TITLE 1.ADMINISTRATION

Part 18. TELECOMMUNICATIONS INFRASTRUCTURE FUND BOARD

Chapter 471. OPERATING RULES OF THE TELECOMMUNICATIONS INFRASTRUCTURE FUND BOARD

The Telecommunications Infrastructure Fund Board (TIFB) proposes new §471.55, concerning Minimum Standards for the Provision of Telemedicine Medical Services. The new section is required by S.B. 789, 77th Leg., R.S.(2001) and was developed in conjunction with the Health and Human Services Commission (HHSC). The proposed provisions will establish a joint rule of the two agencies.

Dirk Jameson, Executive Director, has determined that for the first five-year period the rule is in effect, there will be no fiscal implications for state or local governments as a result of enforcing or administering the rule.

Mr. Jameson has also determined that for each year of the first five-year period the rule is in effect, the public benefit anticipated as a result of enforcing the new rule will be that the citizens of Texas will benefit from technologically performing, interoperable, private, and secure systems at Medicaid participating clinics using telemedicine devices. There will be no effect on small businesses. There are no anticipated economic costs to persons who are required to comply with the rule as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Dirk Jameson, Executive Director, 1000 Red River, Ste. E208, Austin, Texas 78701, or by electronic mail to djameson@tifb.state.tx.us. Comments will be accepted for 30 days after publication in the Texas Register .

The new section is proposed under §57.045(d)(2) of the Texas Utilities Code, which provides the TIFB with the authority to promulgate rules to reasonably affect the purposes of this chapter. The new section is also proposed under the Government Code, §531.02161. The TIFB interprets this section to require the TIFB and HHSC to adopt joint rules establishing and adopting minimum standards for an operating system used in the provision of telemedicine medical services by a health care facility participating in the state Medicaid program, including standards for electronic transmission, software, and hardware.

No other statutes, articles, or codes are affected by the proposed new rule.

§471.55.Minimum Standards for the Provision of Telemedicine Medical Services.

(a) Purpose. This section outlines the minimum standards for an operating system used in the provision of telemedicine services by a health care facility participating in the state Medicaid program, including standards for electronic transmission, software, and hardware. These standards were developed in conjunction with the Health and Human Services Commission. The proposed provisions will establish a joint rule of the two agencies. The minimum standards are intended to ensure, as much as it is possible, the continuous and long-term use of telemedicine equipment in a changing medical and technological environment. The key issues are to develop interoperability, compatibility, scalability, accessibility, and reliability with future systems. The standards also address minimum security standards which ensure the integrity, privacy, and/or safekeeping of data in normal use of telemedicine technology. Where there is a question regarding security standards, refer to the Department of Information Resources, "Practices for Protecting Information Resources Assets."

(b) Definition of "telemedicine." Section 57.042 of the Texas Utilities Code defines telemedicine and states:

(1) Telemedicine means medical services delivered by telecommunications technologies to rural or under served public not-for-profit health care facilities or primary health care facilities in collaboration with an academic health center and an associated teaching hospital or tertiary center or with another public not-for-profit health care facility; and

(2) Telemedicine includes consultive services, diagnostic services, interactive video consultation, teleradiology, telepathology, and distance education for working health care professionals.

(c) Scope. The scope of these standards includes equipment, assets, practices, and technologies used in telemedicine medical services by a health care facility participating in the state Medicaid program, including standards for electronic transmission, software, and hardware.

(d) Technical Standards. Whenever possible, implementations shall adhere to industry- standard technologies and/or practices, and all components shall be Y2K compatible. The minimum technical standards for a telemedicine application or system follow.

(1) Workstations.

