FDA creates new Unit dedicated to Digital Health

 -FDA creates new Unit dedicated to Digital Health

The FDA has created a new unit dedicated to Digital Health. As medicine and healthcare push for digital health tools to become the norm, the FDA is racing to catch-up.

The worlds of technology and health have been becoming more intertwined for the past few years. Today, machine learning powers more medical device software than ever before. Regulation needs to catch-up.

The FDA is working to catch-up with Silicon Valley. One of the ways they are doing this is by creating this new unit. Bakul Patel, Associate Center Director for Digital Health at the FDA is hiring 13 engineers, software developers, AI experts, and, cloud computing geniuses to help his agency regulate the future digital health care landscape.

Over the last year, the FDA has put out a series of documents that describe the agency’s current thinking on digital health, helping developers understand what FDA does and doesn’t regulate as a medical device.

What Patel has learned is that “We’ve been trying to translate the current regulation paradigm for digital. But what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.”

This shift in focus marks a huge leap forward for the regulatory body.

For technology companies looking to enter the healthcare space, the timing could not be more opportune. It comes at a time when huge firms like Google, Facebook, IBM, and Apple are investing heavily in new health or medical technology. Lasy year, Google’s venture capital spent one-third of its investments in healthcare. Apple is working not only in the wearable space but has also started to work closely with the FDA on an app to diagnose Parkinson’s.

IBM is another example of a company who has identified health care as a huge digital opportunity. Watson, IBM’s artificial intelligence software is being used for everything from treating cancers to discovering new drugs.

This step by the FDA to provide an agile regulatory system to deal with digital health is a huge boost to the industry.


Digital Healthcare Transformation AssemblyThe 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.

With the failure of Trumpcare, the start of the Obamacare repeal process has been delayed. What is certain is that the healthcare landscape is changing. The new government favors tax credits, less funding for Medicaid and Planned Parenthood, and giving Americans the option to purchase insurance out of state. What is not yet clear is how many Americans will be negatively affected by the changes. It is expected that several will lose their health insurance.

What is clear is that we are entering a time of uncertainty for both the industry and the patient. The need for customer-centric transformation is more vital than ever, to be open and transparent to patients as they navigate new policies. Healthcare systems and insurance carriers are being forced to respond to new demand rapidly.

The Digital Healthcare Transformation Assembly has been designed for all of our partners, affiliates, and members to once again gather in our unique format to develop new relationships, collaborate with like-minded peers, and learn cutting edge intelligence to take back home and help tackle the biggest business issues of today.

We will be addressing the most important digital marketing and business priorities of 2017 including:
Content Marketing and Social Media
The Future Of eHealth Systems and Health Data Analytics
Consumerism and Meaningful Technology Engagement
Data Analytics and Population Health
Consumerizing and Personalizing Connected Health

This is not just another “Digital Healthcare” event. Spaces are reserved for the best in the business. Find out more here >

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