REGULATORY CONSENSUS ON INTERNATIONAL STANDARDS AND BEST PRACTICE WILL GIVE STAKEHOLDERS ASSURANCES ON THE SAFETY AND QUALITY OF HEALTHCARE.
Convergence between information and communication technologies (ICT) with medical devices plus the adoption of electronic health records (EHRs) is evolving rapidly. These factors are driving the development of new innovative ways of delivering healthcare. Connected Healthcare innovation requires work on multiple facets simultaneously while also addressing regulatory concerns. To ensure adequate risk mitigation the pace of adoption and deployment of Connected Healthcare innovation must be balanced by appropriate standards,regulations and accreditation programs.
Management of healthcare information referred to as health informatics is a key pillar of the envisaged benefits of Connected Health technology.Health informatics utilises the latest developments in medical device and ICT. Currently the International Standards Organisation (ISO) has published over 55 standards on health informatics and has about another 20 under development ranging from classifications and coding systems of surgical procedures to risk management for ICT networks incorporating medical devises. ISO collaborates with various organisations such as the Institute of Electrical and Electronics Engineering (IEEE), the International Electrotechnical Commission (IEC) and the InternationalTelecommunication Union (ITU). Continua HealthAlliance (Continua) an international organisation established in 2006 is focused on establishing interoperable systems for personal health solutions and has over 240 international companies as members.
The alliance awards certifications to provide assurance on products that have been proven to be interoperable in a rigorous testing environment. Integrating the Health Enterprise (IHE) formed in 2007 has over 370 member organisations. IHE promotes the use of established standards such as DICOM and HL7 to ensure relevant health information is conveniently accessible to patients and professionals. Continua and IHE both non-profit organisations recently agreed to support a single common IHE Device Enterprise Communication profile for feeding home device data and clinical device data into EHRs. The agreed interface architecture effectively allows almost any brand of personal health device and / or any brand of clinical device to be used in any appropriate setting providing near real-time updates of EHRs. Continua,IHE and ISO are non-governmental organisations and their standards are voluntary. Nonetheless,such initiatives will establish and ensure industry self regulation.The agreement between Continua & IHE exemplifies ICT and medical device convergence brought about by the US Federal Healthcare InformationTechnology Standards Panel (HITSP) EHR project. The HITSP was formed in 2005 for the purpose of harmonising standards in the healthcare industry to enable and advance interoperability of healthcare applications,accurate use,access,privacy and security of healthcare to support delivery of healthcare. Early in 2008,the FDA proposed the Medical Device Data System (MDDS) Rule reclassifying the regulatory status of certain software used with medical devices from Class III to Class I. The proposed MDDS Rule would change pre-market notification requirements for medical data systems used only by a healthcare professional. The software may acquire and transfer medical device data from medical devices for storage and retrieval,data display and conversion from one format to another based on a preset specification without altering the function or parameters of the connected devices.
The MDDS must not contain any diagnostic,decision support,alarm functions or utilize irreversible compression. If an MDDS device is indicated for lay use or performs irreversible data compression,the device would not be exempt from 510(k) requirements or pre-market notification prior to marketing the device. The rule is not yet a regulatory requirement,nonetheless in anticipation of the MDDS rule becoming law some Health InformationTechnology (HIT) vendors have voluntarily registered and listed their software devices with the FDA,while others have provided submissions for pre-market review. The proposed rule does not include software that merely performs library functions, such as storing, indexing and retrieving information. In April FDA announced the Home Use Initiative to ensure caregivers and patients safely use medical devices in the home. The goal is to develop guidance for manufacturers who intend to market medical devices for home use, provide for post-market surveillance and other measures to encourage safe use of these products. An increasing number and variety of medical devices that provide patient or individual monitoring,therapy, treatment and responsive intervention are being developed that operate using wireless communication. The FCC and FDA recently agreed an MOU to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices. There are also numerous organisations such as the UN Foundation mHealth Alliance established in early 2009 dedicated to enabling the delivery of quality health via wireless networks.
As the healthcare system becomes increasingly reliant on digital technology and EHRs, it is clear regulatory oversight must evolve in parallel with HIT to ensure quality and safety. Connected Health systems consist of multiple hardware and software components for which clarification on the scope of responsibility of individual manufactures is required. To help address the current uncertainty concerning the evolution of Connected Health regulation the mHealth Regulatory Coalition was established in the US in June. The goal is to develop, over the next year, a consensus among industry participants regarding the scope of FDA regulation for mobile health technologies and propose the consensus to FDA for adoption as a guidance document. A balance must be reached between the necessary regulatory oversight and initiatives to facilitate innovation in healthcare. Regulatory clarity combined with consensus on international standards and best practices will help give all stakeholders the necessary assurance on the safety and quality of innovative healthcare sufficient for future requirements.