Old style norms, codes and standards for telehealth (including telecare) have often been top-down and prescriptive. But the International Code is different because it embodies an approach that is strategic, flexible and user-oriented. This approach enables the services to operate more flexibly and in more imaginative ways. Assessments (and certifications) of telehealth services against the requirements of the Code are, therefore, more about judgements than they are about strict measures of performance.
What drives the International Code is a strong belief in ethical, open and responsible service provision. This impacts, of course, not just on the way that services are provided but on the design and configuration of the technologies harnessed.
The main consideration is the ways in which services can foster personal well-being as well as clinical health. This means that the ‘position’ of the International Code is, in large part, within the arena of public and preventative health and relates, therefore, to services provided both in more localised community settings and also in regional national or international contexts.
Our emphasis on ethical and responsible service provision justifies the requirements (as set out within the International Code) for services, in order to be certified, to be open about their policies and practices, as well as about the way they operate. Services must, for instance, post key documents and declarations on their websites or in the Discovery Zone of the TQG website. This enables them to demonstrate their ‘accessibility’ and, in part therefore, their accountability to users as well as to other stakeholders (including regulatory bodies).
A strong emphasis, it can be noted, is given to the way that personal data is held and secured – this representing a particular concern in our current context of global communications networks.
2) What kinds of services are covered by the International Code?
The International Code is relevant for a wide range of types of telehealth services. Many of these are set out in the Code’s Introduction. The range extends from vital-signs and activity monitoring (including video-consultations) to telecare, social (safety) alarms and PERS (personal emergency response systems). In some countries these kinds of services are gathered under the title ‘technology-enabled care services’ or TECs.
3)Can my service be certified against the requirements of the International Code? Can services self-assess?
Any operational telehealth service can become a Full Member of the TQG and, therefore, able to be assessed, self-assess and potentially certified against the requirements of the International Code. At the outset, however, services must make clear and re-affirm on an annual basis their intention to develop and/or maintain their service in accordance with Code requirements. Other services (or other stakeholders) can become an Associate Member of the TQG.
By becoming a Full Member, as well as being part of the growing telehealth community, services can participate at discounted rates in TQG training courses and events that include the Annual Medetel Conference in Luxembourg.
Full members that meet the requirements of the International Code (and have either been independently assessed or for which the outcomes of any self-assessment have been accepted by the TQG Certification Board) are able to display a different TQG logo on their literature, website, etc. If they are not yet certified in accordance with the requirements of the International Code but remain committed to achieving certification, they can retain their status as Full Members for a maximum of four years.
4)How much does it cost to be a Full Member?
The relevant annual membership fee levels for Associate and Full TQG members for 2015/16 can be found here.
5)How do services get certified?
As well as being able to obtain an independent assessment from an organisation approved by the TQG, Full Members are able to self-assess against the requirements of the International Code. The charges that relate to this are set out below (within these FAQs).
The TQG is developing a self-assessment tool to help services. It will be freely available in January 2016. Subject to satisfactory evidence being provided, together with necessary declarations being made, services that meet the requirements of the International Code on the basis of self-assessment are able to display a distinctive TQG logo on their literature, website, etc.
Those Full Members that both meet the requirements of the International Code and have been externally assessed are able to display a further and distinctive TQG logo on their literature, website, etc. (see below). The process for external assessment is available via the TQG, as agreed in collaboration with DNV GL.
Membership fees do not include the costs of independent assessment. Those assessment costs are directly payable to the approved body in question and are likely, initially (for a ‘Foundation Assessment’) to be in the order of e.g. €2000-2500 for a modestly sized telecare services with clear operational procedures. This sum increases for larger and more complex services.
DNV GL (www.dnvglhealthcare.com), an international body with significant expertise, is the first certification body to be approved by the TQG to undertake such assessments. Certification decisions are made by the TQG Certification Board based on the information provided by telehealth services and, wherever applicable, that of the approved bodies undertaking independent assessments.
6)Is advice available to help services become certified?
Both the TQG and DNV GL offer reviews and support visits that can help services in their progress towards certification. The cost of these, depending on the particular needs, is available on request. Services may also be assisted through participation in TQG and DNV GL seminars and training events.
