27 Jun, 2017

New FDA Regulations Favor Digital Healthcare

 -New FDA Regulations Favor Digital Healthcare

Earlier this month, the FDA announced“The Digital Health Innovation Plan”. By implementing new regulations, the FDA is working to recognize how digital technology is revolutionizing healthcare. Led by The Center for Devices and Radiological Health (CDRH), the new regulations are set to be in place by the Fall. 

Back in March, we took at look at digital health and identified the lack of regulatory clarity as a significant challenge.

Thanks to the FDA, these regulations will provide this missing clarity to technology developers and healthcare industry stakeholders alike. In particular, this move answers many questions regarding the use of health apps and fitness trackers.

Apps and trackers have created a “health aware” generation. Mobile technology has empowered the “on-demand” patient to monitor their own health. The uptake of this technology has changed how the healthcare system operates, opening up new opportunities as to how we:

  1. monitor health conditions
  2. connect with medical professionals
  3. promote a healthier lifestyle

With this new regulation from the FDA, the process of how mobile health apps and fitness trackers can be utilized by healthcare providers is becoming clear.

This regulation is an important milestone on healthcare’s digital transformation journey.

Here’s what you need to know about the new FDA regulations.

New Pilot Program

Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration outlined the new regulations through a blog post. 

Using a pre-certification pilot program will allow lower-risk digital health products to be released on the market without an FDA review, whereas higher-risk products will need an FDA review before being released.

These guidelines were created in hopes to uncover whether companies are using high-quality software design as well as if they are frequently keeping up with maintenance for the app’s software.

“Certification could be used to assess, for example, whether a company consistently and reliably engages in high-quality software design and testing (validation) and ongoing maintenance of its software products.” Scott Gottlieb outlined.

It is important for a company to continuously test maintenance of software products to make sure the software remains a quality product that benefits the customer.

Regulating a company’s software design and testing causes stricter guidelines that companies have to abide by, which could change the way innovators conduct the process of creating a health app or fitness tracker.

“Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.”

The FDA hopes that with stricter guidelines for software, time and cost will be reduced for market entry for technology.

Through this pilot program, the FDA aims to approach technology in an efficient way through a framework of regulations, which will ultimately result in useful developments.

Using Data

The FDA has formed alliances among data sources to launch a system called The National Evaluation System for Health Technology (NEST).

This system is being created in order to urge product developers to use real-world data in order to further evolve functions such as electronic health records, player claims, and strategic alliances.

Medical Device Innovation Consortium (MIDA), a nonprofit created in order to improve medical technology, will support this system by acting as an independent control center.

NEST will offer real world data in order to effectively expand market entry for products which will assist in further developing tools that will uniquely benefit both the consumer and innovator in new ways.

Promote Public Health

The first concern that the FDA has expressed by implementing the new regulations is to make sure that technological developments remain safe for customers and provide them with effective information that will only further benefit the health market.

“For these and other digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation.”

Using modern technology to improve health is a priority among the digital transformation landscape, and these regulations provided by the FDA will further navigate to result in safe and effective developments through app software.

Put Innovators on the Right Track

The FDA is also concerned with encouraging innovators to invest in ventures that will only result in being successful and beneficial for both the market and the company. 

“in this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures.”

Creating regulations for digital healthcare makes the development of health apps and fitness trackers a more exclusive, monitored process that can provide innovators the tools needed to understand what their essential role is in the healthcare industry.


Digital Healthcare Transformation AssemblyWith the new FDA regulations affecting digital transformation in healthcare, it is unknown how innovators and businesses will be affected. What is known is that the healthcare landscape is changing and emerging to be a digitally aware industry. Healthcare mobile apps and fitness trackers are constantly developing allowing patients to have more access to health records, impacting patient-professional relationships.

Since customers in the health industry are shifting their interest toward health aware apps, and fitness trackers, It is more vital than ever to be open to new technologies that are emerging into the market in order to stay connected to the consumer. Being up to date with the rise of new FDA guidelines will give an insight into how these tools are developed and how the customer is ultimately affected.

The Millennium Alliance is pleased to announce that application for our biannual 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.

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