Localizing mHealth Apps: Do special regulatory terms and conditions apply?

Commit_mHealthApps

by Nikoletta Kaponi, Project Manager at Commit

The rapid technological advances and the ever expanding use of mobile devices, from smartphones and tablets to wearables and wireless sensors, have not left the healthcare sector unaffected.

Mobile health (mHealth), which is defined as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices” by the EU Green Paper on mobile health, is expected to reach the equivalent of US$26 billion at a global level by 2017. With over 100,000 mHealth software apps currently available on the market, and their constantly growing popularity in developed and developing countries around the globe, mobile technology is changing the rules in the way healthcare professionals and patients interact.

The range of mHealth apps is broad and under constant expansion, including useful and valuable tools for both the individuals/patients and the medical staff: apps for vital sign measurement (e.g. blood pressure, heart rate, temperature etc.), blood glucose monitoring and diabetes management, photo-based skin lesion tracking or diagnosis, sensor-based medication compliance monitoring, diary-based pain management. These are just a few examples of how mobile device technology is contributing to the enhancement of healthcare services, allowing for a more evidence-based and patient-centric approach to healthcare, both of which have become more possible than ever via the use of mobile health apps.

While the possibilities for innovative healthcare apps and better healthcare services are ample, an important question arises regarding the reliability and safety of such apps in relation to their users. In answer to this question, the regulatory frameworks that apply to medical devices come to the foreground, setting down requirements and guidelines for the medical app developers and manufacturers to take into account and comply with.

In the US, the FDA has issued a guidance document for mobile medical applications, which are therein defined as “software applications that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server” and which meet the definition of a “medical device” and are to be used:

– “as an accessory to a regulated medical device”, or

– “to transform a mobile platform into a regulated medical device”.

Within the frame of this guidance, if the intended use of an mHealth app, as stated in the relevant labeling materials, “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”, then such an app is to be considered, and regulated, as a medical device.

While not all mHealth apps are medical devices, even for those that are, the FDA presents the option of “enforcement discretion” towards apps that pose a lower risk to their users, and intends to regulate more strictly those apps that could pose a higher risk to their users if they were “to not function as intended”. As part of this regulatory framework, the same classification requirements apply (Class I, Class II, and Class III), as with the “traditional” medical devices, in order to ensure users’ safety and their function as per the manufacturers’/developers’ intentions.

On the other side of the ocean, EU has laid out three directives for medical devices: one on Active Implantable Medical Devices (AIMDD), one on Medical Devices (MDD) and one on In Vitro Diagnostic Medical Devices (IVDMD). These directives are currently all in the process of being revised and are soon to be replaced by two regulations, one for medical devices and another for in vitro diagnostic (IVD) medical devices, following a proposal adopted by the European Commission in September 2012. According to this proposal:

“medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease,

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,

– investigation, replacement or modification of the anatomy or of a physiological process or state,

– control or support of conception,

– disinfection or sterilisation of any of the above-mentioned products, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”

The European Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices (MEDDEV 2.1/6) set out the criteria for “stand alone software” (i.e. software that is not integrated within a medical device) which qualifies as a medical device, therein referred to by means of the term “Software as a Medical Device (SaMD)” and further defined as a “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device”. Apps that fall under the SaMD definition are required to receive a CE mark, same as with other medical devices, and are also subject to the EU medical device classification (Class I, Class IIa, Class IIb, and Class III), for safety and appropriate development and use to be ensured.

Apart from the need for certain mHealth apps to be regulated as medical devices, the manufacturers of such apps also face the need to make their products accessible to as many people as possible worldwide. With over 2.6 billion smartphone users across the globe, 87% of whom always carry their smartphone with them, the potential of introducing a new product in as many markets as possible is very alluring, but also challenging, given the language and culture diversity of the receiving markets.

Surveys have shown that people primarily prefer to download mobile apps in their own native tongue, i.e. the version localized for their own locale, and this preference should perhaps be re-iterated as a need of paramount importance in the case of mHealth apps, given the nature of their functions and the sensitivity of the data processed. But, apart from user-defined needs, specific localization requirements are also prescribed by the regulatory standards of each country, which determine what must be localized in the country’s official language(s) and what may not. Therefore, the localization step becomes a highly important part of mHealth app launches worldwide, in order to ensure not only an improved end-user experience, but also compliance as far as “apps regulated as medical devices” are concerned.

mHealth app localization specifics include the typical elements of medical translation, which focus upon accuracy, terminology consistency, subject matter expertise and optimal quality assurance processes, and also some more technical tasks. Such tasks are the functional testing of the localized app within the mobile operating system(s) (e.g. iOS, Android, etc.) for which it is designed, followed by the fixing of any identified bugs, and the linguistic review of the localized app, i.e. the review of the translated content within-context in order to ensure the correctness of the translations used and to check for any character corruptions or overflowing/truncated text or misplaced content. These tasks allow for a hands-on validation of the localized apps and aim at eliminating functional and linguistic issues which could reduce the usability of the apps, as well as the clarity and precision of their content.

