Seven Key Concerns Surrounding Apple's ResearchKit as It Moves Toward IPO Filing

The most significant recent news in the realm of internet healthcare undoubtedly stems from Apple’s release of ResearchKit, a mobile software platform designed to assist medical researchers in data collection for clinical studies. While ResearchKit has sparked considerable expectation, it has also drawn substantial skepticism. To assess the ultimate impact of ResearchKit, how do you evaluate its potential in light of these industry concerns? An article from MobiHealthNews prompts us to reflect on this question; VCBeat has curated and translated it for our readers.

On a television program, Apple CEO Tim Cook discussed the topic of internet healthcare with Jim Cramer, host of Mad Money, stating that the internet healthcare market is currently significantly undervalued.

Cramer: “There are many new developments emerging, such as the Internet of Vehicles and mobile cloud computing. While these forms are novel, I do not consider them to be the most representative.”

Cook: “Yes, I believe the healthcare industry holds the most promise and has the greatest potential to disrupt society. For a long time, people have relied on others to maintain their health. With new tools like ResearchKit, individuals can monitor their own health, which makes it incredibly valuable.”

Cramer: “My cardiologist, who is involved in the Stanford project, has a profound understanding of this. With emerging software, doctors can monitor my health status in real time; conditions such as hypertension, obesity, and even cancer can be detected promptly. This is because the relevant data speaks for itself, even if I do not explicitly tell my doctor where the problem lies. That is the great value of those excellent apps or HealthKit.”

Cook: “That is indeed the case.”

Since it is open source, what about Android?

Fortune magazine’s Dan Primack once pointed out that since ResearchKit can provide researchers with a vast source of data, this database should be sufficiently large, containing massive samples.

“Only 14.8% of smartphone users use the iOS system, while 81.5% use Android. Since ResearchKit runs on iOS, this indicates that a significant proportion of patients are excluded and cannot serve as research subjects.”

Jonah Comstock of MobiHealthNews examined the obstacles involved in porting ResearchKit to other smart systems, such as Android. First, it remains uncertain whether the platform will collaborate with Android devices. There is a certain rationale behind Apple’s five apps being exclusively available on iOS: the sensor chipsets used in these apps—such as gyroscopes, accelerometers, and GPS—are highly similar, which facilitates data standardization for scientists. Porting to Android phones would first require overcoming the hurdle of standardizing disparate hardware.

However, the lack of Android support also means that ResearchKit suffers from a lack of data diversity. In the United States, compared to the tens of thousands of non-Apple mobile phone users, Apple users are generally younger, better educated, and wealthier. For example, black smartphone users are more likely to use Android systems than white smartphone users, and the average annual income of Apple users is $85,000. However, the incidence of obesity and heart disease is extremely high among African Americans in the United States, the average age of Parkinson's patients is 62, and asthma is mainly distributed among children, low-income families, and ethnic minorities. There are countless such examples.

Is it feasible for the patient to have no face-to-face communication with the investigator?

ResearchKit plays a prominent role in the treatment of chronic diseases. By leveraging smartphones to build extensive databases, it reduces the research costs associated with these conditions. Another highlight of this technology is its ability to connect apps with external wearable devices or monitoring instruments, such as inhalers. However, uncertainties remain, including whether patients will voluntarily submit data to researchers and whether disease conclusions drawn solely from smartphone data are sufficiently reliable. Therefore, some researchers believe that ResearchKit should serve only as an adjunct to traditional medical care.

What Should You Do When the Novelty Fades?

Initially, most users actively participate and submit data out of curiosity. However, as time goes on, user interest wanes, rendering the early-stage data less valuable for research purposes. Therefore, it is essential to strike a balance between the volume of data collected and its accuracy. Determining which factor takes precedence will be the primary consideration in the practical application of this platform.

What if the app cannot distinguish between authentic and falsified data?

Developers rarely account for deceptive practices such as data fabrication, as intentional fraud is difficult to comprehend and thus unlikely to occur. However, users may record data via the software for a week or two out of curiosity or for fun, but sustaining this practice for 52 weeks proves challenging, particularly given the absence of any monetary reward.

