In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.
Digital health technologies, including healthcare apps, have the potential to offer alternative healthcare pathways and, if utilised correctly, have the power to transform healthcare. But do healthcare apps risk being defeated by a lack of patient engagement?
This week the Secretary of State for Health, Jeremy Hunt, announced that the Government will be investing £4.2 billion in digital health initiatives. The investment is part of the Government’s latest drive to create a “paperless” National Health Service (NHS) by 2020. The full details of the funding are still being agreed between the Department