Cures Act Certified Solution
BlueButtonPRO Version 2
HTI-1 Certification
BlueButtonPRO is the nation’s first HTI-1 Certified FHIR API that is offered as a multi-tenant cloud-based architecture positioned as a Software as a Service (SaaS) solution for all stakeholders within the Healthcare continuum. The BlueButtonPRO API provides EHR vendors, payers, hospitals, individual or group providers with an application that satisfies all the mandated requirements for patient data access and more. The API provides compliance with the mandated FHIR v4 standard, the United States Core Data for interoperability (USCDI) v1 as well as, all requirements defined by CMS and ONC in the 21st Century Cures Act interoperability rules.
One key element that BlueButtonPRO addresses is the non-Information Blocking attestation by enabling near real-time information exchange between providers, patients, payers, large health systems and EHRs. Along with the CMS approved patient-facing app, the application places patients in control of their personal and current medical information.
Blue Button® is a government initiative and BlueButtonPRO is not affiliated with or sponsored by Federal Government.
BlueButtonPRO app is approved by Centers for Medicare & Medicaid Services (CMS) for use by Medicare beneficiaries,
Certification Details
HIT Vendor: Darena Solutions LLC
Date Certified: August 7th, 2020
Product and version: BlueButtonPRO Version 2
Certificate Number: 15.04.04.1322.Blue.02.00.0.200807
Modules Tested: 170.315 (b) (10); (d)(1,2, 7, 9, 12,13); (g)(1, 4,5, 7, 10)
This Health IT Module is 2015 Edition Cures compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.
Certified Criteria
Fully compliant with the requirements of HTI-1 EHR Certification BlueButtonPRO offers a certified platform for EHRs to satisfy certification to the following criteria:
170.315 (b)(10): Electronic Health Information Export
170.315(d)(1) – Authentication, Access Control, Authorization
170.315(d)(2) – Auditable Events and Tamper Resistance
170.315(d)(7) – End-User Device Encryption
170.315(d)(9) – Trusted Connection
170.315(d)(12) – Encrypt Authentication Credentials
170.315(d)(13) – Multi-Factor Authentication
170.315(g)(1) – Automated Numerator Recording
170.315(g)(4) – Quality Management System
170.315(g)(5) – Accessibility-Center Design
170.315(g)(7) – Application Access – Patient Selection
170.315(g)(10) – Standardized API for Patient and Population Services
The HTI-1 Certified BlueButtonPRO API allows EHR vendors to expedite the development process to provide an HTI-1 Certified FHIR v 4 API to their end users by interfacing with this pre-certified application.
The features of the certified BlueButtonPRO API are as follows:
Secured using HIPAA-compliant OAuth user authorization
Customizable login and unique patient token creation
Native FHIR v4 data models. No translation is needed to a proprietary API
Delivers XML or JSON via API
Fully scalable to accommodate your growth with no diminished performance rates.
SMART on FHIR compatible for patient access applications, both current and future.
Data Analytics to allow the data to provide actionable outcomes improvement.
User-friendly adapters to allow communication of patient data between multiple EHRs and payers into FHIR data models.
Compatible with the Health IT structured data (ICD-10, RxNorm, SNOMED, etc.) and USCDI data set.
Converts CCDA R2.1 to FHIR resources on demand
Retrieves all or specific classes of patient data (e.g. problems or medications), filtered date, and or a date range
BlueButtonPRO Real World Test Plan and Results
170.315 (b)(10) EHI Export Documentation
BlueButtonPRO supports the export of EHI as follows:
1. FHIR Bulk Export Format: The user can export all available structured data through FHIR APIs as outlined in our swagger documentation. The output format is based on the FHIR Bulk data standard
2. For non-FHIR resources, BlueButtonPRO supports the export as DocumentReference resource types. This resource can be used with any file, including CCDA.
Cost Transparency
| Web-based solution for Patient Engagement (BlueButtonPRO ver. 2) | A contractual agreement for the use of BlueButtonPRO with functionalities outlined in the contract. | (a) BlueButtonPRO is offered as a SAAS model. (b) One-time implementation fee may apply for functionalities outlined in the contract. (c) Pricing options are based on a combination of per provider and/or per patient. (d) An extended service plan fee might apply. (e) Additional hosting charges might apply. |
| 170.315 (b)(10): Electronic Health Information Export | Enable a user to timely create an export file(s) with all of a single patient’s electronic health information stored at the time of certification by the product, of which the Health IT Module is a part. | Included in the contract. No additional costs or fees. |
| 170.315 (d)(1): Authentication, Access Control, Authorization | Authenticate user and establishes permitted user access | Included in the contract.No additional costs or fees. |
| 170.315 (d)(2): Auditable Events and Tamper Resistance | Record actions related to electronic health information. Audit log records the audit log status and/or the encryption status. For all permissible actions, the audit log function records the following data: Date and Time, Patient Identification, User Identification, Type of Action, and identification of patient data accessed | Included in the contract. No additional costs or fees. |
| 170.315 (d)(7): End-User Device Encryption | Electronic health information is NOT locally stored on the end-user’s device | Included in the contract. No additional costs or fees. |
| 170.315 (d)(9): Trusted Connection | Health IT product implements Transport-Level security: Establishing a trusted connection in accordance with the standards specified at §170.210(a)(2) and §170.210(c)(2) | Included in the contract. No additional costs or fees. |
| 170.315 (d)(12): Encrypt Authenticate Credentials | BlueButtonPRO encrypts stored authentication credentials in accordance with standards adopted in 170.210(a)(2) | Included in the contract. No additional costs or fees. |
| 170.315 (d)(13): Multi-Factor Authentication | BlueButtonPRO does not employ Two-Factor Authentication | Included in the contract. No additional costs or fees. |
| 170.315 (g)(1): Automated Numerator Recording | BlueButtonPRO will provide the patient's name and date of data query | Included in the contract. No additional costs or fees. |
| 170.315 (g)(4): Quality Management System | The use of a Quality Management System (QMS) must be identified in the development, testing, implementation, and maintenance for each capability | Included in the contract. No additional costs or fees. |
| 170.315 (g)(5): Accessibility-Centered Design | Identify accessibility-centered design is deferred for each capability of the product | Included in the contract.No additional costs or fees. |
| 170.315 (g)(7,10): Application Access - Patient Selection, All Data Request and Standardized API for Patient and Population Services | Access to query the system via API by either patient or clinical uses. | Included in the contract. No additional costs or fees. |
* Costs or Fees: Types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the implementation or use of the capability -OR- in connection with the data generated in the course using the capability.