ghp September 2015 | 31 regulation and policy Health Tech Apps Are Muddying the Already Unclear Regulation Waters From cardiac devices to knee implants, millions of consumers across Europe rely on medical equipment to improve their health and overall quality of life. The sector is now growing more complex as it moves to embrace health apps: software programmes that have been developed to provide a wide range of services from monitoring life threatening conditions to reminding users to take critical medications. With this growing complexity, it becomes more important than ever for manufacturers to be prepared and maintain regulatory compliance. In August 2015 alone there were eight separate medical device alerts registered by the Medicines and Healthcare products Regulatory Agency (MHRA), ranging from syringes and insulin pumps through to home-use blood glucose monitoring systems and sur- gical hair clippers. The previous month this figure was even higher. As we’ve seen in recent recall events, there are a variety of reasons that can cause a recall to occur and manufacturers should be keenly aware that recalling a product could be necessary at any time. Looking at recalls in general, fault device connection is often the leading cause. As technology continues to advance it is likely that connection and software errors will continue to increase which will have a significant impact on the notification and recall landscape. To add to this, as we highlight in the Stericycle Recall Index for Q2 2015, the medical apps market is also challenged by product classification issues, so it has become incumbent on developers of these products to inform themselves about the regulations that they must comply with. Both the MHRA and the European Commission have issued guidance on whether a healthcare app can be considered a medical device based on specific key- words. If an app is designed to ‘diagnose’ or ‘monitor,’ a patient’s condition it will be regarded as a medical device. However, apps that, for example, remind pa- tients that they have a medical appointment come into the consumer application category. It’s not difficult to see how apps could be put into the wrong category. This would not only cause confusion and probably prompt a recall, but it will also expose brands to reputational and operational damage and, even more worrying, present a health risk to consumers. Whether it’s a consumer app or a faulty wheelchair, manufacturers across the sector will find that exe- cuting a recall is no easy feat and requires plenty of preparation. With increasingly complex domestic and international supply chain arrangements, and strict regulations, it is critical that manufacturers have best practices in place to address the challenges of recall execution. For instance, documentation and trace- ability are two key areas that manufacturers should be focused on for regulatory compliance reasons and staying prepared ahead of a potential recall event. This should be a major component of a product recall plan designed to streamline recall response and ensure the organisation is prepared for the eventuality of an issue. In addition, all stakeholders from manufacturers and developers to distributors and even consumers must take ownership to ensure product safety. This collab- oration is critical, particularly when you consider that looking across all categories of products, the number of safety notifications and recalls has been on an overall upward trend since 2003, and 88% of those incidents were classified in the most serious threat category. It’s time for us all to work together. By Farzad Henareh, VP Europe at Stericycle ExpertSolutions.