While the medical industry is increasingly buzzing with concepts such as telemedicne, telehealth, telecare, m-health, we are yet to see how long they take to become a standard way of care. Perhaps the more important question is: how long will telemedicine benefit from low barriers to entry and a positive innovative environment before the regulatory bodies limit the sort of freedom its providers currently enjoy?
A Closer Look at Mobile Health
Looking more closely at the mobile health industry — and healthcare apps flooding the market — it’s clear that the regulatory framework is starting to take a shape, as evident in guidance documents published in the US (Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications) and more recently in the EU (Guidelines on the Qualification and Classification of Stand-Alone Software used in Healthcare within the Regulatory Framework of Medical Devices). The documents have been criticized as having omitted the differentiation between low risk healthcare apps — such as fitness or running apps — and the higher risk apps, for example involving diabetic platforms.
Indeed, the so called “m-health” industry is a grey area characterized by fast moving technology platforms, which makes it harder for regulators to decide on a final regulation to standardize the approval, market access and reimbursement of those apps or other healthcare software.
Pitfalls of Regulation
Regulating the telemedicine market, including m-health, has the potential to stifle innovation and threaten small businesses and new entrepreneurs that feed the market. On the other hand, the public bodies’ endorsement (like the NHS in the UK) is needed to ensure public confidence in mobile health, and secure early adoption of the technologies. The balance lies somewhere in between, and the sector, I would say, is still at its infancy weighing its options between the two.
The Key Issues
- Technology Platform
Another pertinent issue is the technological platform. If we were to envision a future where CT scanners and MRI devices send patients’ digital images straight to doctors’ smartphones via mobile networks and WiFi, there needs to be a network system that supports this — currently there isn’t.
- Data Volume and Speed
The amount of data that needs to be transferred in the future will be huge and software developers need to make sure that the network infrastructure is aligned with their needs. Another issue is the urgency of the data to be transferred. CT scan results can take few hours or days before being pushed to the doctors’ mobiles, however, if we think of a diabetic platform similar to the recently launched Cellnovo, when a patient is hypoglycaemic, the cellular bandwidth at which the device sends signals to the mobile phone needs to be somehow prioritized. Moreover, when similar devices come into the market, cellular urgency becomes an issue.
- Data Security
The last concern is data security that affects telemedicine as a whole, specifically stressed upon in e-health and electronic records. As the public sector considers adopting m-health, the assurance of data secrecy and protection concerns will need to be answered.
In an era of chronic disease and crunched budgets, mobile health and telehealth has the potential to lead the way in improving quality of care and remote access to personalized treatment and care, however not without challenges and some bumpy rides.