18 Jan, 2018

What Are The FDA’s Goals For Digital Technology In Healthcare?


The FDA has not been shy when it comes to expressing how important digital intiatives are in the healthcare industry. Advancing digital health has been a priority for the FDA, and the agency has put forward important moves in the past few years in order to make this happen.

“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.” FDA blog reports. 

In 2017, the FDA made some pretty impactful moves to make sure that the healthcare industry is ready to take on digital efforts. These efforts include anything from electronic health records, to patients using portals to communicate with doctors and store important health information. These efforts have caused a stir in the industry, causing patients and doctors alike to question just how important, and secure, using technology actually is.

Patients have expressed concerns regarding the safety of having their health information online, and doctors are questioning just how efficient and reliable digital components are. Despite these questions, the FDA has been committed to making sure digital intiatives are taking place in healthcare.

Taking A Look Back

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 health care 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.

A month prior to this move, the FDA released a blog post, outlining further steps the FDA is planning on taking, that states the agency’s stance on the healthcare sector embracing a digital-focused 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.

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 put these moves forward in order to express the fact that they will be promoting healthcare players to embrace digital health technologies to be used in the prevention, treatment, and diagnosis in patient care, in hopes they will work to save patients’ lives. The tools that the FDA admitted they will promote includes mobile health apps that promote customers to monitor their own health, such as heart rate. These tools have changed the way the healthcare operates and has allowed for new players to be introduced to the sector. 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.

Moving Towards The Future

Since 2017 was such a busy year for the FDA and digital health, we can only draw some conclusions about what is next for digital health in the upcoming year. That is until the FDA released new statements reassuring the agency still has priority when it comes to digital health.

“Advancing digital health is one of several priorities for FDA in the coming year, according to a 2018 Strategic Policy Roadmap released (PDF) by the agency on Thursday that identified four priority areas “that will be the focus of additional policy activity in 2018.” Fierce Healthcare reports. 

So, what exactly is the FDA working on for the upcoming year when it comes to digital technologies? Firstly, the FDA has the goal in mind to create more guidance when it comes to the guidelines that were rolled out towards the end of last year that aim to foster medical devices, allowing manufacturers to make necessary modifications to products and software.

In the upcoming year, the FDA plans to make sure that there is clear guidance when it comes to these guidelines along with the agency’s new Software Pre-Cert Pilot Program  that was debuted in September, which incorporated companies like Apple and Fitbit to

“By monitoring and managing chronic health conditions and dietary needs using consumer-directed mobile apps and other mobile health tools, or using medical devices to connect digitally with medical professionals, consumers can take more effective control of their care and their medical information and clinicians can provide better medical care,” the roadmap stated. “Well-validated, digital technologies provide a significant opportunity to achieve all of these and similar goals.” Fierce Healthcare reports. 

All in all, the FDA is dedicated to making sure the healthcare industry will continue to move forward and incorporate digital healthcare initiatives into operations, such as software, products and all of the parties that are affected.


The future of healthcare is digital. With the FDA providing clarity with the launch of new regulations regarding digital technology in 2018, developers and healthcare industry stakeholders alike are working to transform the patient experience.

The healthcare landscape is changing. The on-demand patient increasingly favors digital technology and platforms. According to Pew Research, a third of Americas have gone online and searched symptoms, in an attempt to diagnose a medical condition. Consumers also use the internet to look up information about healthcare professionals, and facilities. Healthcare marketers are being forced to think digital for the first time.

The US healthcare industry is unique, as it markets direct-to-consumer or direct-to-patient. Digital marketing technology is enabling healthcare marketers to talk directly to consumers in a new, more engaging way. As the FDA continues to push digital initiatives forward in the healthcare industry, it is clear that digital transformation is not going anywhere in this sector.

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