Frequently Asked Questions
- How much experience with programming and/or database knowledge is required to use MyDataHelps Designer?
No programming or database experience is needed to use MyDataHelps. The point and click study builder within MyDataHelps Designer is all you need to create your studies and surveys.
- How do participants complete surveys and interact with a study?
Participants complete surveys, active tasks, and manage device data directly on the mobile (iOS and Android) MyDataHelps app. In addition, participants can use the web to complete surveys, although active tasks (e.g., two finger tapping, memory test) and electronic consent functionality are not currently supported on the web.
- How does MyDataHelps participant app increase participant adherence?
Participants find it more convenient to complete surveys on their phone compared to the traditional research method of scheduling and completing a phone call with a study administrator or visiting a clinic. Additionally, participants can be reminded periodically via a push notification to complete any outstanding surveys. You may nudge participants by sending targeted messages to only those that meet certain criteria.
- Will I be able to change my research study after I start inviting participants?
Yes, you can continually update survey instruments, modify schedules, and deliver tasks during the course of a study.
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?
Account and Billing Account and Billing
- What does the free account include? How many participants can I add with this free product? Is there a time limit?
You may currently create a free account and utilize all MyDataHelps functionality to send your study to up to 100 participants. 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 organization administrator add you as a user, after you register and create your individual MyDataHelps account. You will then be able to create a new study within the existing organization and utilize the surveys and settings already created. If you intend to create a different study with a different set of surveys, you will need to create a second organization.
Consent Forms and Electronic Signatures
- How do participants sign a study consent form before joining a research study?
Before joining a study in the MyDataHelps app, participants are prompted to complete the electronic consent form and provide their electronic signature.
- 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? What type of answer formats are supported?
Currently, MyDataHelps surveys include but are not limited to the following question or step types: instruction, question, form (multiple questions within one step), image capture, video capture, completion step, and countdown step. 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 answers 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?
- 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
- How much training is required to build a study in MyDataHelps?
No training is required. The MyDataHelps point and click WYSIWYG 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 study.
- Can I send messages to participants? Is it possible to send messages to only the participants that match certain criteria?
Yes, this is possible utilizing our advanced rules engine. 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?
You may set a schedule to deliver surveys to participants anchored on enrollment, participant event (such as surgery or discharge), or a specific date. You may choose to deliver a survey on a set frequency anchored on that date (e.g. deliver a survey every two days, starting one week after enrollment). Additionally, you may manually deliver surveys to participants.
- Can I schedule surveys to be delivered relative to some custom anchor date such as date of surgery or date of discharge?
Yes, you can set a custom date as a reference point to deliver surveys to participants.
- What sensor or wearable device and 3rd party application data can participants share with my study 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.
- 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 the MyDataHelps support team if you are interested 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 study?
Yes, through MyDataHelps the participant can download their medical history data from supported systems that comply with the SMART on FHIR standards. Hundreds of providers across the United States currently support this standard, including major health systems like Cedars-Sinai, Cleveland Clinic, and Geisinger.
- Is historical Medicare data available for participant’s to import into a study?
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.
- What file formats does MyDataHelps support for exporting data for analysis?
Data from your study can be easily exported into CSV and JSON format.
- How often can I export my data?
You can set up MyDataHelps to automatically export your incremental data on a daily, weekly, or monthly schedule.
- Can I export my study data manually?
Yes, this is possible by working with an MyDataHelps team support member. To ensure your have your data on demand, it is recommended that you set an automatic export frequency before going live with your study.
- How do I export and view study data?
MyDataHelps allows you to set a daily, weekly, or monthly frequency to export your incremental study data.
- Can I use an SFTP server to export?
Yes. In addition to or as an alternative to setting an automatic export frequency, you may set the MyDataHelps settings to export your data directly to an SFTP (SSH file transfer protocol) server site.