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Federal Technology Transfer Resources in Telecommunications for Health Care

 

I. Background

According to the Congressional Research Service, the federal government spends approximately $74 billion per year on research and development to meet the mission requirements of over 700 government laboratories. It is estimated that one-third of those expenditures are used for intramural research ­ much of which is thought to have significant market value if further developed in collaboration with the industrial community. In short, the knowledge base created by the agencies' R&D activities should serve as the foundation for commercially viable efforts in the private sector.

And yet reports have shown that only 10% of federally owned patents have ever been used. Although there are no similar targeted studies, this amount may be even less as it relates to health care oriented applications of telecommunications. There is never-the-less a growing interest among policy leaders to get federally generated technology as well as technical know-how into the business community, where it can be further developed and subsequently made available to the public in the form of products and services.

The emerging private sector Telehealth community -- including a variety of telecommunications carriers, services providers, device manufacturers, system integrators and others -- should begin thinking about technology transfer opportunities and the established mechanisms available to them which have resulted from more than 20 years of Congressional and Administration enabling efforts.

The stakes are high in consideration of the commitment by the federal government with respect to Telehealth-related research and development. The General Accounting Office has estimated that approximately $646 million if federal funding was spent on Telemedicine across nine departments between fiscal years 1994-1996.

A leader among federal agencies with respect to collaborate research and development in the Telehealth field, the National Library of Medicine requested a report outlining available federal resources with regard to technology transfer for health care oriented applications of telecommunications.

II. Federal Legislative and Policy Directives

A. National Technology Innovation Act of 1980

Federal legislation enacted in 1980, often referred to as the "Stevenson-Wydler Technology Innovation Act", became the initial impetus for a coordinated federal strategy to improve the economic, environmental and social well-being of the United States by promoting technological development. An Office of Industrial Policy was established within the Department of Commerce to establish Centers of Industrial Technology which would:

(1) provide research support of technological and industrial innovation including cooperative industry-university basic and applied research; (2) assistance to individuals and small businesses in the generation, evaluation and development of technological ideas supportive of industrial innovation and new business ventures; (3) technological assistance and advisory services to industry; and (4) curriculum development, training instruction in invention, entrepreneurship, and industrial innovation.

Centers would be affiliated with universities and non-profit institutions, and the National Science Foundation (NSF) was charged with helping to develop centers . In addition to establishing technology centers, Stevenson-Wydler required that each federal laboratory establish an Office of Research and Technology Applications to assess applications for federal research and provide information and assistance both to government agencies and the private sector.

The Act also established within Department of Commerce a Center for Utilization of Federal Technology to:

(1) serve as a clearinghouse for federally-owned or originated technical information with potential application in State or local government or private industry; (2) coordinate the activities of the Offices of Research and Technology Applications; (3) utilize the expertise and services of specified Federal agencies and departments when dealing with State and local governments: (4) refer requests for technical assistance from such governments to the appropriate federal laboratory; and (5) provide funding to federal laboratories to provide technical assistance to governments.

Finally, the law required that the Secretary of Commerce and NSF establish a program to foster the exchange of scientific and technical personnel among academia, industry and the federal laboratories.

B. Federal Technology Transfer Act of 1986

The Federal Technology Transfer Act of 1986 amended Stevenson-Wydler to further promote technology transfer by authorizing federal laboratories to enter into cooperative research agreements and by establishing a Federal Laboratory Consortium for Technology Transfer within the National Science Foundation. The NSF consortium would assist colleges, universities, businesses, non-profit organizations, State or local governments, or regional organizations to establish cooperative programs to stimulate research and encourage technology transfer in such areas as technology program development, curriculum design, long-term research planning, personnel needs projections, and productivity assessments.

The Act also gave new responsibilities to the National Bureau of Standards (now the National Institute on Standards and Technology), established additional technology-transfer related responsibilities for federal laboratories and their Offices of Research and Technology Transfer, and renamed the many Commerce Department Centers for Industrial Technology as "Cooperative Research Centers".

