Digital Health
The digital health industry is vast, spanning technologies such as mobile apps, wearable devices, clinical decision support tools, and artificial intelligence. These innovations are transforming healthcare by advancing wellness, enhancing clinical decision-making, enabling immersive therapies through virtual reality, and personalizing care with AI-driven insights. Yet, despite their potential, all digital health solutions share one challenge: navigating complex and evolving regulatory requirements, including those related to cybersecurity. To bring your product to market confidently and compliantly, you need a partner with deep expertise and proven experience. Covita Health Partners is that partner.
Navigating the regulatory landscape for digital health products can be complex, with important questions that must be answered early. Is your product considered a medical device? Which regulatory agencies have oversight? What is the appropriate regulatory pathway? What cybersecurity standards must be met? What clinical validation elements will be required?
Covita Health Partners helps you make sense of these questions and more, so you can move forward with clarity and confidence.
Software Lifecycle
The Software Development Lifecycle can also be difficult to navigate. CHP can help you ensure you have the right procedures and records at the right time to ensure not only that your organization is not overly burdened, but that you also have a smooth premarket review process. It’s also imperative to ensure cybersecurity requirements are met because if the digital health product is connected in anyway to a device, electronic health record, or similar, you may experience challenges in market adoption and commercialization if your customers don’t feel confident that the digital health technology won’t introduce vulnerabilities to their system. Even if the digital health technology is not “connected” in the traditional sense, you’ll still need to ensure the device complies with certain cybersecurity requirements for the US market.
How We Can Help
Digital health technologies are complex, and no two journeys are the same. At Covita Health Partners, we offer tailored support designed to meet you where you are and help you get to where you want to go. Our approach balances compliance with practicality, enabling your team to deliver safe, effective, and secure digital health products with confidence. Below is a snapshot of the many ways we can support your success.