•Clinic Administrator (ability to create and edit clinic user accounts)
•Patient Administrator (ability to create and edit patient records)
•Device Manager (ability to create and edit Device Settings)
•Clinic Settings Manager (ability to create and edit device settings templates and clinic flag rules)
•Basic Clinic Access (ability to view patient information including treatment information and device settings).
A Sharesource user must be assigned at least one role, but may be assigned up to all 5 roles.
Critical Design Elements
The SHARESOURCE platform is built with multiple design considerations and supports software design best practices such as disaster recovery, scalability to meet the growing demand, logging, monitoring, auditing, role-based access control, multi-factor authentication, data privacy, and security.
Fig. 3. Treatment summary run sheet and cycle profile example for a patient with an AMIA cycler.
Security is a primary design requirement for Sharesource. The SHARESOURCE platform supports and meets various industry standards and implements security at various levels such as application, device communication, network, and infrastructure.
At an application level, all clinicians are required to have a login and password to access the SHARESOURCE Clinical Portal. While setting up the account, clinicians need to meet strict password requirements and are required to setup security questions. Clinics which have stricter security needs can opt for a second level authentication such as one time token or SMS (short message service). Clinicians are required to change their password at regular intervals. These activities are recorded and stored in an encrypted data store for future audit and compliance needs.
Table 1. Features available in SHARESOURCE clinical portal
All communications between the cycler, remote connectivity server, and Sharesource are encrypted with industry standard protocol (128 bit SSL/HTTPS). An additional level of security is implemented directly between the cycler and Sharesource, all data (treatment files and device settings) exchanged between the cycler and the SHARESOURCE platform is encrypted with a highly secured encryption algorithm. The remote connectivity server cannot read these data packets, and it acts as a postman delivering the packets without accessing the contents.
Sharesource Features
The majority of Sharesource features and functionalities can be divided into 2 pieces: remote connectivity and device communication, which is transparent to clinicians; and the SHARESOURCE Clinical Portal which provides an intuitive and user friendly interface for the clinicians.
Remote Connectivity and Device Communication
The SHARESOURCE Medical Device Connectivity platform uses a remote connectivity server to bridge the communication between the cyclers and Sharesource. Clinicians can create and edit Device Settings using Sharesource which is transmitted to the cycler upon request. The patient uses an activation code that is provided by their clinician to initially connect and communicate with Sharesource. At defined intervals, the cycler will check for device settings updates. However, once a patient starts the treatment, the cycler blocks all inbound and outbound communication for the duration of therapy. This removes any possibility of external updates to the data during the therapy. Once the treatment is completed, the cycler transfers the treatment file to Sharesource.
SHARESOURCE Clinical Portal
SHARESOURCE Clinical Portal provides a user-friendly interface with intuitive navigation supporting the clinicians and specifically aligned to their expected day-to-day activities within a clinic. It offers a variety of features and data views controlled by the clinician’s Sharesource user role (Table 1).
Sharesource Workflow
When a clinic decides to use the SHARESOURCE platform for remote patient management, a Sharesource administrator will determine which region the clinic is to be associated and creates a Sharesource clinic in that region. As part of that process, the Sharesource administrator will create a clinic administrator user and identify which Sharesource products the clinic will have access to (Fig. 4).
The clinic administrator will create user accounts for the clinic staff that require access to Sharesource. The created user accounts will identify what Sharesource role(s) each user will have. At least one clinic user will have the patient administrator role with the ability to manage patient records for the clinic. The patient administrator(s) will create a patient record for each of the clinic’s patients that will use an AMIA, HOMECHOICE CLARIA or KAGUYA cycler that will be remotely managed through Sharesource.
If clinic-wide device settings templates or flag rules are to be used, at least one clinic user will have the Clinic Settings Manager role assigned to them and be responsible for their setup. Flag rules can be created and adjusted at any time. The changes will be applied the next time the event flags are evaluated for display.
The clinician who manages the patient’s therapy will have the Device Manager role and will create the Device Settings for the patient within Sharesource. This includes identifying the survey questions that the clinician requests the patient to respond to, which will be used to aid in the monitoring of the patient’s status. Once the patient is trained and ready to go home, the clinician will provide the patient activation code (PAC) to the patient. The PAC is a global unique identifier that the patient will be prompted to provide the first time they interact with their cycler. The cycler will communicate with Sharesource to provide the PAC and request the Device Settings for the patient. When Sharesource responds to the cycler, it will provide additional patient information so the cycler can ask the patient to confirm their identity. Upon confirmation, the Device Settings are presented to the patient for review and acceptance. Once the patient accepts the Device Settings, the cycler is available to provide the programmed therapy.
Fig. 4. High-level workflow view.
When the patient is ready, they set up the cycler with their disposable set and solutions, connect to the cycler, and perform their treatment. The cycler does not communicate with Sharesource during the treatment, so real-time monitoring of the patient’s treatment is not available. The patient’s cycler will communicate with Sharesource when the treatment is complete to securely send the treatment information details. When Sharesource receives a treatment file from a patient’s cycler, it is confirmed to be valid, and the patient and clinic are identified from the information. As the information is being processed, it is evaluated against the flag rules criteria and the result stored in the patient’s record.
The patient’s record is available for the clinician to view at a summary level on the Treatment Dashboard. The use of Patient Event icons can help the clinician to prioritize the review of the patient’s more detailed treatment information compared to those that report a condition or event that the clinician has indicated that they want to be notified of. Patients who have a status of “no treatment” or “no communication” may also be a priority for clinician review. These 2 status provide the clinician with a view