How Will The Digital Health Innovation Plan Change Tech In Healthcare?

How Will The Digital Health Innovation Plan Change Tech In Healthcare?

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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.

In response to many of these tech developments, the FDA recently announced a “Digital Health Innovation Plan,” meant to encourage companies to develop new technologies safely.

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).

What It Means for Big Tech Companies

So what does this mean for big tech companies, like Apple, Google, and other big tech companies? It means we could start to see at least a partial transition in healthcare; rather than relying on big pharma companies to handle all the innovation, breakthroughs could start emerging from the tech sector. Big tech companies are already starting to dabble in creating their own healthcare products, such as Apple working on a way of diagnosing Parkinson’s disease, and Google leveraging the machine learning power of DeepMind to recognize all sorts of diagnostic criteria. When low-risk technologies become deregulated, and the rules for product creation become more clear, those investments are going to rise.

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.

How Tech Consumers and Medical Patients Will Be Affected

Tech consumers and medical patients have the most to gain from this new plan, even though none of the new rules and regulations are going to affect them directly. Instead, these changes are directed at manufacturers, researchers, and innovators. The end result is going to be a flood of new health tech hitting the market, and possibly, more reliable and safer tech as well. Competition between tech companies and pharmaceutical companies will flare up, and in response, consumers might start seeing lower prices or better offers for the services they need.

Technology is always evolving, and it’s hard to tell what’s going on in the minds of our leading tech innovators. However, the FDA is setting the stage for a radical transformation in the world of digital healthcare, and it’s hard to imagine a world where pharmaceutical companies and tech companies aren’t both striving to take advantage of it.