Finally, new authority was given to the Secretary of Commerce to develop model provisions for cooperative research and development, make available agency expertise to other agencies, and furnish other forms of federal assistance to agencies.

C. Executive Order 12591, April 1987

On April 10th, 1987 and Executive Order entitled "Facilitating Access to Science and Technology" was issued by President Reagan to encourage "the swiftest possible transfer of federally developed science and technology to the private sector". E.O. 12591 required Executive department and agency heads to encourage and facilitate collaboration among Federal laboratories, State and local governments, universities, and the private sector, particularly small businesses. Government-owned and operated Federal laboratories were authorized to enter into cooperative research and development agreements (CRADAs) with other federal laboratories, governments and the private sector; waive or assign intellectual property rights; implement royalty sharing programs; provide information and expertise to governments and the private sector; promote commercialization and other tasks.

In addition, the Executive Order established a "Technology Share" program among departments; an "Technology Exchange" program of scientists and engineers; an international science and technology effort to assure that the United States benefits from and fully exploits scientific research and technology developed abroad; special technology transfer efforts within the Department of Defense; and finally a series of "Basic Science and technology centers" under the aegis of Executive level departments and agencies.

D. National Technology Transfer and Advancement Act of 1995

In 1995, Representative Connie Morella (D-Maryland) gained passage of the National Technology Transfer and Advancement Act which further amended the original Stevenson-Wydler Act to among other things revise federal requirements with regard to intellectual property arising from federal-industry cooperative research and development agreements (CRADAs) to provide:

(1) the collaborating partner with the option to choose an exclusive or nonexclusive license for a pre-negotiated field of use for a resulting CRADA invention; (2) confidentiality of commercial information; and (3) limited government laboratory right to require a partner to grant applicant licenses in exceptional circumstances of public health and safety, federal requirements, or partner noncompliance.

The 1995 law also expressly provides that a partner may retain title to an invention made solely by its employees in exchange for granting the government a worldwide license to use the invention, and sets out a process by which individuals may obtain right of ownership or otherwise promote an invention's commercialization if the government chooses not to pursue rights of an invention.

E. Assistive Technology Act of 1998

Further amending the Stevenson-Wydler Act of 1980, the Assistive Technology Act of 1998 was enacted to support grant programs to states to address the assistive technology (AT) needs of individuals with disabilities and for other purposes. The Director of the National Institute on Disability and Rehabilitation Research (NIDRR) in the Department of Education is authorized to work with the Federal Laboratory Consortium (see below) to promote tech transfer that will further the development of assistive technologies and products that incorporate universal design principles. Various efforts are established to develop strategies for applying assistive technologies to mainstream technologies in order to improve economies of scale and commercial incentives.

F. Additional Legislation

In addition to the major legislation summarized above, various laws since 1980 have helped to further clarify and enhance the Federal government's role in the technology transfer process. Included among these are:

 

III. Federal Coordination Activities and National Organizations

A. The Cooperative Research and Development Agreement Process (CRADA)

Defined under the Stevenson-Wydler Act, the cooperative research and development agreement process (CRADAs) establishes authority between universities, the private sector, and government entities to enter into legal agreements to enter into collaborative ventures consistent with an agency or laboratory's mission.

Under a CRADA, title to, or licenses for, inventions made by a laboratory employee may be granted in advance to a participating entity, and the director can waive any ownership rights the government might otherwise claim to inventions resulting from the collaborative effort. As of November, 1998, more than 5,000 CRADAs have been signed.

B. Federal Laboratory Consortium for Technology Transfer

Established in 1974 under the auspices of the Department of Defense, today the Federal Laboratory Consortium for Technology Transfer (FLC) consists of more than 600 member research laboratories and centers from 16 Federal departments and agencies. The FLC helps bring laboratories together with local governments and the private sector in pursuit transfer opportunities. FLC develops and tests transfer methods, addresses barriers to implementation, provides training, and emphasizes national initiatives where technology transfer plays a role.

