FAQs

Frequently Asked Questions

General

How much experience with programming and/or database knowledge is required to use MyDataHelps™ Designer?

Prior programming or database experience is not necessary. The point and click project builder within MyDataHelps™ Designer is all you need to create your entire project.

How long does it take to build and test a project?

The time it takes to configure and test individual projects may vary depending on specific protocol requirements, so there is no “one size fits all” approach. Active configuration and refinement could only take a few hours, whereas protocol finalization and testing may take a few weeks or longer depending on overall project complexity.

How do participants complete surveys and interact with a project?

Participants can complete eConsent, surveys, active tasks, and manage device data directly on the MyDataHelps™ mobile (iOS and Android) app. Participants may also use the web to complete eConsent and surveys, however, active tasks (e.g., two finger tapping, memory test) are not currently supported on the web.

How does the MyDataHelps™ participant app increase participant adherence?

Participants find it more convenient to complete surveys on their mobile device compared to the traditional research method of scheduling and completing a phone call or visiting a clinic. Additionally, participants can be reminded periodically via push notifications to complete any outstanding surveys. Coordinators can nudge participants by sending targeted messages to only those that meet certain criteria.

Will I be able to change my project after I start inviting participants?

Yes, you can continually update survey instruments, modify schedules, and deliver tasks, even after a project has launched.

Can the participant app support multiple languages?

Yes, the platform is designed from the ground up to support multiple languages, with one of our initiatives supporting 38 languages.

Data security, legal and compliance

How is participant data secured?

We have designed our platform–and the security program around it–to comply with the security and privacy controls defined by NIST 800-53 Rev. 4 at the FISMA Moderate baseline. We regularly undergo external formal assessments by a FedRAMP-accredited Third Party Assessment Organization (3PAO). Based in part on these formal assessments, our platform has been granted an Authorization to Operate (ATO) by the National Institutes of Health (NIH). We strive to protect the privacy of the Personal Information we collect and hold but we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of data at any time.

Is MyDataHelps HIPAA compliant?

The MyDataHelps™ platform is built on top of the CareEvolution HIEBus platform, which has been securely handling protected health information (PHI) for over 15 years for hospitals, insurance companies, and other organizations. HIEBus is HIPAA compliant and Meaningful Use Certified. Role-based access control ensures that participant data is only exposed to individuals with the appropriate permissions.

What data do you collect, and how is it used?

See our App Privacy Policy for details.

Account and Billing

What does the free account include? How many participants can I add with this free product? Is there a time limit?

Once you create your free MyDataHelps™ Designer account, you can access a majority of the features available, including inviting and enrolling up to 100 participants in your project. There is no time limit in using the free version of the product.

A team at my institution already has an organization created in MyDataHelps™. Do I need to create a new organization?

If you plan to utilize the same surveys and instruments as an existing organization, you can request that the organization administrator add you as a user. You will then be able to create a new project within the existing organization and utilize the resources already created. If you intend to utilize a different set of surveys and instruments for your new project, you should create a new organization.

How do I upgrade my account if I have over 100 participants?

If your project plans to enroll over 100 participants, please contact us to upgrade your project.

Consent forms and electronic signatures

How do participants sign a consent form before joining a project?

Before joining a project in the MyDataHelps™ app, participants are prompted to complete the electronic consent form, which can optionally include their electronic signature. The participant can find their signed consent document within the MyDataHelps™ app, and the project team can include this information in their data exports, if desired.

Will my IRB allow me to launch an app using electronic consent through MyDataHelps™?

While each IRB may vary in their policies and procedures, we have worked with several research institutions that allow electronic consents. Many of these institutions have found that the electronic consent process is much more efficient than traditional print, sign, and scan processes.

Survey question and answer types

What types of survey questions are supported?

Currently, MyDataHelps™ surveys include, but are not limited to, the following question or step types: instruction, video instruction, question, form (multiple questions within one step), image capture, video capture, completion step, countdown step, and webview step (custom steps that allow for embedding HTML, CSS, or JavaScript in a survey). For a full list of current steps/questions, please create a free account and view the “Surveys” tab and explore the “Step” types in the right bar.

What type of survey answer formats are supported in MyDataHelps™?

Supported answers include but are not limited to yes/no, numeric (integer and decimal), free text, continuous scale, discrete scale, complete scale, height, weight, date, time of day, and value picker. For a full list of current answer types, please create a free account and view the “Surveys” tab and explore the “Answer Format” types in the right bar. If you do not see what you are looking for, please contact us as we are continually adding new functionality.

