Archive for July 29, 2011

FDA takes first step toward regulating medical-related apps

Walk into a hospital or clinic these days and it’s increasingly likely you will find the doctor carrying a mobile tablet or smartphone. Use of these handheld digital devices has proliferated as medical professionals and the world at large find much to like in their mobility, ease of use, and growing app offerings.

So popular are these devices, the U.S. Food and Drug Administration (FDA) estimates that by 2015 the number of smartphone users across the world will reach some 500 million. Not surprisingly perhaps, the FDA is now looking to regulate any apps intended for health- or medical-related purposes.

According to a recent post on the Foreign Exchange Translations blog, the FDA recently took the first step by releasing draft guidelines for regulation. It has separated mobile apps into four categories, each with a distinct regulatory strategy. These include:

• Apps that display, store, or transmit patient-specific medical device data in an original format
• Apps that control the intended use, function, modes, or energy source of a connected medical device
• Apps that turn the mobile platform into a regulated medical device (e.g., electronic stethoscope apps that use the phone’s microphone)
• Apps that create alarms, recommendations, or new information by analyzing or interpreting medical device data

The FDA is inviting the public to comment on its app regulation proposals. And that public, especially the app developer community, may indeed have a good deal to say.

Till next time,

Clinical trials turn to outsourcing, bringing new medical translation needs

As with so many industries in today’s globalized world, clinical research is increasingly electing to outsource its work to other countries, including China, India, Russia, and Brazil. By 2012, it expected that some 65 percent of FDA-regulated clinical trials conducted by major pharmaceutical companies will be outsourced.

What is driving the trend? Advantages include the following:
• Reduced operational costs
• Simplified recruitment
• Better access to large pools of qualified patients
• Positive patient attitudes toward clinical trials
• The growth in the spectrum of diseases in emerging countries that are also present in developed countries

As a result, non-U.S.-originated regulatory submissions account for an ever greater percentage of regulatory submissions. And related agencies are being forced to adapt. The FDA, for example, has set up formal offices in China and India to oversee this developing facet of clinical trial operations.

The challenges in the face of such a significant change in clinical research practice are many and significant. Regulatory differences, for example, remain a major hurdle as does ensuring that international ethical standards are followed.

Language and linguistic demands also figure at or near the top of the list. As with medical translation elsewhere in the industry, language, cultural, and socioeconomic factors must be considered. Insufficient attention to these critical details can severely undermine outsourcing efforts.

For this reason, the authors of a recent paper on the subject entitled “Language and Culture in Global Clinical Trials” recommend that those conducting trials establish a local presence; work with reputable partners; and seek out experienced language service providers.

Till next time,

Medical translation figuring in emerging healthcare apps

Every software developer is looking for the “killer” app. With the growing popularity of smartphones and tablets like the iPad, the market for such applications is skyrocketing. Not surprisingly, healthcare is a common focus of these burgeoning tools, and the U.S. government, among others, wants to help spur that innovation.

Just ask Polyglot Systems. The North Carolina-based company (and viaLanguage client!) was just awarded the $5,000 top prize in a federally funded program that invited app developers to compete with each to develop the best health IT apps.

The winning app, chosen from a field of 15 contenders by a panel of health IT industry leaders, provides simplified medication instructions in multiple languages. Called “Meducation,” it retrieves medication lists from electronic health records (EHRs), and then links to a drug information database that provides simplified medication directions in one of several languages.

The contest grew out of a $15 million grant provided by the Office of the National Coordinator for Health IT through its Strategic Health IT Advanced Research Projects program. Meanwhile, researchers at Children’s Hospital Boston and Harvard Medical School developed Substitutable Medical Applications, Reusable Technologies (SMART), a programming interface to support the development of health-related apps.

It is encouraging to see both the resources and energy devoted to applying technological innovation to improving healthcare. It is doubly encouraging to see that translation needs are figuring in those efforts.

For more on the contest, check out the recent post on the iHealthBeat blog. And congratulations to Polyglot from all of us here at viaLanguage!

Till next time,