23 Aug, 2017

What Does The FDA’s Pilot Plan Mean For Healthcare?


As the healthcare industry moves toward digital transformation, The FDA is forced to keep up with its regulations to approve all of the digital tools that are emerging.

In June, The FDA released new guidelines that promoted digital health efforts, in order to bring them to the forefront of the healthcare industry.

This new healthcare strategy was outlined by the FDA’s recently-appointed commissioner Scott Gottlieb, addressing the steps that the agency is going to take to support digital health.

Last month a blog post was released, outlining further steps the FDA is planning on taking, to further guide the health care sector toward embracing a digital market.

“Historically, healthcare has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that’s been cited, among many, is the regulation that accompanies medical products. But momentum toward a digital future in healthcare is advancing. Not all of these tools are subject to FDA regulation. For the devices we are asked to evaluate, we know that our policies must continue to empower consumers and facilitate innovation.” Taken from the FDA blog.

Since then, a buzz surrounding these new regulations has been apparent among the healthcare industry. Let’s take a look at what the FDA is trying to implement.

Pre-Cert for Software Pilot Program

According to the blog post, the Pre-Cert for Software Pilot Program has been formally launched, which focuses on innovation by embracing digital health tools.

The FDA is moving toward supporting medical devices that are digital centered, instead of traditional. According to the FDA, the goals are as followed:

  • Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion.
  • Ensure high-quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence.
  • Be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

The FDA is embracing digital health technologies in order to be used in the prevention, treatment, and diagnosis in patient care, in hopes they will work to save patients’ lives.

Some of these digital tools that will be supported by the FDA are mobile health apps that engage customers to monitor their own health, which has substantially changed the way the healthcare industry operates.

We talked about digital health app start-ups on a Digital Diary post. If you missed it, you can catch it here.

The FDA is planning to monitor the software that is being used in this technology, that is released on the healthcare market in order to move forward.

So, what does this mean for healthcare companies?

Less Regulation, More Innovation

As part of the pilot program, FDA will limit regulations on digital health companies who have proven to develop and release quality and effective products on the market.

This welcomes health developers to continue to make digital health tools, which pushes the industry toward digital transformation and innovation, as opposed to hindering the progress.

The FDA will continue to evaluate applications to fill the program, which has 9 open slots. This program will be used as a test center, fostering innovation through pre-certification requirements.

Ultimately, the program would allow the FDA to regulate developers rather than the software itself, allowing some precertified developers to immediately launch a product and begin post-market data collection.” Fiercehealthcare reports.

These new strides in the healthcare industry give players more freedom to create products, that will further move the healthcare industry digitally forward, and the industry is very happy about it.

It will be interesting to see the new startups that will continue to emerge. As we have reported in the past, startups are expected to be the “future of healthcare.”


The Millennium Alliance is pleased to announce that application for our bi-annual Digital Healthcare Transformation Assembly is now open!

Seats are reserved for the C-Level executives leading the digital healthcare revolution to come together on December 5-6, 2017.

Limited sponsorship opportunities are available. Download the Digital Healthcare Transformation Assembly Sponsorship Prospectus for more information >




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