Apple and Johnson & Johnson announced this morning the launch of their new digital health study exploring the impact of Apple’s devices and a study-specific engagement program on cardiovascular outcomes among the Medicare population.

First announced in early 2019, the Heartline Study — which also names Evidation Health as a collaborator — is now enrolling seniors aged 65 years or older who are on traditional Medicare, and also own an iPhone 6s or later smartphone. These participants, the companies say, can sign up for the study remotely by downloading the Heartline Study app and releasing access to their personal Medicare data.

“Through this important collaboration with Apple, we are pioneering new models that we hope can break down some of the most common barriers to participation in clinical studies,” Dr. Paul Burton, VP of medical affairs for internal medicine at Janssen Scientific Affairs, said in a statement. “Our work continues to develop and deliver solutions for those impacted by [atrial fibrillation] in the areas of detection, treatment and care, through novel approaches, so that we can potentially improve their lives today and well into the future.”

Enrolled seniors will be randomly assigned to two study groups. The first of these will only be using their iPhone and the Heartline Study app, which is designed to engage users with weekly health education, tips, surveys and questionnaires. A second group will also be provided with an Apple Watch so that they may incorporate the device’s on-board ECG and irregular rhythm notification feature into their personal health monitoring.

The Heartline Study will consist of two years of “active engagement,” and an additional year of follow-on data collection. Through this period, the companies said they will be looking for any changes in stroke risk and atrial fibrillation detection among the study population.

WHY IT MATTERS

App-based digital health studies like these enjoy higher rates of enrollment and lower overhead costs. Recently published study data, however, suggest that such designs are also subject to greater turnover and predominantly younger samples.

Heartline, however, will be enrolling a much older cohort that is generally much more conscious of their health conditions. As such, this effort will be noteworthy in multiple regards: as an exploration of how a digital program and Apple’s consumer devices and features can engage users and improve their health; and as a look at whether this type of decentralized study design will find an audience among seniors.

“Heartline is a study that has the potential to fundamentally change our understanding of how digital health tools, like the ECG app and irregular rhythm notification feature on Apple Watch, could lead to earlier detection of [atrial fibrillation], helping patients understand and directly engage in their heart health, prompting potentially life-saving conversations with their doctors, and improving health outcomes,” Dr. C Michael Gibson, founder of the PERFUSE academic research organization at Beth Israel Deaconess and co-chair of the Heartline Executive Committee, said in a statement.

THE LARGER TREND

Apple CEO Tim Cook has long been vocal in his belief that Apple will soon be a major player within healthcare, and so far the company’s devices have already been featured in a handful of wellness programs from UnitedHealthcare, Vitality Group and others.

But the company has also gone big on clinical research partnerships over the past few years. It kicked off the Apple Heart Study with Stanford back in 2017, and announced those results early in 2019. Since then the company announced and launched three more studies also employing the Apple Watch’s various health tracking features, which consumers can enroll in by downloading the company’s Research app.

ON THE RECORD

“Apple technology is making a meaningful impact on scientific research through the powerful capabilities of iPhone and Apple Watch, all with privacy at the center of the participant experience,” Myoung Cha, Apple's head of health strategic initiatives, said in a statement. “The Heartline Study will help further understanding of how our technology could both contribute to science and help improve health outcomes, including reducing the risk of stroke.”

British AI chatbot and virtual care company Babylon is used to getting shade from the public and the medical community alike. But recently it went a step further to strike back at one of its most prominent critics. 

For years, a Twitter user under the handle of @DrMurphy11 has posted his encounters with Babylon's tool based on hypothetical situations. On the whole his tweets have been critical of the chatbot and highlight inaccuracies and issues among its responses. Last night he went public on the BBC as Dr. David Watkins, a consultant and oncologist. 

Babylon fired back at the tweets by posting details of @DrMurphy11’s searches publicly on Twitter. The company reported that Watkins spent the equivalent of five weeks testing the system and ran 2,400 tests. According to the company, he raised issues with less than 100 test results. 

“At every stage, we have attempted to start a positive conversation with this anonymous person. We have invited him in to start a dialogue, to test our AI and to meet with the senior doctors who build our products,” the public statement from Babylon wrote. “We have corresponded with him openly and honestly when he has brought issues to our attention. We have repeatedly opened our doors, but revealingly he prefers to troll on Twitter. He refused to meet us and instead posted over 6,000 misleading attacks.”

The release ends with Babylon offering Watkins a way to connect with its team. 

“So today we’re making a big offer: @DrMurphy11 now that you have stepped out from behind your computer, why not be part of an open, independent analysis of your AI testing: publish the entirety of your work, and let the totality of your data be assessed by any objective expert.”

WHY IT MATTERS 

This release of data has lead to a wave of backlash against Babylon on Twitter. Some called the company's release “bullying”, while others pointed out the value in Watkins' work. 

“It is very strange for @babylonhealth to describe someone as a 'Twitter troll' when that person is doing them a substantial service (for free) by identifying deficient algorithms,” Twitter user @Melichior wrote. 

The move has also called into question the handling  of user’s data and privacy — in particular in the age of tightening data regulations like GDPR. 

“There are other big issues about data and confidentiality of users here,” Twitter user @Mgtmccartney wrote.  

MobiHealthNews reached out to Babylon for comment on the ethics of sharing a user’s data and the considerations it took before sharing, but did not not get a reply before the time of publication. 

THE LARGER TREND 

This isn’t the first time Babylon has come under fire for its research. Last year saw a case where a head-to-head comparison in which the service triumphed over live doctors was highly contested by professional groups, and it wasn’t long before NHS officials began delaying rollouts of the GP at Hand app due to patient safety concerns.

However, the virtual health company is growing. News broke late last year that the company was set to launch in the US. This comes after Babylon’s gargantuan summer funding round, which was led by Saudi royals. As a part of this funding the company said it would expand to the Middle East and China alongside North America. The company has already seen rollouts in Rwanda and and Canada, as well as in its home country via longstanding deployments with the UK’s National Health Service.