Step 3. Review legal aspects of mHealth
It is essential that all staff members are aware of the legal implications around the use of mobile technology in the practice. It is required by law that any identifiable patient information is kept secure and your practice is legally obliged to ensure that patient’s privacy and confidentiality is protected. Refer to Chapter 3. Collection of solicited personal information of the Australian Privacy Principles.
All mobile devices are at risk of being lost, stolen or left unsecure, which increases the risk of unauthorised access to data. Practice computer and information security measures may need to be broadened to include all mobile devices. This can be achieved by having a practice policy that addresses:
- password protection for all mobile devices
- encrypted transfer of data from all mobile devices
- anti-virus software for all mobile devices.
It is also important to be aware of the fact there may be other devices that need to be considered as part of an mHealth strategy. For example, you may implement policies related to accessing work data from home computers and from shared computers, such as at internet cafes and third-party mobile devices.
Refer to the RACGP’s Computer and information security standards (CISS) and Handbook for the management of health information in general practice for more information.
Mobile apps: are they regulated
The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purposes. This includes medical devices, from bandages to complex technologies like heart pacemakers.
According to the TGA definition, a medical device is any instrument that has a physical or mechanical effect on the body or is used to measure or monitor functions of the body. As a result, the TGA only regulates software that can diagnose, prevent, monitor, treat or alleviate a disease, injury or condition.1
Software that would satisfy the definition of a medical device includes, for example, smartphone apps that measure blood glucose levels and patient body temperature, x-ray image- processing software and diagnostic software. Medical records management systems or a dosage calculator would not come under this definition unless they also incorporate a therapeutic or diagnostic function.
Visit www.tga.gov.au/regulation- medical-software-and-mobile-medical- apps for more information.
Apps that bring patient and clinical information together
Patients know best (PKB) – a patient-owned healthcare record system in the United Kingdom (UK) that stores information behind the secure National Health Service (NHS) network. Patients monitor their own vital signs and link
to a PKB app or website via more than 100 wearables and other devices. Each patient’s record is uniquely encrypted and information is uploaded and shared with doctors and researchers if the patient agrees. Only the people to whom the patient gives consent can decrypt and access the record. PKB integrates fully into any health records system, including the NHS secure network, and is available for use by patients and clinicians worldwide.
for more information.
Health fabric – an online, tablet- based solution that enables patients to control their own health and social care record. This record integrates this with patients’ general practice systems so personalised and integrated care planning can be executed, with the patient ‘owning’ their own information accessed via tablet, mobile or web.
This helps multi-disciplinary teams achieve patients’ personal outcome goals and allows more patients to live independently, increasing real-time access to clinical information at the point of care.
Visit www.healthfabric.co.uk/index.html for more information
Empowering people with type 2 diabetes using digital tools
Diabetes is a major health problem in Australia that places a significant burden on the broader healthcare system. Diabetes is Australia’s sixth leading cause of death, an estimated 1.7 million people living with the disease and 500,000 unaware of their condition. The total annual cost impact of diabetes in Australia is $14.6 billion.2
The mHealth pilot program, ‘Mobile health: Empowering people with type 2 diabetes using digital tools’, was designed in recognition of the fact that lifestyle modification is a continuing effort, beyond just the consultation with medical professionals. Pilot participants were provided with mobile tablet devices (iPads) with appropriate health apps in order to evaluate a program of self-management of diabetes.
The findings of the pilot reveal that equipping patients with diabetes with digital skills generates health benefits. Many participants experienced improvement in their conditions and the majority felt that the iPad helped manage their health. The digital feedback loop provided by the mHealth apps empowered participants to develop a sense of responsibility for their own healthcare. The study also highlighted that age is not a significant barrier, with 82% of participants 50 years and older.
Executive project summary
Full project report