/or product.
The regional and local expertise of standards organizations on a global scale are critical to the accelerated development of Global mHealth Open Standards. Although, for standards organizations who don't typically offer published openly available standards without membership, participation in an Open Standards development initiative might be considered challenging however, standards pertaining to mHealth constitute segmented and specific sets of applicable standards which could be submitted
Additionally, As regulatory and standards experts it is our responsibility to ACT. Just as our Commander in Chief so eloquently stated "What is required of us is a new era of responsibility. We must recognize that we have duties to ourselves, our nation, and the world." It's a fact that commercialized mHealth applications are being sold and actively used that are exchanging personal health data (PHI) hosted and warehoused on company servers without the required quality and regulatory programs, procedures, and documentation needed to be in compliance.
Just as regulatory agencies will hold both small and large mHealth technology corporations accountable for regulatory and standards deviations. As regulatory and standards experts, we are just as accountable in protecting the privacy of personal health information exchange, ensuring consumer and patient safety, and we must unite in an expedited global collaborative effort to provide mHealth innovators with standards, tools and guidance they need to integrate corporate and regulatory responsibility into their foundation to remain viable, drive shareholder value, and sustain innovation.
IMHSC recognizes that Global mHealth Open Standards mapped to regulatory requirements are required to protect the privacy of personal health information and to support and sustain mHealth technology innovation, adoption & implementation.
Since most global standards organizations have their information and publicly available standards published on Wikipedia IMHSC considers Wikipedia as the logical platform and as the central Polylinguistic repository for the analytical review, gap analysis and collaboration for the development and publishing of International mHealth Open Standards.
Phase One - Call to Action
IMHSC calls for worldwide convergence and open participation including individuals, public, and private industry, standards organizations, government, and non government regulatory agencies to select a member representative to continuously update standards, policies, legislation, cyberlaws, requirements, and best practice recommendations on Wikipedia.
SA - Standards Australia Through a Memorandum of Understanding with the Australian government SA is recognized as the peak non-government standards development in Australia. SA Wiki
The UK government recently issued a procurement policy note Here
taking a clear stance on openness and interoperability and requiring to
reference open standards in public tenders whenever possible.
In this way the UK procurement policy
exactly prescribes what is needed in the area of eGovernment services
and software interoperability where Open Source software plays an
important role. The open standards policy allows the integration of Open
Source on equal footing with proprietary offerings.
Open standards are also
a key element for service orientation and promoting innovation and
choice and fostering competition. Open Standards provide a level basis
on which to innovate. They allow everyone to compete fairly and on equal
terms with new or better products and offerings. And they allow the
seamless integration of technologies into an open architecture thus
providing the space for innovative technologies and products to be made
available to and driven by public authorities.
ARIB (Association of Radio Industries and Businesses) ARIB is a standardization organization in Japan designated as the center for promotion of the efficient use of the radio spectrum and designated frequency support agency. ACIB's activities include those previously performed by RCR Research & Development Center for Radio Systems and BTA Broadcasting Technology Association. ARIB Wiki
TTC Telecommunication Technology Committee TTC is a standardization organization authorized by Japan's Ministry of Internal Affairs and Communications to conduct research and promote standards for telecommunications in Japan. TTC Wiki
AAMI (Association for the Advancement of Medical Instrumentation) AAMI is a voluntary consensus organization which promotes knowledge and use of medical instrumentation. AAMI creates standards, educates and certifies technicians, and publishes technical documents, books, and software.
AAMI Wiki www.aami.org
AIUM (American Institute of Ultrasound in Medicine) AIUM Wiki
ANSI (American National Standards Institute) ANSI Wiki
ASME (American Society of Mechanical Engineers) ASME Wiki
ASQ (American Society of Quality) ASQ Wiki
ESD (Electrostatic Discharge Association)
IEEE (Institute of Electrical & Electronic Engineers) IEEE
US FDA CDRH Standard Operating Procedures for the "Identification and Evaluation of Candidate Consensus Standards for Recognition" September 17, 2007
FDA Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program May 20, 2010
FDA Actions RFID (Radio-Frequency Identification)
FDA Recognized Standards
Guidance to Industry & for FDA Staff Standards Substantial Equivalence Determinations
Have standards recommendation for FDA? Submission Process Here
TIA (Telecommunications Industry Association) TIA is a global trade association that creates universal networking and education standards for the telephony,data networking, and convergence industry. TIA networking standards have been used worldwide including commercial grounding - earthing standards, fiber optic color coding, and telecommunications cabling standards, used by nearly all voice, video and data networks. TIA Wiki
CCSA China Communications Standards Association CCSA Wiki
European Standards Organizations & Standards
Broadband Wireless Access Standards Click on Standards
CEN Wiki (European Committee for Standardization) CEN
CENELEC European Commission Innovation Policy Standardization Mandate M/376 to CEN, CENELEC and ETSI - European Committee for Electrotechnical Standardization CENELEC Wiki
eHealth Information & Communications Standards EMC ElectroMagnetic Compatibility Standards - Access by Clicking on Standards
Emergency Telecommunications - Click on Standards
ETSI (European Telecommunication Standards Institute) develops standardization of Information and Communication Technologies.ETSI Wiki
Implantable Medical Device Standards
Global Digital Telecommunications Mobile StandardsR&TTE Radio and Telecommunications Terminal Equipment - Harmonized Standards
International Committee on Harmonization (ICH) Joint Initiative Council (JIC) SDO Global Health Informatics Standardization Council. JIC
ITU (International Telecommunications Union) ITU is a treaty organization of the United Nations. Standards work in the ITU is divided into two sections: ITU - Telecommunications (ITU-T) and ITU Radiocommunications (ITU-R) - ITU Wiki
IEC (International Electrotechnical Commission) IEC
ISO (International Organization for Standardization) www.iso.org
ASTM (ASTM International) ASTM www.astm.org
4G Mobile Telecommunications Standard