Dr. Amy Abernethy, the principal deputy commissioner and acting chief information officer of the Food and Drug Administration, said the agency is looking at com...
Our cloud strategy is intended to make the use of the cloud easy, fast and cost effective. And that's because our cloud strategy underpins our entire IT modernization and data strategy. In order to get there, there are three core elements access, use and security.
Principal Deputy Commissioner, Acting Chief Information Officer, Food and Drug Administration
We created a new governance model that had several features. One was each of the business units or product centers, as we call them, has not only a technical representative, but they have a business representative. And then both of those individuals have to be high enough in the organization to represent decision making.
Principal Deputy Commissioner, Acting Chief Information Officer, Food and Drug Administration
[I]n the context of the technology modernization action plan, I mentioned that middle category of technology modernization strategy, where we are building tools and solutions where people can see ‘Oh, now I get it. Here's how our technology organization can help us.
Principal Deputy Commissioner, Acting Chief Information Officer, Food and Drug Administration
When we think about what is the core that keeps FDA humming, what we do is review data in order to make decisions about the products that we render. Data is the fundamental element to how we make our regulatory decisions every day.
Principal Deputy Commissioner, Acting Chief Information Officer, Food and Drug Administration
The Food and Drug Administration is about a year into its IT modernization strategy that focused on three core elements: A modernized IT infrastructure; the ability to demonstrate capabilities of a modern technology and data organization; and the constant communication with stakeholders and other experts to ensure the technology doesn’t fall behind.
In the end, the FDA’s IT modernization strategy really is about one thing: data.
“When we think about what is the core that keeps FDA humming, what we do is review data in order to make decisions about the products that we render. Data is the fundamental element to how we make our regulatory decisions every day,” said Dr. Amy Abernethy, the principal deputy commissioner and acting chief information officer of the Food and Drug Administration, on Ask the CIO, sponsored by Vion. “Practically speaking, the way that we think about data, the way that we use data at our agency also informs how we’re going to have the capabilities to use data efficiently as we make our regulatory decisions.”
While Abernethy, who is a hematologist/oncologist and palliative medicine physician and an internationally recognized clinical data expert and clinical researcher, never underestimated the power and value of data, the need for an enterprise data strategy became clear almost immediately after issuing the IT modernization strategy.
She said the time period to set up new cloud services and other related modernization efforts wasn’t going to take as long as she expected.
“Because the criticality of data, artificial intelligence and how we’re going to use data in the future was also sitting right in front of us,” Abernethy said.
That data and those emerging technologies depend on the FDA having a modernized infrastructure and that means moving more to the cloud.
Abernethy said the agency’s cloud strategy is focused on making the move easy, fast and cost effective, and of course, secure.
“Our cloud strategy underpins our entire IT modernization and data strategy,” she said. “In order to get there, there are three core elements: access, use and security. So firstly, focus on access. We’re doing this by fundamentally rethinking our traditional network design, which historically assumed that everything would be internal and protected by this hard secure perimeter. Now we need to move to a new environment where data and people may be literally anywhere. This distinction of what’s inside and outside is blurred.”
Under security, Abernethy said FDA is moving to concepts such as software defined networking and zero trust principles as part of their new network design.
“The goal behind the new network design is to make it really easy but secure, and be able to collaborate with people and data anywhere at any time,” she said. “We’re taking a product or package service approach. Instead of every cloud activity being looked at as a custom project, we’re looking at common use cases and creating package services that can be deployed really easily or as a self-service that gives the customer the majority of the capabilities they need. And then we can layer on top or customized for the remainder of their needs. This package service concept helps us both accelerate and standardize what we do in the cloud and really starts to accelerate our move to cloud.”
The third piece of this cloud strategy, security, requires even more consideration because of the distributed environment and collaboration the FDA works within.
The cloud is not a new concept for the FDA. Former CIOs started this process as far back as 2012 and the expansion of cloud services continued throughout the past eight years.
Abernethy said her goal with cloud services is all about acceleration.
“How do we do so in a way that’s packaged so that our customers inside the agency can understand what we’re doing? So we need to be able to communicate to our agency customers and then our stakeholders outside the agency. Why we’re moving to the cloud and what the solutions look like so that they can understand them. We need to make sure that we have pressure tested what is going to work and package it in a way that can now be served up to our customers,” she said. “As I talk about our acceleration to the cloud, that core additional focus has been on the customer.”
The customer-focused approach also is at the center of a new initiative to create enterprise or standards products that mission offices can plug into.
Abernethy said this product service initiative depends on strong governance and collaboration processes that her office is starting to put into place.
In the meantime, the FDA continues to modernize applications and other critical mission capabilities.
“Rather than doing like for like upgrades in our on-premise environment, we look toward how can we move those to the cloud? Practically speaking, as we get into end of life or close to end of life, that’s our highest priority,” she said. “We then also look for opportunities to how we can rapidly retire many of our data centers. When I first arrived in FDA, it generally surprised me that we have at least five data centers. We’re working on mapping a path to getting us and our applications to environments that release our data center space, and those that release the most data center space gets the next level of priority for us. We see this move to the cloud to be a long-term plan. We’ve been essentially taking steps down the path of our plan in a prioritized nature and asking, ‘What should we do first? What do we do second?’ and then also how do we make sure that our customers all across the FDA are also getting comfortable with this move to cloud?”
As far as the focus on data, Abernethy said she will release the enterprise data strategy later this calendar year and recently hired a new chief data officer, Ram Iyler, in March, where he has been meeting with mission and external customers to better understand their needs.
“The first element of the enterprise data strategy is going to focus on how do we make sure that we have the technical organization ready for the enterprise data strategy, That will also include, for example, a data lake strategy, appropriate security and thinking a lot about sort of access, and read write and inputs,” she said. “The second part of our data strategy is going to focus on the data itself. How do we aggregate data? How do we link data? How do we think about the appropriate governance of data privacy? So what are the issues as it relates to the data itself? And how are we going to as an agency start to advance our capabilities because we think about pulling data sets together to fill in data gaps, which, ultimately in this data access component, a core question is data quality.”
She said the FDA deals with a lot of dirty data so improving the quality will be an important focal point.
Finally, the third part of the data strategy will be about using data to drive decisions and more value.
“One of the best ways to improve data quality is to use that actually one of the best ways to get the entire community understanding what’s possible is to use data,” Abernethy said. “As I think about putting data to use, that’s going to include analytics, it’s going to include data storytelling and visualization. It’s going to include making sure that we think about novel capabilities, including artificial intelligence and blockchain.”
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