WMA Statement on Mobile Health


Adopted by the 66th WMA General Assembly, Moscow, Russia, October 2015

PREAMBLE

Mobile health (mHealth) is a form of electronic health (eHealth) for which there is no fixed definition. It has been described as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other devices intended to be used in connection with mobile devices. It includes voice and short messaging services (SMS), applications (apps), and the use of the global positioning system (GPS). 

Sufficient policies and safeguards to regulate and secure the collection, storage, protection and processing of data of mHealth users, especially health data, must be implemented. Users of mHealth services must be informed about how their personal data is collected, stored, protected and processed and their consent must be obtained prior to any disclosure of data to third parties, e.g. researchers, governments or insurance companies.

The monitoring and evaluation of mHealth should be implemented carefully to avoid inequity of access to these technologies. Where appropriate, social or healthcare services should facilitate access to mHealth technologies as part of basic benefit packages, while taking all the required precautions to guarantee data security and privacy. Access to mHealth technologies should not be denied to anyone on the basis of financial status or a lack of technical expertise.

mHealth technologies cover a wide spectrum of functions. They may be used for: 

  • Health promotional (lifestyle) purposes, such as apps into which users input their calorie intake or motion sensors which track exercise.
  • Services which require the medical expertise of physicians, such as SMS services providing advice to pregnant women or wearable sensors to monitor chronic conditions such as diabetes. mHealth technologies of this nature frequently meet the definition of a medical device and should be subject to risk-based oversight and regulation with all its implications.

mHealth may also be used to expedite the transfer of information between health professionals, e.g. providing physicians with free, cross network mobile phone access in resource poor settings.

Technological developments and the increasing prevalence and affordability of mobile devices have led to an exponential increase in the number and variety of mHealth services in use in both developed and developing countries. At the same time, this relatively new and rapidly evolving sector remains largely unregulated, a fact which could have potential patient safety implications.
 
mHealth has the potential to supplement and further develop existing healthcare services by leveraging the increasing prevalence of mobile devices to facilitate access to healthcare, improve patient self-management, enable electronic interactions between patients and their physicians and potentially reduce healthcare costs. There are significant regional and demographic variations in the potential use and benefits of mHealth. The use of certain mHealth services may be more appropriate in some settings than others.
 
mHealth technologies generally involve the measurement or manual input of medical, physiological, lifestyle, activity and environmental data in order to fulfil their primary purpose. The large amount of data generated in this way also offers huge scope for research into effective healthcare delivery and disease prevention. However, this secondary use of personal data also has great potential for misuse and abuse, of which many users of mHealth services are unaware.
 
The expansion of mHealth services has been largely market driven and many technologies have been developed in an uncoordinated, experimental fashion and without appropriate consideration of data protection and security or patient safety aspects. It is often impossible for users to know whether the information provided via mHealth stems from a reliable medical source. Major challenges faced by the mHealth market are the quality of mHealth technologies and whether their use ultimately helps patients or physicians achieve the intended purpose.
 
Comprehensive regulation and evaluation of the effectiveness, quality and cost effectiveness of mHealth technologies and services is currently lacking, which has implications for patient safety. These factors are crucial to the integration of mHealth services into regular healthcare provision.

RECOMMENDATIONS

The WMA recognises the potential of mHealth to supplement traditional ways of managing health and delivering healthcare. While mHealth may offer advantages to patients otherwise unable to access services from physicians, it is not universally appropriate, nor is it always an ideal form of diagnosis and treatment option. Where face-to-face treatment is available this is almost always advantageous to the patient.
 
The driving force behind mHealth must be the need to eliminate deficiencies in the provision of care or to improve the quality of care.
 
The WMA urges patients and physicians to be extremely discerning in their use of mHealth and to be mindful of potential risks and implications.
 
A clear distinction must be made between mHealth technologies used for lifestyle purposes and those which require the medical expertise of physicians and meet the definition of medical devices. The latter must be appropriately regulated and users must be able to verify the source of information provided. The information provided must be clear, reliable and non-technical, and therefore comprehensible to lay people.
 
Concerted work must go into improving the interoperability, reliability, functionality and safety of mHealth technologies, e.g. through the development of standards and certification schemes.
 
Comprehensive and independent evaluations must be carried out by competent authorities with appropriate medical expertise on a regular basis in order to assess the functionality, limitations, data integrity, security and privacy of mHealth technologies. This information must be made publicly available.
 
mHealth can only make a positive contribution towards improvements in care if services are based on sound medical rationale. As evidence of clinical usefulness is developed, findings should be published in peer reviewed journals and be reproducible.
 
Suitable reimbursement models must be set up in consultation with national medical associations and healthcare providers to ensure that physicians receive appropriate reimbursement for their involvement in mHealth activities
    
A clear legal framework must be drawn up to address the question of identifying potential liability arising from the use of mHealth technologies.
 
Physicians who use mHealth technologies to deliver healthcare services should heed the ethical guidelines set out in the WMA Statement on Guiding Principles for the Use of Telehealth for the Provision of Health Care.
 
It is important to take into account the risks of excessive or inappropriate use of mHealth technologies and the potential psychological impact this can have on patients.