A volunteer organization Congressionally chartered under the Federal Technology Transfer Act in 1986, FLC allows for swift linkage of federally-developed science and technology with the private sector and governments at a state and local level.

Divided into six geographical regions, FLC encourages close and effective working relationships to quickly identify a potential user's need and the laboratory expertise or capability that could meet that need.

Within Health Care and Medicine, FLC lists several success stories over the years including:

 

Contact:
Sally A. Rood, Ph.D.
Washington, D.C. Representative
Federal Laboratory Consortium for Technology Transfer
1850 M. Street, N.W. Suite 800
Washington, D.C. 20036
Phone: (202) 331-4220
Fax: (202) 331-4290
E-mail: srood @flcdc.cnchost.com

 

C. Small Business Technology Transfer Program
The Small Business Technology Transfer Act of 1992 created a pilot program to facilitate commercialization of university, nonprofit, and federal laboratory research and development by small companies. The Small Business Technology Transfer program (STTR) provides funding for research projects cooperatively developed by small firms, scientists of research organizations and agencies with specific missions. Up to $100,000 in first year proof of concept funding has been available, which may be followed with up to $500,000 for two years to perform research.

D. National Technology Transfer Center
The National Technology Transfer Center (NTTC) at Wheeling Jesuit University works with federal entities like NASA, EPA, Department of Defense, universities, entrepreneurs and companies to take technologies off of laboratory shelves and help commercialize or transfer them into the business sector. NTTC specializes in presenting effective ways to help U.S. corporations and taxpayers access and use federally-financed technologies.

Representatives of NTTC have recently appeared before the federal Joint Working Group on Telemedicine to initiate a dialogue concerning the transfer of federally funded Telemedicine.

Contact:
National Technology Transfer Center
316 Washington Avenue
Wheeling, West Virginia 26003
http://www.nttc.edu

E. NASA Commercial Space Center for Medical Informatics and Technology Applications (CSC/MITA)
Through a major contract with the NASA Division of Aerospace Medicine, Yale University School of Medicine has established a center to discover and develop highly advanced medical technologies, evaluate them in Telemedicine test beds, help incorporate them into space voyages, and to commercialize NASA's operational Telemedicine programs. The Center is dedicated to the maintenance of a U.S. competitive lead in the commercial applications of medical informatics, Telemedicine and advanced medical technologies. Over time, industry partners will include medical equipment manufactures, managed care companies, telecommunications providers and others.

Contact:
CSA/MITA
40 Temple Street, Suite 3A
New Haven, CT 06510
http://www.yalesurgery.med.yale.edu/mita.htm

IV Department / Agency Commercialization and Transfer Activities Within the Field

A. Department of Commerce
As technology transfer-related legislation has evolved, the Department of Commerce, National Technical Information Service (NTIS) has been designated as the official source for government-sponsored U.S. and worldwide scientific, technical, engineering, and business-related information. NTIS maintains a collection of nearly 3 million titles including business studies, technology innovations, marketing reports and other materials on behalf of more than 200 federal agencies. NTIS also tracks contracts and cooperative agreements with the private sector, academia and others.

Within NTIS, a "Joint Venture Program" helps prospective government partners match their capabilities, products and services with agencies who have identified specific requirements.

Contact:
National Technical Information Service
Technology Administration
U.S. Department of Commerce
Springfield, Virginia 22161
Phone: (703) 605-6000
Fax: (703) 605-6900
Web: http://www.ntis.gov

In addition to NTIS, the Commerce Department's Office of Economic Conversion Information (OECI) serves as a clearinghouse of information related to defense downsizing, and can help businesses better appreciate opportunities for civilian application of defense technologies, and commercialization opportunities.

Contact:
Office of Economic Conversion Information
Economic Development Administration
HCHB Room 7231
U.S. Department of Commerce
Washington, D.C. 20230
Phone: 1-8000-345-1222

The National Institute of Standards and Technology (NIST) provides major cooperative agreement funding through the Advanced Technology Program (ATP) for collaborative government / private industry development projects in areas otherwise deemed important yet to risky for independent commercial funding.

