How Digital Health Apps Are Regulated
- by nyfst
- Posted on October 26, 2022
Digital health apps are increasingly being used as an alternative to traditional healthcare. They provide patients with remote monitoring, prescription management, and consultations. They have the potential to improve the sustainability of health care. But they also pose a number of challenges for the traditional regulatory frameworks.
The market for digital health products and therapeutics is booming. The global mobile medical app market is expected to reach $20.7 billion by 2027. However, digital therapeutics and digital care products are still in their infancy.
Currently, there are around 350,000 consumer health apps. Most are focused on wellness and fitness.
In addition to providing consumers with access to medical services, these apps can help physicians and healthcare providers reduce their travel. Many digital health apps offer remote monitoring of key patient health metrics, such as blood oxygen saturation. They can also allow for secure sharing of patient data with clinicians. But these apps have yet to be proven effective at creating positive health outcomes.
Despite their growing popularity, most digital health apps are not regulated. As a result, they can offer inaccurate clinical information or incorrect diagnoses. This puts users at risk.
Understanding the Basics of Developing a Digital Health App
Fortunately, there are several new programs that are emerging. These include Germany’s Fast-Track process and Belgium’s mHealthBelgium framework. These more advanced programs are able to create centralized avenues for market access and standardized processes for reimbursement. Manufacturers should engage with these programs to understand their benefits.
The Digital Health Application Act, passed in Germany, allows for digital health apps to be recognized as part of a recognized treatment program. The Organisation for the Review of Care and Health Apps helps governments and developers comply with these standards.
Spread the love Digital health apps are increasingly being used as an alternative to traditional healthcare. They provide patients with remote monitoring, prescription management, and consultations. They have the potential to improve the sustainability of health care. But they also pose a number of challenges for the traditional regulatory frameworks. The market for digital health…