May 17, 2020

The FDA is looking to develop a $100mn medical data enterprise

medical devices
Big Data
Catherine Sturman
2 min
Data is becoming increasingly essential for healthcare organisations. As the industry becomes further patient centered, technology will play a key role...

Data is becoming increasingly essential for healthcare organisations. As the industry becomes further patient centered, technology will play a key role in streamlining clinical development, where medical devices will provide individuals with a greater understanding of their healthcare needs. Technology will also work to support medical professionals in the prevention, diagnosis and treatment of long-term conditions.

By harnessing what the FDA has coined ‘real world data’ (RWD), described as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, including information obtained at the point of care,” RWD will also work to transform traditional clinic trials, where sophisticated data and reduced costs will lead to enhanced patient outcomes.

Whilst there will be continued investment in the FDA’s National Evaluation System for Health Technology (NEST), the organisation has a long-term ambition of creating a “natural resource,” whilst maintaining essential data security and compliance standards.

Through President Trump’s Fiscal Year 2019 Budget, the FDA has therefore submitted a $100mn medical data enterprise proposal to build a new system which would be bolstered by electronic healthcare record data of up to 10mn citizens, alongside other key RWD sources, such as insurance claims or mobile health devices.

“This is the next evolution in the Agency’s development of a comprehensive data enterprise to improve medical product regulation and better inform us on the safety and benefits of new innovations,” said Gottlieb in a recent blog.

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Through the use of clinical data from electronic health records, healthcare professionals will drive sophisticated reporting on the performance of medical devices in real time and transform complex regulations in line with modern healthcare requirements, providing individuals with essential information to enable better decision making.

It is imperative for healthcare organisations to remove barriers to communication and potential siloes, and data will remain central to this. The FDA’s budget request will therefore work to resolve any obstacles within interoperability, as well as establish essential data standards through data sharing.

It will also enable the development of effective new medical products and services.

“Most importantly, such a system will provide patients with better care and more informed treatment decisions,” Gottlieb stated.

“The wider use of real world data could decrease the cost of product development, while increasing our understanding of how, when, and in whom, to use medical products. It’ll allow us to use the post-market period to refine our understanding of medical products. And it’ll allow us to make reliable post-market information available to providers and patients to better inform their treatment decisions.”

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Jul 23, 2021

Advances in health "must ensure self-sovereign identity"

3 min
As plans to introduce vaccine passports are announced, CEO of Tento Mark Shaw explains that individuals must retain control of their personal data

The UK government has announced that from September onwards COVID-19 vaccine passports will be necessary to gain entry into places with large crowds, such as nightclubs. 

This has reignited the debate between those who believe having proof of vaccinations will enable people to gather in public places and travel safely, and those who view the digital certificates as an attack on personal freedom. 

The arguments have increased in intensity since the recent announcement to drop COVID-19 restrictions in England, in a move to reopen the economy that has attracted fierce criticism both domestically and overseas. 

Cross-party ministers are set to defy the government’s latest plans to introduce vaccine passports over civil liberties concerns. A number of MPs have already signed the Big Brother Watch declaration against “Covid status certification to deny individuals access to general services, businesses or jobs” in recent months. 

However Mark Shaw, CEO of Tento Applied Sciences, says the Big Brother Watch campaign is based on false assumptions. “Big Brother Watch puts forward a compelling argument based around civil liberties, but some of the assumptions they make are simply incorrect” he says. 

“For example, the BBW campaign claims that all Covid passes are discriminatory, counterproductive and would lead to British citizens having to share personal health information with anyone in authority, from bouncers to bosses. However, there are already privacy-first digital wallets that give individuals the freedom to store and share anonymised medical documents, work credentials and other types of documentation quickly, simply, and securely.

“I wholeheartedly agree that individuals should not be required to share their own personal health information with unknown third parties or with anyone in authority who demands it" Shaw adds. "But I strongly disagree with the suggestion that ‘events and businesses are either safe to open for everyone, or no one’. It creates a false dichotomy that either everyone is safe, or nobody is safe. If employers or event organisers don’t take action to properly manage workplace or venue safety, then they risk curtailing the safety and freedom of movement for the majority." 

The subject of personal health data is under scrutiny in the UK at the moment, following controversial plans for the NHS to share patient data with third parties. These have been put on hold following public criticism. 

Meanwhile a new report has found that the majority of the British public is willing to embrace digital healthcare tools  such as apps and digital therapies prescribed by a trusted healthcare professional. 
Shaw adds: “The vital point to make is this: innovations in health technology must ensure self-sovereign identity. This means the data held about an individual is owned by the individual and stored on their device. And, in the case of medical data, that data can be delivered from healthcare professionals to the device in an encrypted format, and the user chooses how they share their information."

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