Patient Engagement and Data Protection: Complying with Regulations in a Digital Age

With ongoing developments in technology and software, there are many more opportunities to foster patient engagement, giving patients the tools to find out more about various medical issues, keep track of health-related measures, and chart the course of their own treatment.

However, one of the critical concerns to deal with involves data protection. For example, if you’re creating a new app for patients to use, how do you ensure that any sensitive information they feed into it remains secure? And are you sure that you’re complying with HIPAA regulations and any other government and industry standards?

A recent article from Government Technology highlights some of these challenges. One of the points raised in the article is that HIPAA regulations are frequently complex or vague. It might not be clear how to apply HIPAA  requirements to a new app or another new way of transmitting patient information between patients, doctors, and insurance companies. Smaller firms and start-ups developing new kinds of medical communication technology are especially disadvantaged, as it’s quite expensive to hire legal specialists or other experts to ensure compliance.

Furthermore, the article points out how the FDA has taken a relatively hands-off approach to new medical communication technology and software – but that doesn’t mean that it won’t jump in at some point with new regulations that businesses will then need to comply with. The uncertainty about what regulations the FDA will pass and when makes life harder for companies. Businesses might innovate only reluctantly, with the fear that their product ultimately won’t meet government requirements.

However, others believe that the FDA’s more open-ended approach is ultimately beneficial, as it isn’t a good idea to define policies too rigidly from the outset. Ultimately, it remains up to companies to assess the potential risk of their products for patients and demonstrate to patients, doctors, investors, and government officials that they’ve minimized the risks.

The tension between innovation and regulation isn’t a new one. When adapting new technological innovations, companies must remain mindful about potential regulatory concerns (anticipating these concerns when possible) and ensure first and foremost that the risk to patients gets reduced as much as possible.

Navigate regulations in a global market

Find out more about the ins and outs of dealing with marketing regulations on a global scale at Digital Pharma Europe – the industry’s ONLY marketing event hosted at a pharmaceutical company. To learn more about this event, download the brochure or visit the website. Click here to register and be sure to mention Priority Code BLOG.

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