While ATP does not fund product development, rather it supports enabling technologies that are essential to the development of new products, process, and services . ATP is of direct benefit to companies of all sizes allowing them to take on technical challenges with larger, broader, and faster payoff potential for themselves and the nation.

During the past few years, major ATP awards have been made in a number of areas broadly classified as Information Infrastructure for Healthcare:

Contact:
Bettijoyce Lide
ATP Project Manager
Phone: (301) 975-2218
E-mail: bettijoyce.lide@nist.gov

C. Department of Defense

While there are many technology transfer-related activities within each of the branches of the armed forces, the Department of Defense has established an overall Office of Technology Transition pursuant to requirements of the Defense Authorization Act of 1993 to:

To help further implement the Act's provisions, the Secretary of Defense established a Defense Technology Transfer Working Group in 1994 with representatives of each military department and most Defense agencies to coordinate policy and approach.

DoD uses CRADAs as well as contracts, cooperative agreements, education partnerships, exchange of personnel, exchange of technical data, grants, licensing agreements and other mechanisms to work with universities, and the private sector in pursuit of technology transfer across domains.

The Dual Use Science and Technology Program approved over 140 projects with over $130 million in federal funds distributed to the services, and while few of these are health -- let alone Telehealth -- related., the Office remains a valuable source of information and potential funding for information technology transfer opportunities in health care.

Another DoD related activity focuses on jointly sponsored workshops and conferences in pursuit of particular technology transfer topics including one held in Virginia in 1996 entitled "The Transfer of Defense, Intelligence, Space, and Energy Technologies to the Early Detection and Control of Cancers in Women".

Within health care, some major focused activities include those of Telemedicine & Advanced Technology Research Center (TATRC) at the U.S Army Medical Research and Materiel Command at Ft. Detrick, the Ballistic Missile Defense Organization (BMDO), and the Defense Advanced Research Projects Agency (DARPA),

The Defense Sciences Office lists a few collaborative projects which are potential candidates for technology transfer including a portable ultrasound device for battlefield trauma including a hand-held imaging device with Telemedicine capabilities being developed in collaboration with Harris Semiconductor, University of Washington, and VLSI Technology Inc.

The Telemedicine & Advanced Technology Research Center works routinely with the private sector and academia in pursuit of research projects of dual use to battlefield medicine, and to the commercial sector.

Technologies and applications being developed with clear implications for eventual commercial uses include:

Beyond immediate battlefield applications and their potential for use by the commercial sector, the TATRC has been integrally involved in collaborative efforts with the National Cancer Institute, the DHHS Office of Women's Health and private sector groups toward the development and implementation of a major Mobile Breast Care Center. The MBCC is thought to have considerable "spinn-off" benefits in the commercial sector as various component technologies become further developed and disseminated.

Contact:
Col. Jeffrey Roller, MC, USAF
Telemedicine & Advanced Technology Research Center
U.S. Army Medical Research and Materiel Command
Ft. Detrick, Maryland 21702-5012
Phone: (301) 619-7967
Web: http://140.139.41.114

The Ballistic Missile Defense Organization has been working extensively with industry to incorporate BMDO-funded technologies into their product lines during the past few years. It is thought that approximately 205 new commercial products have resulted from BMDO-funded technologies, and that over 429 ventures have been formed using BMDO-funded technology as the basis.

Starting in 1994, BMDO began working with the Department of Health and Human Services to transfer technology in the area of breast cancer detection and prevention. Since that time it has expanded these efforts to include collaborative work through the "Federal Multi-Agency Consortium on Imaging technologies to Improve Women's Health" to develop advanced imaging technologies for better screening, earlier diagnosis, and treatment of breast cancer.

The consortium, including representatives of the National Science Foundation, NCI, NASA, DARPA, and others has considered 14 projects (including 6 by BMDO) for funding in areas including: large format digital sensors, active vibration isolation systems, uncooled infrared cameras, polarization imaging and others.