What if I want to add a step type that isn’t supported? Is there a way to extend MyDataHelps™ surveys with additional functionality?

You may create customizable HTML-based web view steps in MyDataHelps. As an example, a “digital body map” was created to serve as a self-report measure that accurately assesses the distribution of pain. JavaScript can be utilized to create highly interactive and sophisticated survey steps.

Is conditional or branching logic supported?

Yes, you can create conditional/branching logic for every step within a survey to ensure participants only complete the applicable steps.

What types of Apple ResearchKit active tasks are supported?

We currently support the majority of Apple’s ResearchKit active tasks. We are continuously updating our library as additional active tasks become available.

Additional features and functionality

Is training required to build a project in MyDataHelps™?

No training is required. The MyDataHelps™ point and click survey designer makes it easy to create a survey within hours with no coding required. Additionally, we maintain a user guide to ensure you have the support you need to build your project.

Can I send messages to participants? Is it possible to send messages to only the participants that match certain criteria?

Yes, you may send push notifications, SMS/text, or emails to participants that match certain criteria including but not limited to recent activity (e.g. adherence, survey answers, enrollment, device usage, surgery date), clinical outcomes (e.g. labs, medications), and participant phenotypes (e.g. age, sex, date of birth).

What are the different ways I can schedule surveys to be delivered to participants?

Surveys can be scheduled for delivery at a variety of times: immediately upon enrollment in the project, relative to a participant event (such as surgery date), on a specific date, or once the participant meets specific criteria. Additionally, you may manually deliver surveys to participants.

What sensor or wearable device and 3rd party application data can participants share with my project via MyDataHelps™?

MyDataHelps™ is able to collect data from the Apple Health, Google Fit, and Fitbit ecosystems, including the devices and 3rd party applications that are supported by these platforms. For example, with Apple Health this includes, but is not limited to, Apple Watch sensor data (heart rate, steps, etc.), blood pressure devices, scales, and sleep apps. With Fitbit it includes wearables and smart scales, including fine-grained intraday data thanks to our partnership with Fitbit. Additionally, MyDataHelps™ can support Apple SensorKit data for approved projects. Please contact us if you are interested in applying for SensorKit for your project.

Does MyDataHelps™ support collecting data from Apple’s Movement Disorder API for participants with an Apple Watch?

Yes, but this functionality is only available for studies involving people with Parkinson’s disease or other movement disorders. Contact us if you are interested in collecting this data for your study.

Is MyDataHelps™ able to integrate participant location data into studies?

Yes, participants can share location data with your study. This is currently available on iOS devices.

Can participants easily share their medical history with my project?

Yes, participants can share their EHR data with MyDataHelps™ through our Connect Provider or Health Plan module. There are currently over 4,000 providers available, and the list continues to grow.

Is historical Medicare data available for participants to share with the project?

Yes, Medicare claims data is available under the CMS Blue Button 2.0 initiative, which includes four years of Medicare Part A, B and D data for 53 million Medicare beneficiaries. This data reveals a variety of information about a beneficiary’s health, including type of Medicare coverage, drug prescriptions, primary care treatment and cost. Blue Button 2.0 uses the HL7 FHIR standard for beneficiary data and the OAuth 2.0 standard for beneficiary authorization.

Does MyDataHelps™ support multi-site/multi-center studies?

Yes. A study can be utilized by researchers from multiple sites and institutions.

Is it possible to import my studies and surveys from other survey design and delivery solutions such as REDCap?

Yes, we support the ability to import your existing surveys and data from REDCap.

Can I customize the participant-facing app?

Yes, you can configure the layout of the participant app by selecting from a library of pre-configured “views” (e.g. Home, Survey Tasks, Device Data) to display within the app. Additionally, you can develop your own custom view or dashboard to display to participants.

Can I incorporate participant rewards within the app?

Yes, MyDataHelps™ can incorporate participant rewards and tracking, for example, assigning points to specific tasks and displaying progress back to the participant. Please contact us for more information if you are interested in incorporating rewards into your project.

Exporting data

How can I access, export, and view the data?

You can set up MyDataHelps™ to automatically export your incremental data on a daily, weekly, or monthly basis. These exports can be downloaded directly from MyDataHelps™ or uploaded directly to your SFTP server or Amazon S3 bucket. Alternatively, you can utilize the Export Explorer feature to query for specific project needs or to connect a data analysis application such as PowerBI, Tableau, RStudio, or Jupyter Notebooks directly to your project’s export database.

What file formats does MyDataHelps™ support for exporting data for analysis?

Data from your study can be easily exported into CSV and JSON format.