(A) Operating systems shall be current off-the-shelf operating systems, capable of being upgraded as new versions become available;

(B) Software must be properly licensed with suitable maintenance contract signed;

(C) A three-year warranty shall protect equipment. The manufacturer or vendor must be able to support the system architecture throughout the warranty period, including repair parts;

(D) Processors shall be from Intel, Motorola, AMD, IBM, or other manufacturers of compatible equipment. Processing speeds and other processor-related specifications shall be sufficient to accommodate the operating system and the application for a trouble-free telemedical practice;

(E) Memory shall be of sufficient quantity to run the operating system and application. Boards shall have physical and logical room to accommodate incremental upgrades;

(F) Network adapter shall be of appropriate speed and characteristic to address compatibility, latency, and quality of service issues; and

(G) After installation of the operating systems, drivers, and applications, each workstation shall have sufficient storage space remaining in order to allow room for actual usage. Access speeds shall be sufficient to accommodate compatibility, latency, and quality of service issues.

(2) Servers.

(A) The servers may be single or multi-processor capable, shall have a three-year warranty, and shall be compatible with operating system and application;

(B) Servers shall provide sufficient online time for session data to be saved and the server to be powered down properly; and

(3) Network and Transmission.

(A) All transmissions will be of sufficient speed for the intended application;

(B) Transmission media and systems shall be of any kind that provides sufficient range, speed, security, and error-correction to maintain performance, data integrity, and privacy. Switches, hubs, routers, and access points shall be placed in a secure location. Installations and terminations must conform to building standards and all applicable state and local codes, and be conducted by a trained, certified technician; and

(4) Video Conferencing System.

(A) In general, video conferencing shall permit appropriate resolution, quality of service, and latency for the purpose intended. Fully integrated set top or room systems shall have sufficient throughput for medical communication and/or diagnostics. For multipoint conferencing, 384 Kbps is an acceptable minimum. For specific standards based on bandwidth capacity, see Appendix;

(B) Connectivity shall include LAN, WAN, plain analog telephone service, remote access service, and/or internet capability;

(C) The video conferencing system shall communicate using H.323 and/or H.324 protocols. The system must provide interactive two-way video with two-way audio and two-way data. All video conferencing equipment proposed must support International Telecommunications Union-Telecommunications (ITU-T) recommendations. Any system connecting to an H.323 network is required to provide its own H.323 compliant data output and/or conversion ability. For legacy systems, this could be accomplished by the addition of a protocol converter, gateway, or other device;

(D) Gateway and protocol converter shall be of sufficient speed, robustness, compatibility, and accuracy to provide protocol processing services necessary for the telemedicine implementation;

(E) The video conferencing system must have a transmitted picture frame rate suitable for the intended application, and must be capable of 30 frames per second at 384 Kbps. All applicable equipment shall be UL and FCC Class A approved;

(F) Installation technicians shall have training conducted by the manufacturer and installations shall be made in accordance with manufacturers' practices and guidelines;

(G) System acceptance testing shall be done within 30 days of installation, subject to network availability. At a minimum, these tests shall include:

(i) video performance with minimal fades, dropouts, cyclical dropouts, or noise;

(ii) correct operation of the video terminal equipment;

(iii) correct operation of PC equipment; and

(iv) capability of 30 frames per second at 384 Kbps.

(H) Warranty shall be in effect for three years from the date of acceptance for all hardware and software, with next business day shipment for hardware replacement. At a minimum, all equipment shall be warranted against defects or failure of design, materials, and workmanship. Defective equipment shall be repaired or replaced at no cost to the telemedicine facility. The warranty shall cover any costs to bring the equipment to full function such as labor and shipping and handling charges. The vendor will note any days, times, and holidays when their personnel will not be available to take or process warranty-related inquiries. The telemedicine facility shall be provided with a toll-free telephone number, and an electronic mail address to use to report non-functioning equipment subject to the warranty coverage. Equipment warranty repair will be completed on a remove and replace basis, where the equipment will be restored to full functionality within a minimum time. Defective equipment that must be replaced, shall be replaced with new or like-new equipment; and

(I) Technical support shall begin on the date of acceptance through the three-year warranty period. Technical support shall be available on all equipment hardware and software, by either toll-free telephone number, online, or both. The vendor shall note any hours, days, or holidays when technical support calls will not be taken.

(5) Additional Equipment, Software, and Services.

