Portals

Manufacturer Portal

The Manufacturer Portal is designated for you, the device manufacturer, to use. It provides the following capabilities:

1. The Organizations tab – Allows you to manage the organizations you are working with:

   • Provides statistics and information on every organization as designed in the Portal Builder.
   • Allows adding and removing of organizations.

2. The Devices tab – Allows you to manage the medical devices life cycle from the manufacturing stage all the way to ongoing operations under a specific organization.

   • Create / delete devices.
   • Assign certificates and serial numbers.
   • Assign devices to organizations.
   • Manage certificates, including revocation.
   • Update devices.
   • Configure devices.
   • Collect and view device data and statistics.

Please refer to the articles linked above for additional information about the Manufacturer Portal.

Organization Portal

The Organization Portal's aim is to allow organizations full control over their workflows with the medical device. Starting from the definition of the device and all the way to collaboration with their ecosystem, such as physicians, patients and connecting systems. The Organization Portal is designed via the Portal Builder and can be customized to your specific requirements, as well as the requirements of your organizations.

The Organization Portal provides attribute-based access control that enables definition of different organization users each with a set of permissions. This lets an organization provide access to collaborating entities such as physicians, patients, and medical service providers (for example remote patient monitoring services). The entities can work with the system's capabilities but within the restrictions imposed by the organization. The organization can also restrict data that collaborators are allowed to access, to ensure compliance with HIPAA and GDPR regulations, as well as any internal data policy the organization may have in place. It enables the organization to adhere to both stringent cyber security practices as well as medical governance for privacy, compliance, and PHI protection.

The Organization Portal is built of these different sections:

1. The Patients tab – This is where the users within the organization, who are permitted to do so, can manage patients (add/delete/update). The patient data model for every organization is defined based on the patient template created in the BioT Console.

2. Observations – This view is available after selecting a specific patient and selecting the Observations Tab within a patient's page. It allows users with the right permissions (for example, a doctor with permission to see their own patients) to view patients’ statistics. This tab allows:

   • Viewing Live Measurements - Allows a caregiver to connect to a patient's device to view the current measurements. This includes the Remote Control option which gives caregivers in hospital or clinical settings the ability to turn on a specific device connected to a particular patient and view the patient's measurements in realtime. The Headline shows the numbers for measurements shown in the charts at the current time and the charts show ongoing measurements as they occur.

   • Viewing of historical observations of the patient – A caregiver may want to see a historical view of the patient's medical statistics over time. This tab allows them to open any timeframe in the past and see the different observations for this time frame. Obviously, this can contain a lot of data which is not possible to read so the graphs aggregate data according to the selected time frame and for each aggregated data point it shows the average reading and the standard deviation (as a verticle bar through the average reading). Such a view makes it very easy to read the graph, immediately understanding the overall picture as well as detecting points of interest and anomalies.

3. The Caregivers tab – This is where the different caregivers working with the system are defined by the organization admin. A caregiver is a person who provides medical care to a patient. Caregivers are treated differently from other organization users that do not provide patient care (for example an administrator or a data analyst). From this tab it is possible to manage (view, add, delete, and update) caregivers. It is possible to:

• View a list of all caregivers with data highlights (as defined in the Portal Builder)
• Drill down to every caregiver and receive and edit relevant data (based on permissions control) for the specific caregiver. This is defined in the caregiver template defined by the administrator – different templates can be used for different caregivers.
  From a specific caregiver page, the administrator can manage the caregiver, and view all the patients currently assigned to that caregiver. In specific cases, they can even view medical data for the patients assigned to the caregiver (for example, a head of cardiac surgery who is adding another doctor to their department).

4. The Organization Users tab – This is where the organization administrator can manage all users that are not caregivers. This tab provides a subset of the abilities provided in the caregiver tab. It is possible to manage (view, add, delete, and update) organizational users but it is not possible to assign patients or devices to them. This is done for security and privacy reasons so a complete separation can be maintained between users who do not need to be exposed to sensitive PHI and those who do.

5. The Devices tab – In this view the user can delete/update and manage devices. The organization user (assuming they have the right access permissions) can see the list of devices and information highlights (as defined in the Portal Builder). They can drill down into every device to view relevant information as well as editing information. The user can view all the static characteristics of the device (name, location, firmware date, etc.) and see (if permissions allow) which patient is assigned to the device. Devices may have different characteristics that can be accessed in this tab, and they are directly derived from the device template that was created for it using the BioT Console (see templates section).

For more information on the Organizational Portal including examples and walkthroughs on how to use it, please refer to the articles linked above.