Furthermore, for example, if I were to sign up as a research participant for studies on obesity, Parkinson’s disease, asthma, and other conditions despite not actually having these diseases, how would ResearchKit distinguish such irrelevant, interfering data? Even if it could identify such data, the cost of cleaning this “noise” would be prohibitively high, making it economically unviable. Therefore, only by enrolling high-quality, verified patients can truly valuable data be obtained. In short, garbage in, garbage out: data from individuals without the specific disease or with atypical presentations should be excluded from the study scope, as they merely introduce confounding interference.

Applicable to only a very small number of diseases?

Experts have poured cold water on the idea, stating that iPhone data is only useful for specific diseases. Even stronger opposition argues that ResearchKit and HealthKit are mere showpieces—visually appealing but impractical and overly idealistic—failing to attract consumers. Both are built on shaky foundations.

What Are Apple’s New Regulations for iOS Developers Using ResearchKit?

It specifies the scope of permissible apps. If an app intends to utilize the HealthKit framework or access data through ResearchKit, it is subject to restrictions and must comply with applicable laws. Consequently, Apple restricts data mining or sharing with third parties. Apps intended for commercial purposes, such as advertising, or for the purpose of mining other information, will not be permitted.
For legitimate medical research purposes, data will be obtained only with the patient’s informed consent. The application must include the following justifications: the nature, objectives, duration, procedures, risks, and benefits to patients of the study; confidentiality measures and data handling practices; contact information and procedures for terminating collaboration.

Can researchers resell data to third parties?

The generation of data inevitably gives rise to concerns regarding privacy protection and data misuse. Organizations typically claim that patient data is used solely for medical or healthcare-related projects; however, the scope of this assertion is so broad that it becomes difficult to believe any meaningful privacy confidentiality remains for such information.

The First 5 Apps Launched

1、 Asthma Health by Mount Sinai

Since the launch of the app, 2,500 volunteers have registered. Patients can use the app to record their symptoms and how these conditions affect their daily lives, both day and night. The app also logs the usage of controller or rescue inhalers when asthma triggers are present, such as colds, increased physical activity, strong odors, dust, pollen peaks, and exposure to animals. Furthermore, it tracks emergency room visits, physician consultations, changes in medication, and other relevant factors, with real-time data updates. Volunteers participating in this project must be at least 18 years old, have a physician-confirmed diagnosis of asthma, and be currently undergoing pharmacological treatment for asthma. Individuals who smoke, have other pulmonary diseases, or suffer from congestive heart failure are excluded from participation.



2 、Share the Journey

This app is designed to analyze why some breast cancer patients have longer survival times than others, the reasons for disease progression over time, and how to improve the quality of treatment. Data on five major clinical features of breast cancer—fatigue, mood, cognitive changes, sleep disorders, and changes in physical activity—are collected through questionnaires. ResearchKit extracts data from HealthKit, such as step count, sleep patterns, date of birth, height, and weight. Collecting these data requires less than 20 minutes per week.



3、 Parkinson mPower study app

Following its launch announcement, the app received registration information from 5,589 volunteers. “mPower” stands for the global mobile observational evidence-based research platform for Parkinson’s disease. As Parkinson’s symptoms fluctuate daily, these changes previously could not be tracked and monitored in a timely manner. Now, this app enables real-time monitoring of the condition through a series of patient activities, such as memory tests, finger tapping, speech, and gait analysis. Additionally, it can collect data from wearable devices. Although it focuses on advancing Parkinson’s research, researchers encourage individuals to download the app regardless of whether they have been diagnosed with the disease.



4、 GlucoSuccess

This app enables hospital researchers to collect extensive data on dietary behaviors and blood glucose levels from individuals with type 2 diabetes, while also guiding patients toward healthier eating habits to prevent blood sugar spikes. Patients record data including exercise volume and intensity, dietary intake, blood glucose measurements, body weight, and waist circumference. Integrated with the LoseIt app, it reminds users to log their blood glucose levels and daily caloric intake, thereby helping patients better understand their condition and health status. Eligibility for enrollment is restricted to individuals aged 18 years or older, residing in the United States, and diagnosed with prediabetes or diabetes.



5、 MyHeart Counts

Following its release, the app attracted 11,000 registered users. Its data recording method requires integration with the Apple Watch, utilizing the watch’s heart rate sensor or third-party wearable devices for data collection. Additionally, users are invited to participate in a six-minute walk test. If users also sync their cholesterol and blood pressure data, the app can further calculate their risk of developing heart disease and determine their “heart age.” Eligibility criteria include being at least 18 years old, residing in the United States, and having proficiency in English.