7)How are services monitored?
The TQG, operating in collaboration with the approved bodies, monitors the documents and declarations made by services and periodically checks their credentials either directly (e.g. by examining the contents of websites) or indirectly (e.g. with relevant registration bodies).
Spot checks that include on-site visits can also take place to ensure compliance or assist in enquiries that relate to formal complaints made that are indicative of serious service shortcomings. The process of monitoring can lead to the issuing of ‘non-conformity’ notices and, where there are on-going and/or significant shortcomings, the certified status of a telehealth service being suspended or revoked. Decisions on such matters are made by the TQG Certification Board.
8)Can I use my existing accreditation (or certification) to help recognition of my service to the International Code?
The TQG is committed to collaborating with relevant bodies that offer codes, quality marks and standards. That collaboration seeks to bring about a framework wherein services will be both able to be certified against the requirements of the International Code and other more operational codes – including, for instance, those which apply to telecare, vital-signs monitoring and virtual visits. Hence, if, within the last year, your service has been accredited or certified by a qualified external body to any of the following codes and there has been no significant change in the nature of the service provided, this may facilitate a reduction in the cost of independent assessment to the International Code.
This potential cost reduction applies with the following codes, standards (norms) and quality marks – these each being recognised by the TQG as relating to some aspects of the International Code. The codes, standards and quality marks emanate from well recognised bodies such as Wonen, Diensten en Techniek voor Mensen (WDTM) in the Netherlands; the American Telemedicine Association (ATA); and the Community Equipment Services CIC (CECOPS) and Telecare Services Association (TSA) in the UK.
- eHealth: Telehealth Standards (2012, Australia)
- Code of Practice – personal Emergency Response Services (2009, Australia)
- Telehealth Services – Standards (2014, Canada)
- Alarm Systems – Social Alarm Systems EN50134-7 (2003 and 2015/16 forthcoming, EU)
- Qualité de Service en Téléassistance NF X50-520 (2013, France)
- Staying at Home: Requirements for Suppliers of Combined Services VDE AR E 2757-2 (2011, Germany)
- Supply Chain Quality Mark for Personal Alarm Services (2012, Netherlands)
- Code of Prcatice – Telecare Services (2011, New Zealand)
- Servicios para la Promoción de la Autonomía Personal – Gestión del Servicio Asistencia UNE 158401 (2007, Spain)
- Code of Practice for Disability Equipment, Wheelchair and Seating Services (2015, UK)
- Integrated Telecare and Telehealth Code of Practice (2013, UK)
- Online Patient Consultations (2015, United States)
- Core Operational Guidelines for Telehealth Services involving Provider-Patient Interactions (2014, United States)
It needs to be noted that the following standard emanating from the International Organization for Standardization (ISO) is fully incorporated within the International Code. This means that certification against the requirements of the International Code also carries with it confirmation of service compliance with the requirements of this ISO standard.
- Quality Planning Guidelines for Telehealth Services ISO/TS 13131 (2014, International)
9)Can I use a TQG logo once my service has been certified to the International Code?
Yes, there is a special logo that you can use that attests to your self-certification (read further for certification via independent assessment). This is, however, subject to approval by the TQG Certification Board. Usage of the logo is permitted on the service website, letter heads and business cards; and in publicity and promotional material. This privilege is conditional on services being clear in such material (and in their business dealings) that no independent assessment by an approved organisation has taken place.
The logo that is available for self-certified services is made available at the following charges.
|Full Memer (Level 1)||€1000 (Year 1) [£735] then yearly at 60% subject to annual self-certification, viz. €600 [£440]|
|Full Member (Level 2)|
|Full Member (Large)||Minimum €2000 (Year 1 – equal to annual membership fee) [min £1470] then yearly at 60% subject to annual self-certification, viz. Minimum €1200 [min £880]|
For those services that are certified following independent assessment by an approved organisation a further ‘extra’ special logo can be used. Given their current status as the sole approved assessment body, this logo links the motifs of both the TQG and DNV GL. The cost of this ‘extra’ special logo is incorporated in charges levied for assessment – i.e. there is no additional charge.