How Will The Digital Health Innovation Plan Change Tech In Healthcare?
In response to the latest tech developments, the FDA recently announced a “Digital Health Innovation Plan,” meant to encourage companies to develop new technologies safely.
Digital health is a growing revolution, with mobile devices, big data, and other new technologies enabling new, better forms of patient care. Unfortunately, the road to increased healthcare sophistication isn’t a straight one; with every new tech development, there are new patient concerns, new potential liabilities for caregivers to consider, and new regulations for the government to impose for safety and order.
The Digital Health Innovation Plan
So what is the Digital Health Innovation Plan (DHIP) doing? There are many intentions and regulations to consider here, and the plan could influence an entirely different wave of new laws. However, for now, you can think of the plan as unfolding with four main goals:
Adding clarity and specificity to guidelines for medical tech
Manufacturers face frequent slowdowns during the research and development phase, as existing specifications and guidelines for medical tech are somewhat vague. Digital healthcare is still new, and there aren’t many concrete regulations, so they often need to seek approval and guidance on a case-by-case basis. This plan would give manufacturers more specific information to work with.
Decreasing regulation of technologies considered “low risk”
Some technologies are inherently safer than others. This plan would strip down the rules regulating low risk tech to get it to market faster, and encourage more innovation.
Partnering with NEST for more efficient data collection and use
The FDA intends to pair up with the National Evaluation System for Health Technology (NEST) to collect more post-market data, which can be used to drive even more innovation.
Launching a pre-certification program for SaMD
Software as a medical device (SaMD) is a growing field of interest for developers, and the FDA’s plan intends to create a pre-certification program to allow it to be developed faster (and therefore enter the market faster).
How Pharmaceutical Companies Need to Adapt
As you might imagine, if pharmaceutical companies want to continue thriving after this plan begins rolling out, they’re going to have to adapt. The world is still going to need drugs and medicine, and pharma companies can provide them. But according to Clarkston Consulting, consumers are going to start demanding service “beyond the pill,” and new tech may grow to rival what big pharma can offer.
In order to stay competitive, big pharma is going to need to do one of two things. Companies will either need to start launching new wings of tech development, in order to provide more thorough care for their customers and keep up with their competitors, or they’ll need to partner up with tech startups to get a direct line to new innovations.
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