PULSE Clinic Program

The PULSE teams works directly with Alberta Health Services (AHS) and the University of Calgary to manage all patient information. We adhere to the highest standards in data protection, security and confidentiality surrounding both the access and management of personally identifiable and/or protected health information.

When a patient completes a questionnaire, all responses are stored on a secure University of Calgary research server that only designated PULSE Team members can access. 

In Alberta, patient health data is protected under the Personal Information Protection Act (PIPA). To comply with this regulation, and to achieve matched compliance with international health information protection acts including HIPAA  and GDPR, the PULSE Program uses a comprehensive de-identification process that manages all electronic health information, transforming these into non-identifiable data products. 

It is only upon thorough review by AHS data analysts that any patient data resource can be made available to researchers.

Alberta Health Services and the University of Calgary are ultimately responsible to govern programs, like the PULSE Program, that access and use patient health information to ensure the highest standards of data privacy and protection are in place and are being maintained. 

The PULSE Program is subject to all the rules and reviews of both institutions and remains committed to upholding the highest standards of data privacy and protection.

Patient registration, consent, and questionnaires are administered using REDCap. REDCap (Research Electronic Data Capture) is a secure web application designed for building and managing online questionnaires. It is the most commonly used platform in research studies globally and is fully supported and managed by the University of Calgary.

The PULSE Clinic Program relies on combining two primary sources of data to develop predictions regarding current or future health:

1. Health questionnaires – we use electronic questionnaires to gather information from patients regarding important aspects of their life and health, including symptoms, quality of life, and lifestyle factors. 
2. Electronic Health Records – with permission, we securely access relevant information from the AHS electronic health record. This includes data such as laboratory results, medications, and diagnostic test results, like ECGs, echocardiograms, angiograms, cardiac CT, MRI, and nuclear medicine.

When you submit your questionnaire and indicate your permission to link to your health record, your health number is used by a designated Senior AHS Data Analyst to access the relevant electronic health data approved by the Research Ethics Board and by Alberta Health Services for the PULSE Clinic Program. This data is then de-identified and linked to your questionnaire responses using a unique identifier. This combined and de-identified data is then migrated to a secure data server for research access.

Identifiable data refers to any information that can be used to identify an individual, either directly (like names or health care numbers) or indirectly (like birth dates).

De-identifying data means removing or altering identifiable information so that individuals cannot be easily recognized. This process can involve techniques like:

1. Anonymization: Completely removing identifiable details.
2. Pseudonymization: Replacing identifiable information with pseudonyms, allowing for some level of tracking without revealing identities.

De-identification helps protect privacy while still allowing for data analysis and research.

All PULSE Program research data is de-identified and stored following pseudonymization to a secure research server. Anonymization is achieved by removing all information that can identify a patient followed by assigning a randomly generated, 24-character alpha-numeric universally unique identifier (UUID). 

This identifier can only be de-coded by AHS staff to reveal a patient's identity using a master "decoding list" maintained and stored on a separate, encrypted, and password protected server. Only authorized study personnel will be granted access to data files that contain identifiable information.

Once data has been de-identified, researchers are able to work with the data without risk of identifying who the data originally belonged to. 

There are three main uses for the data the PULSE Clinic Program collects:

1. Personal health summaries: When a patient in the PULSE Clinic Program completes a questionnaire, our system combines this information with previously collected data to create a summary of current health. This summary is provided directly to the patient and is not shared with anyone else unless the patient requests. Patients can choose to share their report with care providers to assist in making care decisions at time of clinic appointments. However, the patient is in complete control of when and who they share this information with. 
2. Cardiovascular research: The Libin Cardiovascular Institute is a leading academic institution that performs research across many aspects of cardiovascular health. The data collected by the PULSE Clinic Program can assist researchers from across the Institute to better understand how disease affects patients, and how they respond to care decisions. Researchers who obtain appropriate ethics and data use approvals from the University of Calgary and Alberta Health Services may submit requests to access de-identified data from the PULSE Clinic Program to advance personalized cardiovascular care. This data usage is monitored by a steering committee.
3. Personalized Care and Clinical Decision Support Tools: The data collected by the PULSE Clinic Program is aimed toward supporting the development of personalized clinical decision-support tools. These tools will be tested in-clinic on an opt-in basis. This means that, like the PULSE Clinic Program, consent will be sought from patients before personalized clinical decision-support tools are used. In addition, oversight and safety monitoring will be provided by research ethics boards during testing.

Personalized care (often referred to as personalized medicine or personalized healthcare) is an approach to healthcare that tailors treatment decisions to an individual patient’s characteristics, preferences and needs. It moves away from the traditional "one-size-fits-all" approach to provide more effective, customized care that considers each patient's unique combination of disease characteristics, life circumstances and personal experiences.

The vast information collected by today’s electronic health systems has the potential to deliver far more advanced care for patients. However, core information allowing us to understand how this data takes on different meanings from one person to another is often missing. For example, our background and lifestyles can affect how we develop disease and respond to care. Therefore, to develop personalized care we need to develop a consistent understanding of who the patient is from their own experience.

By combining questionnaires that are carefully designed to capture personal characteristics and experiences with electronic health information, we can develop care models that are tailored to meet the needs of individual patients. Initiatives like the PULSE Clinic Program are a critical step toward enabling personalized care for Albertans. 

The first step of the PULSE Clinic Program is to establish a deep understanding of our patient population across each of the clinics. This is a critical step to ensure that all tools developed recognize the diversity of our population and their needs. Teams from across the Libin Cardiovascular Institute will then be provided support to develop, validate, and test the implementation of targeted clinical decision support (CDS) tools that are aimed at improving care decisions and patient health. It is expected that personalized CDS tools will be made available for testing in target patient groups as early as 2027.

No, research teams can submit data requests to the Libin Precision Medicine Initiative. Anonymized data can be released for Ethics Review Board and Alberta Health Services approved projects. Anonymized data is only provided in accordance with formal data-sharing agreements with the University of Calgary and Alberta Health Services that contractually bind specific data use on a project-by-project basis. 

Yes. Patients always remain in complete control of their ongoing participation in the program and the ability for their previously collected data to be used. If you have joined the PULSE Clinic Program and would like to change your participation status, please visit the following link: www.PulseClinicProgram.ca/withdraw.