Complete Patient & Device Remote Monitoring and Control
The RxPense® Portal is an integral part of the RxPense® ecosystem. It provides secure, cloud-based access to patient profiles and the administration of RxPense® Hubs, regardless of location. The cloud securely hosts our Web Portal and API Component which bridges the RxPense® with Caregivers, Patients, Physicians and Pharmacists. The Portal fully supports Medipense concept of the Home Health Hub by providing access to data and monitoring, 24×7.
Role-based access and Management
There are 3 primary roles defined within the RxPense: Organization, Caregiver and Patient.
An Organization Admin is a high level user which manages all the RxPense® devices allocated to a particular organization. There may be several sub-organizations and thousands of devices. A hospital, managed care facility, heath care insurer, payor or seniors residence are typical organizations.
A Caregiver gives care to the person with whom they are entrusted. Typical examples include a son or daughter caring for their mother, a wife cares for her husband. There are also nurses, paid caregivers and others.
A Patient is the person under care, the consumer of the medications securely locked in the RxPense.
Brief descriptions of their roles and permissions are provided below.
Patients register on the RxPense® Hub or via the Portal with their favorite tablet or personal computer online and can have full access to their medication history and other details provided by their physicians and pharmacists. Patients may add information pertinent to their care at any time.
There are literally hundreds of permissions set throughout the RxPense® ecosystem, managed securely in the cloud. Each user is assigned a specific role. Each role has limited access. Authentication at all levels is required and data is encrypted. HIPAA and PIPEDA and PHIPA are part of our DNA.
Full Audit Trail
Complete capture and secure storage of events and activities in the audit trail. Images of medications in the device being dispensed along with operational, access, survey and consumption data are securely stored in the cloud for remote monitoring, reporting and analysis.
Organization Admin Role
An Organization Admin is a high level user which manages all the RxPense® devices allocated to a particular organization. There may be several sub-organizations and thousands of devices. The Organization Admin is presented with a consolidated view of all the data from within their network.
Organization Admins interact with the Portal to perform common tasks like:
- Add Sub-Organization (ward, department, sub-department, client, etc.)
- Invite Organization admin
- Invite Device Admin
- Invite Delivery Technician
- Assign Device to Delivery Technician
- Invite HCP
- Invite Patient
- Assign Device to Patient
- Add NFC Tag, assign to User
- View Subscription
- Select Organization default / required Firmware version
- Block User from system
- Block NFC Tag from system
- Generate and View Reports
- Edit own profile
Every user must be authenticated; not all users have access to all functions.
Caregivers, give care to the person with whom they are entrusted. Typical examples include a son or daughter caring for their mother, a wife cares for her husband. There are also nurses, paid caregivers and others that fulfill the role of caregiver – ensuring the well being and care of the patient. They can handle household chores, prepare meals, manage medications and even speak to doctors and nurses on behalf of those that they care for.
Caregivers interact with the Portal to perform everyday tasks like:
- View Caring For, add Medical Condition, add Allergy, add Prescription, request Refill
- Edit own profile
- Invite/Add Patient
- Voice / video call Patient
Every caregiver must be authenticated; not all caregivers have access to all functions. Depending on the health and status of the patient, caregiver or physician permissions may be required to access the patient portal.
The patient role is designated to the person under care. The senior, chronic care patient or other person whose medications are stored and released, at the right time, by the RxPense® Hub.
Patients interact with the Portal to perform everyday tasks like:
- Adding an OTC or other medication
- Recording medical conditions, vitals and history
- Adding an event or appointment
- Editing own profile
- Responding to a health survey
- Inviting a HCP, family member, friend, etc. to Circle of Care
Every patient must be authenticated; not all patients have access to all functions. Depending on the health and status of the patient, caregiver or physician permissions may be required to access the patient portal.
In addition to monitoring and administering capabilities, the RxPense portal can deliver custom-configured surveys to the RxPense Hub. Before or After dispensing the medications, patients can be asked simple or more advanced questions about their well-being, health or consumption habits.
Administrators set up the survey online in the portal, to be delivered at specific times, to 1 or many patients. Data collected may be stored with the patient profile or anonymized for further, confidential analysis and processing.
Surveys are displayed to the patient on the RxPense Hub screen and patients may respond by tapping the appropriate answer or using their voice to indicate their choice.
Surveys may be a simple as a single yes/no question or as complex as ratings and conditional display logic conditions. Consolidated reports are available to the administrator with a simple click.
FDA 21 CFR Part 11 Compliance
21 CFR Part 11 regulations set forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
The software development methodology and quality system that is in place at Medipense along with the functionalities of the cloud-based software have been reviewed for ability to comply with FDA 21 CFR part 11. The conclusion is that the software is part 11 ready and if configured properly by the client will meet 21 CFR part 11 expectations for compliance.