Here are some snippets from a recent blog post on research2guidance titled, "What does it take to develop a successful mHealth app – insights into a pharmaceutical company."
[This guest post was written by Alexander Romantschuk, Innovations Leader, Lilly Germany, Alexander studied molecular and surface physics at the University of Bielefeld, Germany. Since November 2005 he has held the position of European Medical Innovations Leader at Eli Lilly. Here he was responsible for numerous prototypes for internal medical clients. Since mid-2009 his team has been working on mobile devices and mobile applications. He is sharing his experience of the development of mHealth apps in a regulated health care environment. ]
Mobile app development – a field report from a pharmaceutical company
The pharmaceutical industry is highly regulated. The main reason for these regulations is to protect the consumer; patients who need to take drugs. Buzzwords like GxP, CRF Part 11, Data Privacy, Compliance, Regulatory and IT Validation are used regularly if an IT application is developed. From an IT process point of view there is no reason to distinguish between the developments of a normal web application or an application for a mobile device but in reality people’s minds make a big difference. Smartphones, mobile broadband and availability are still ‘new’ and especially for the conservative pharmaceutical industry it isn’t that easy to adopt these new concepts.
Legal, compliance and regulatory approvals
What about legal, compliance and regulatory approvals? As mentioned above the pharmaceutical industry is highly regulated. To answer questions around promotional material, copyright, contracts, disclaimer, data privacy, compliance to laws and regulations you need to get in contact with your legal and compliance department to gain approvals. In the end we have all the necessary approvals to go ahead. An important point for an international company is the understanding of different laws and regulations in different countries. If you desire to replicate an existing regulated app from Germany to Spain for instance, you need to contact your local Compliance, Legal and Regulatory department to answer the same question again based on local laws. That is a cumbersome and time consuming process.
Is the mobile phone a medical device?
One very interesting question we answered as part of the whole approval process I would like to consider more in detail. Imagine you develop an application which is supporting some kind of diagnosis for a patient. Based on the result and additional information the physician determines the therapy for a patient. Does this software change the status of the device you install it on? Is the iPhone (or any other smartphone) a medical device in the case that you install our app on it? We discussed this question extensively with the help of an external lawyer, our medical department, compliance, legal and regulatory department and again the answer of no it isn’t a medical device was provided. In case the answer would have been yes, we would have needed to add an additional certification, the so called and well known CE certificate.
Read the entire blog post on research2guidance.