HDVA Platform

HDVA Delivery Operations
HDVA Delivery Operations is responsible for ensuring that NHSi routinely meets orexceeds the promises made to its customers concerning the clinical, scientific, and economic value of HDVA technology. HDVA Delivery Operations encompass three components:

  1. Building, operating and continually improving the HDVA delivery platform consisting of instrumentation to acquire blood flow data, and the HDVA software platform to automatically calculate and deliver accurate test results to clinical reading centers;
  2. Building and maintaining the HDVA database to support the on-going discovery and development of new HDVA applications. This includes setting and enforcing standards to ensure that every data point in the HDVA database meets NHSi standards for data integrity; and
  3. Creating and delivering HDVA delivery services through a separate clinical entity that include the training, technical and clinical support needed to ensure that customers are consistently able to make the best use of HDVA in their field of activity.

All three functions are designed toscale cost effectively to the high end of the range ofexpected demand for HDVA and to comply with all service standards of NHSi and regulatory requirements.

HDVA Delivery Platform
The HDVA delivery platform will consist of three key components:

  1. Doppler instrumentation that captures patient blood flow data and transmits that data to the Software Platform for analysis by HDVA;
  2. The HDVA software platform that automatically analyzes blood flow data generates the report from the HDVA distributes the report to the clinical customer through a separate clinical entity, the reading center; and
  3. The HDVA reading and support center that provides the HDVA report, HDVA-related medical consultations to customers of HDVA and disseminates HDVA-related medical education content to customer and the broader medical community.

Doppler Instrumentation
 Doppler instruments are FDA-cleared devices used to capture blood flow data. These instruments are manufactured and distributed by a number of companies and are either currently compatible with HDVA or easily made so. NHSi intends to offer HDVA to users of any FDA-approved TCD device.

HDVA Software Platform
NHSi has developed a HDVA Software Platform to automate data collection, data analysis, HDVA report generation and delivery, and customer billing.

The current HDVA software platform has been designed on a centralized processing architecture that provides for efficient software maintenance and support and requires only an industry standard internet browser and an internet connection on the customers’ computer. The centralized processing model was designed to enable NHSi to ensure quality of service and offer HDVA to the users of any instrument approved by the FDA.

HDVA Reading Centers

Pre-Approval from the FDA
Until NHSi receives clearance for HDVA, NHSi physicians will use HDVA in their medical practices and provide consultation reports based on HDVA principles to the referring physician (the physician who referred the patient for a HDVA-enabled TCD test).

Post-Approval from the FDA
Following receipt of FDA clearance for HDVA, review by NHSi physicians and approval of the HDVA report prior to distribution will no longer be mandatory. However, NHSi anticipates continuing customer demand for access to certified specialists of HDVA. NHSi will enter into affiliation agreements with multiple regional reading centers to provide over-read services, consultations and education and support services for an additional fee.

General
All readers must meet the licensure requirements of the applicable jurisdiction in which the patient seeks treatment.  In some jurisdictions, this may require readers to be licensed in those states in which the patients reside.  In addition, some jurisdictions prevent non-licensed persons, including NHSi, from engaging in activities that could be construed as the practice of medicine or another healing art.  Accordingly, in such jurisdictions, NHSi may not be permitted to provide HDVA services directly and may need to enter into one or more arrangements with appropriately licensed providers to render HDVA services.  We are in the process of assessing the extent to which our activities implicate these requirements, and may be required to adjust our business plan to comply with such requirements.

HDVA Delivery Services
Clinical affiliates of NHSi offer the following HDVA delivery services in addition to the HDVA report:

  1. Medical consultations supporting the use of HDVA in clinical medicine;
  2. Medical education enabling the adoption of HDVA in clinical medicine; and
  3. HDVA technical services supporting adoption of HDVA in commercial, academic and government research institutions.

HDVA Reports in Clinical Medicine
Clinical HDVA report delivery involves distributing a comprehensive, accurate HDVA report to the requesting customer within the agreed-upon turn-around time.  Standard turn-around times will be 36 hours for a standard HDVA report and eight hours for a STAT HDVA report.

Clinical Medicine Consultation
Clinical Medicine Consultations are comprised of:

  1. Over-read of the HDVA report as described above; and
  2. Timely, clear responses to follow-up questions regarding a HDVA report or relating to the use of HDVA in complex medical cases.

Medical Education
Medical education will involve the distribution of HDVA-related medical content designed to assist the medical community with the initial adoption of HDVA and the on-going adoption of new applications for HDVA.

Medical education will be delivered through a combination of on-line resources available on the NHSi web site, classroom training offered in conjunction with academic institutions, and an on-line peer-reviewed medical journal sponsored by NHSi.

HDVA Technical Services - Research
NHSi scientists consult with research institutions regarding the application of HDVA in research trials. NHSi will also provide data analysis and compilation in support of research trials utilizing HDVA.

HDVA Database
NHSi will capture all of the data from each HDVA performed and store that data in a de-identified format in a HDVA reference database. The reference database will be the primary resource used continuously to improve the granularity of the HDVA reference statistics, support new research and development activities, and discover and commercialize new applications for HDVA.

Various federal and state laws, including without limitation the federal Health Insurance Portability and Accountability Act of 1996, impose obligations on certain entities to safeguard the privacy and security of individually identifiable health information.  These laws may affect the manner in which we, our customers and our affiliates use and disclose such information, and we may need to change our business operations to comply with these laws.  HDVA Delivery Operations will establish and enforce applicable standards for privacy, data security and authenticity to ensure compliance with these standards and the on-going and increasing value of the Database for HDVA.