As mHealth apps are changing the standards of healthcare services and open up new possibilities for patients and doctors alike through a constant evolution of innovative technologies and brilliant ideas, the regulatory standards and localization processes are called to take a step further and grow in tandem, putting the spotlight on the safety and accessibility of mHealth app users.

What is Machine Translation and how can your business benefit from it

googletranslate

by Eftychia Tsilikidou, Project Coordinator at Commit

A question we are often asked as Language Service Providers is whether we use Google Translate in our work. This comes as no surprise as Google Translate is the most popular and well-known Machine Translation engine and many users turn to it when they need to understand a text in a language they do not speak. However, using this automated translation engine, one can quickly understand that the quality of the output can vary. Sometimes it will seem to work fine, giving results that resemble a human translation and other times the output is not at all satisfactory. But why is this happening? How does Google Translate actually work?

First, let’s have a look on how Google Translate defines itself:

Google Translate is a free translation service that provides instant translations between dozens of different languages. It can translate words, sentences and web pages between any combination of our supported languages.

When Google Translate generates a translation, it looks for patterns in hundreds of millions of documents to help decide on the best translation for you.

In order to explain the above statement more clearly, think of any Machine Translation engine as a massive “pool” that keeps inside thousands of millions of documents in all sorts of language combinations. Parallel texts, translated by humans, are gathered from different online sources and stored into this “pool”. Whenever users enter text that needs to be translated into a language they do not understand, the machine, through various processes, searches for matching patterns from the texts it contains in the pool and brings up the most relevant results based on certain statistical models. The process of creating this pool of training data is called “machine translation education” and there are various technologies in place for this purpose, with Statistical Machine Translation Technology being the most common.

Now, when it comes to high-level professional translation, Machine Translation should be examined as a very useful tool. Translation is a very complex activity that involves analyzing, interpreting and synthesizing elements of text and transferring them via the same process into another language – an ability, computers definitely do not possess, at least for the time being, no matter how many complex models they process. This is the reason why translation agencies rely largely on human translators. On the other hand, the human brain has certain weaknesses as well, as it is unable to obey to many strict linguistic rules.

Given that there is no MT in place that could imitate the function of a human brain and its ability to analyze and synthesize data, and that even human work needs corrections and entails certain weaknesses, a combination of both human input and automated translation systems could lead to some very good results.

Contrary to the very general and vast content used in Google Translate, when Translation Companies choose to build Machine Translation Systems, they can customize them based on domain, language combination and even customer specific needs. The more specific the content entered into these MT systems, the better the results.

But how can Machine Translation help YOUR business?

Our digital and global era has tremendously increased the amount of ready-to-publish content that needs to be translated into various languages as soon as possible. There is a constant demand and pressure to reduce prices, to introduce new services more quickly and effectively, to maintain the highest levels of customer satisfaction at the optimal turnaround time, cost and quality.

Machine Translation systems can help companies facing those challenges, if they are implemented wisely and offered as a complete solution rather than just as a mere translation process. Taking into account that the MT systems can be customized to meet specific customer needs, and combined with Translation Memories and human input, the time for the translation of large volumes can be significantly reduced, leading, consequently, to reduced costs. Projects that would normally require months to be completed following the traditional human translation path, can now be completed within weeks or less with the implementation of an MT system.

Another circumstance to consider an MT system as a translation solution is when you are faced with a large volume of content and need to get a rough idea in order to decide which content to translate.

However, Machine Translation Systems cannot be used for all kind of texts and in every situation.

Content that involves translations of technical documentation, manuals, software interface, help content as well as automotive, mechanical, medical and legal documents are just some examples of texts with repetitive patterns, specific styles and certain rules, which can effectively train an MT system and subsequently be used for the translation of new content.

The main purpose of technology is to ease people’s life and raise its quality. Machine Translation cannot replace human translators, since language is live and constantly evolving. However, it can certainly aid the entire translation process and, if used wisely, can provide significant benefits for both translators and their customers.