Digital Pharma: Mobile app regulation
pharmafile | July 21, 2011 | News story | Medical Communications, Sales and Marketing | Digital Phama blog, app, ipad, iphone, mobile
The FDA has proposed new rules for smartphone apps, but says the guidelines will only apply to a small number of medical apps.
Mobile apps are an area of burgeoning interest for the pharmaceutical industry, which has been particularly keen on patient diary apps and calculators for healthcare professionals – some of which may fall within the FDA’s new guidance.
The US regulator has just launched a three-month consultation on its plans to oversee what it terms “mobile medical apps”, those that could cause patients harm if they don’t work as intended.
“As is the case with traditional medical devices, mobile medical apps can pose potential risks to public health. Moreover, mobile medical apps may pose additional or different risks due to the unique characteristics of the platform,” the FDA said.
The FDA has already cleared a handful of mobile medical apps used by health care professionals.
FDA policy advisor Bakul Patel said: “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks.”
The first FDA-cleared smartphone app to reach the iPhone App Store was the Airstrip OB, which debuted in 2009 and allows obstetricians to remotely monitor mother and baby during delivery.
In February this year the regulator approved another smartphone app. The Mobile MIM iPhone and iPad app integrates with a secure web-based medical imaging service, MIM Cloud, allowing doctors to view CT scans and MRI images before they return to their workstation.
The same month saw the FDA approve MobiUS, an ultrasound system that is integrated into a Windows Mobile smartphone.
But, although a combined iPhone case and app that could perform ECG readings was unveiled with much fanfare in February this year, the FDA has yet to approve the device, and there may lay the rub for pharma if its hitherto easy-to-launch apps become tied-up in red tape.
Types of apps the FDA’s guidance could cover include:
• Apps that perform calculations intended to be used by clinicians for automating tasks
• Apps that connect to a home use diagnostic medical device such as a blood pressure metre, body composition analyser, or blood glucose meter to collect historical data or to receive, transmit, store, analyse and display measurements from connected devices
• Apps that act as calculators or utilise algorithms to produce an index, score, scale, or other similar calculation
• Apps that act as calculators to determine the maximum dosage of local anesthaesia based on a patient’s weight and age
• Apps that collect blood glucose readings and caloric intake to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments
• Apps that act as a dosing calculators for a treatment regimen intended for a specific patient population (e.g. paediatrics)
• Apps that define disease stage or progression, and provide a prognosis of a medical condition or predict a patient’s response to treatment based on a analysis of physiological, laboratory and other data
The FDA guidance will not cover the following types of mobile apps:
• Electronic versions of medical textbooks, teaching aids or reference materials
• Mobile apps used solely to log, record, track, evaluate or make decisions or suggestions related to developing or maintaining general health and wellness
• Generic aids that assist users but are not commercially marketed for a specific medical indication (e.g. a magnifying glass app not specifically meant for medical purposes)
• Mobile apps that perform the functionality of an electronic health record system or personal health record system.
The FDA said it would monitor the performance of apps that fall outside of its guidance and then determine whether any additional measures are necessary to protect public health.
• View/Download: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications
• Browse a comprehensive list of pharma mobile apps
Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog He can be contacted via email, Twitter, LinkedIn or Google+.
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