What Apple’s Health Records update means for the clinical trials industry

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/demaerre)
(Image: Getty/demaerre)

Related tags: Clinical trials, Clinical trial

Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata.

The updated Health Records section within Apple’s Health app enables users to aggregate health data from disparate electronic health records (EHR) on their iPhone.

(Image: Apple)
(Image: Apple)

Data is encrypted and protected with the user’s iPhone passcode, according to Apple, which made the announcement last week.

Among the first to bring the feature to patients includes Johns Hopkins Medicine, Cedars-Sinai, Penn Medicine, and other participating hospitals and clinics. Additional medical facilities are expected to provide patients access to the feature in the coming months.

Transforming research

Joe Dustin, principal, Mobile Health, Medidata Solutions said the new feature has the potential to fundamentally change the way research is conducted in an academic setting and in regulated clinical trials.

If patients can finally download their own data, they will be able to share their data. A whole new ecosystem of health apps from companies who want to put your health data to work for you​,” he told Outsourcing-Pharma.com.

This new feature from Apple is the first of many that could transform research in a few different ways.​”

As Dustin explained, if patients are able to aggregate their health data, they can also share that data.

That means very soon, the systems used to run clinical trials would be able to consume eSource data directly from patients,” ​he said, which bypasses the need for EHR integration.

It also means patients would have an easier way to get their data back from procedures performed in a clinical trial​,” added Dustin. “Giving data back to patients is a highly requested feature​.”

Dustin also poses that Apple’s Health Records will have the ability to enhance patient recruitment – a longstanding industry challenge.

Today, regular people are barely informed about clinical trials even when they could be a good fit​,” he said, explaining that the new feature could make it easier to find the right people to participate.

Once the feature is utilized by more people and those people voluntarily share their data with third-party services, new apps, or even patient communities around a specific disease, this would enable a direct connection to patients and allow for solicited outreach to the right people at the right time.”

Mobilizing clinical trials

The industry touts virtual clinical trials as the future of research, one in which participation could be greatly improved through the use of mobile applications that recruit, engage, and capture patient data – while reducing patient burden.

We have seen virtual clinical trials pave the way for a future that is evolving fast​,” said Dustin, citing GlaxoSmithKline’s PARADE study, which marked the first use Apple’s ResearchKit application by a major pharmaceutical company.

This app had an enrollment and registration step in the patient onboarding workflow to ingest data from Apple’s HealthKit which included some simple demographics​,” he explained.

Moving forward, when a research app is released, patients will have the option to share their health records data as another source inside HealthKit. 

Dustin said, “This opens up a wonder of possibility for researchers and pharmaceutical companies that want to take a more personalized approach to medicine and also improve the patient user experience that could attract more to participate in clinical trials​.”

Taking the plunge

Seventeen years ago Apple disrupted the music industry with the release of the iPod. Today, Dustin said the company’s new release should excite those who work in the life sciences industry, as well as those who are trying to improve the healthcare and health-IT ecosystem. 

“Apple has always been a first-mover in industries that are ripe to be disrupted​,” Dustin added, asking: Why can’t the life sciences industry be disrupted faster? 

My feeling is that we have been on that ledge for some time and now it’s time to take the plunge​,” he said. “Resistance is futile. Once you give information to the people, innovation has an easier path to move​.”

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