On 23 September 2013, the United States’ Food and Drug Administration (FDA) issued final guidance on its regulatory approach to mobile medical applications (apps). This guidance evidences the beginning of a mobile health technology revolution on both a local and international scale. This new approach also raises questions about whether Australia’s relevant agencies need also to consider any regulatory regime to ensure accuracy and reliability of mobile medical apps.
United States Approach to Regulation
The guidance provides a roadmap to easily determine what apps are likely to be regulated by the FDA. A mobile medical app will be regulated where it falls under the definition of “device” under the Federal Food, Drug, and Cosmetic Act (FDCA).
A “device” is defined as an instrument, apparatus, implement or similar article that is:
- recognised in the National Formulary or United States Pharmacopoeia;
- intended for use in the diagnosis of disease or other conditions; or
- intended to affect the structure of function of the body of man or other animals and does not achieve its primary purpose through chemical action.1
The FDA’s regulatory authority will only apply to mobile apps that fall under this definition of ‘device’ and whose performance could pose a risk to public health in the event of a malfunction. For example, where an app is used for diagnostic purposes and is relied upon by laypeople with little to no medical knowledge.
It is important, now more than ever, that Australia take guidance from the United States experience and assess the need to attempt to address the complex regulatory challenges in relation to mobile medical applications.
In Australia, the Therapeutic Goods Administration (TGA) oversees regulatory processes and all medical devices are required to be included in the Australian Register of Therapeutic Goods (ARTG).
For regulatory purposes, Smartphone apps are either categorised as “health apps” or “medical apps”. Health apps are non-invasive and relate to general health and wellbeing whereas medical apps provide diagnostic tools and can make treatment claims. A medical or health app will be subject to regulation by the TGA if it falls under the definition of a “medical device” under section 41BD of the Therapeutic Goods Act 1989 (Cth).
Section 41BD defines a “medical device” as any instrument, apparatus, application or other article that:
- can be used on human beings;
- has therapeutic benefits (e.g. diagnosis, prevention, monitoring, treatment); and
- doesn’t achieve its principal intended action on the human body through chemical or metabolic means.
Mobile apps that are simply sources of information such as calorie counters or dosage calculators will not fall within this definition.
In Australia, as similar to the United States, the TGA applies a risk-based approach to regulating medical devices requiring:
- classification of the device under the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations);
- conformity with the Essential Principles in the Regulations; and
- conformity Assessment Certification, ensuring all requirements are met.
In December 2012, the Commonwealth Consumer Affairs Advisory Council (CCAAC) released an Issues paper on ‘App purchases by Australian consumers on mobile and handheld devices’. A submission made to CCAAC by the Medical Technology Association of Australia, suggested that medical apps “that are intended by the developer to cure, treat, monitor or diagnose a medical condition” should be regulated.2
In CCAAC’s final report, released in July 2013, the Council labeled mobile app regulatory matters as sufficiently complex and refused to make “any assessment of the need for additional regulation on health and safety grounds”.3 However, the report acknowledged that “regulatory options could play a role in improving outcomes for the community”.4 This report clearly demonstrates the need for Australia to develop a more comprehensive policy to better address regulatory concerns.
Looking to the Future
The TGA is a founding member of the International Medical Device Regulators Forum (IMDRF), which is working towards developing a uniform approach to the regulation of medical device software. In 2013, the IMDRF established a working group with the aim of developing and harmonising regulatory approaches on an international scale.
It is hoped that the TGA will begin drafting more detailed policy on medical device software, including mobile medical apps, when the Forum releases its final recommendations. With the use and development of mobile technology on the rise, it is imperative that Australia seeks to develop a more considered approach to regulating the use of medical apps in health care.