Coinciding with the second day of congressional hearings on FDA regulation of mobile medical apps last week, McKesson announced the launch of a new app, Medisoft Mobile, for doctors and their staff that aims to make it easier to manage their practice through iPhones or iPads. Between the Medisoft Mobile app and the newest version of Medisoft software, care providers can now use their mobile devices to view schedules as well as to transmit charges, diagnosis codes and notes to the front desk.
One week later, McKesson's pharmacy systems and automation division announced a deal with mscripts to bring to market a mobile pharmacy offering that works with McKesson's EnterpriseRx pharmacy management system. The updated mobile practice management system enables pharmacies to talk to patients via two-way SMS text messaging and other mobile apps that run on iOS, Android, and Windows Phone operating systems. The system enables patients to refill prescriptions, receive pickup and dosage reminders, and more. It also enables pharmacies to send patients surveys or information about their clinics, drug recalls, or coupons.
During the second day of hearings last week, McKesson's Senior Vice President of Clinical Development and Strategy, Dr. Jaqueline Mitus, said in her opening remarks: "The current regulatory approach for medical devices, however, is not well-suited for health IT. For example, does an iPad that reminds a patient to refill a prescription make it a medical device? What about an application that allows a clinician to access a medical journal or review an x-ray online? Should these applications and the iPad each be subject to FDA regulation?"
On the third day of hearings last week, Rep. Henry Waxman (D-CA) asked the FDA's Christy Foreman whether the FDA would regulate a series of apps and devices, including: Mobile devices in general like the iPhone, iPad, BlackBerry, PDA, all health IT, an app to remind you to refill a prescription, and an app to help a doctor search a medical textbook. In all those cases Foreman said "no". The FDA has cleared a couple of apps that aim to help physicians make diagnostic decisions based on x-rays and other images displayed on a mobile medical app, but non-diagnostic imaging apps have been available for years.