(A) Printers shall be of sufficient resolution and speed, and shall accommodate required paper sizes and types;

(B) Scanners, digital cameras, video camcorders, video capture cards, and other image capturing devices shall be capable of treating digital images at a sufficient size, resolution, compression, data integrity, speed, media, media handling, and/or color to meet the application requirements;

(C) Software shall provide sufficient compatibility, capability, performance, security, management, and/or communication services necessary to apply or support the telemedicine implementation. It shall be capable of being upgraded, and fully licensed to the operating entity;

(D) Still image capture/store and forward, and streaming video equipment, in regard to digital content of both transmission methods, shall be of sufficient size, resolution, clarity, color, and quality of service, for both audio and video, to perform a medical evaluation, assessment, or medical consultation. Still image capture/store and forward refers to the ability to capture or record images, scanned documents, and clinical notes, which are then transmitted at a later time. Video streaming usually refers to real time video transmission or examination session.

(E) All other equipment, components, and/or services not listed specifically, but used in conjunction with telemedicine implementations, shall support the performance of the implementation; and

(F) Medical equipment used in conjunction with telemedicine must meet 510K federal certification. Examples of medical equipment include: spirometers, X-ray, digital X-ray scanners, ultrasound machines, examination cameras, ophthalmoscope, fundus scope, diagnostic printers, and stethoscope.

(6) Exceptions. Implementations which fall below or outside of the aforementioned technical standards must, nevertheless, be able to demonstrate the long-term effectiveness and sustainability of the specific telemedicine implementation. Such implementations shall still comply with the Technical Practices Requirements described in Section 471.55(7) below, and state and federal law.

(7) Technical Practices Standards. Technical implementations shall support security, privacy, integrity, authentication, and business continuity practices as applied to telemedicine activities as follows:

(A) All access to data and transmission thereof must require unique user identification and verification ensured by the system. Technology shall support the authentication of users and provide logs to prove such authentication;

(B) Data shall be verifiable as to its origin. Technologies and business practices shall work together to ensure that genuine, authenticated data is transmitted through the network and is identifiable as such to the users;

(C) Equipment shall be sufficiently physically safeguarded to prevent unauthorized access. This includes: keyboard, monitor, input devices including any monitoring and diagnostic instruments, data storage components, cable rooms, and servers. Institutional management shall use appropriate technologies and business practices to ensure controlled access;

(D) Telemedicine equipment and applications shall have adequate logical and physical security mechanisms activated to ensure that collection of data does not compromise the privacy of the data;

(i) As to system integrity, only authorized users and patients shall have access to the physical equipment. Users' access shall be limited to those system features necessary to perform their functions; and

(ii) As to program integrity, each health care facility participating in the program shall develop a policy. Such policy shall describe roles and responsibilities of users, owners, and management, in order to protect the equipment, ensure accurate data collection, and provide for privacy and data protection. The policy shall be communicated to staff and enforced by management, including a review of the policy no less than biennially.

(E) Copies of equipment documentation regarding the proper use of equipment, including software and hardware, shall be easily accessible to users. This documentation includes: user manuals, technical documentation, trouble history, and any notes gathered as a result of troubleshooting activity;

(F) Information storage, maintenance, and transmission:

(i) Storage of electronic medical data shall have appropriate fault tolerance and business continuity measures. These measures shall include one or more industry standard implementations such as redundancies and disaster recovery planning in order to reduce the likelihood of permanent loss of data;

(ii) Data and system integrity shall be maintained and organized by qualified personnel. Sufficient maintenance practices or technologies shall be in place to effectively reduce failure incidences and/or their durations; and

(iii) Networks shall, as much as it is reasonable, be protected from undesired intrusion and vandalism. All data transmissions, including classified data transmissions, shall be protected by adequate implementations of security technology.

(G) Technology shall support the synchronization of patient profile data. Business processes and technology shall provide an effective means to authenticate and organize patient information.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 24, 2002.

TRD-200203942

Dirk Jameson

Executive Director

Telecommunications Infrastructure Fund Board

Earliest possible date of adoption: August 4, 2002

For further information, please call: (512) 344-4306