Working with the National Technology Transfer center in Washington, BMDO has issued several important reports including one entitled "BMDO Technologies for Biomedical Applications".

Among various advanced biomedical technologies for observation including those for technology, analysis, diagnosis, as well many interventional technologies including implants and treatment technologies, BMDO lists several which fall under the "Information Technologies" category:

Contact:
Public Affairs, Office of External Affairs
BMDO/SRE, The Pentagon
Washington, D.C. 20301-7100
Phone: (703) 695-8743
Fax: (703) 614-7059
Web: http://www.acq.osd.mil/bmdo/bmdolink

Finally with regard to DoD, the several collaborative efforts of the Defense Advanced Research Projects Agency (DARPA) in recent years have clear implications for the commercial sector. Some telecommunications networking projects with likely spinoff benefits to the commercial health care sector include:

C. Department of Energy
The Technical Information Management Program (TIMP) serves as one of the DOE's mechanisms to coordinate the identification, collection, accessibility, and dissemination of scientific and technical information resulting from DOE research and development programs.

Within individual DOE laboratories, efforts have been made to partner with the academic and commercial sectors to collaborate toward the development and commercialization of advanced telecommunications technologies for a variety of health care applications.

In 1996, Sandia Labs sponsored a major Biomedical Technology Roadmap Workshop to convene and advance the details of previously established work groups tasked with devising strategies for reducing duplication of essential research, addressing technology challenges which may be too costly for individual organizations to bear, and provide a comprehensive view of broader system problems. The resultant publication entitled "Strategies For the Future: The Role of technology in Reducing Health Care Costs", serves as an example of collaborative efforts of more than 150 persons which outlines goals and measurements in many areas relevant to the commercialization of Telemedicine and health oriented applications of telecommunications.

DOE's contribution to the government-wide High Performance Computing and Communications program (HPCC) (now called the Computing, Information, and Communications program) focuses among other things on carrying out collaborative R&D projects with industrial partners , generally through the use of CRADAs..

Contact:
Office of Science and Technical Information
Web:http://www.doe.gov/html/osti/

D. Department of Health and Human Services
The NIH Office of Technology Transfer (OTT) has been charged with evaluating, protecting, monitoring, and managing the NIH portfolio of invention. The office oversees patent prosecution, negotiates and monitors license agreements, and provides central policy review and administration with respect to the CRADA process. The office also manages licensing and patenting activities for the Food and Drug Administration.

For 1998, the NIH lists 287 invention disclosures, 132 patent applications, 215 executed licenses, and 149 executed CRADAs.

 

Contact:
Director, Office of Technology Transfer
National Institutes of Health
6011 Executive Blvd , Suite 325
Rockville, MD 20852
Phone: 301-496-7057
Fax: 301-402-0220
http://www.nih.gov/od/ott

 

Within the Public Health Service, additional Technology Transfer Offices and/or Web Sites may be found at the following Institutes and agencies:

Information may be located regarding technology licensing opportunities, CRADAs, and other processes. For example, the Centers for Disease Control Technology Transfer Office negotiates all CDC CRADA licenses and coordinates all of CDCs licensing activities, in addition to promoting the effective and timely transfer of knowledge and technology towards the development of products and processes that improve public health.

Unfortunately, from NIH's perspective, data are not available concerning inventions and licenses arising from CRADAs. At the same time it is known that the Public Health Service has about 50% of federal CRADAs in the biomedical/biotech areas, a lower proportion of than PHS inventions, indicating static growth of the use of CRADAs within PHS/NIH in recent years.

Yet another important technology transfer activity of the Department of Health and Human Services of potential benefit to the transfer of information technologies for health lies within the NIH Office of Medical Applications Research (OMAR) which manages the NIH Consensus Development program -- considered to be one of the premier health technology assessment and transfer programs in the United States. Among other things, the OMAR coordinates the development and dissemination of both NIH consensus and technology assessment statements, with over 120 having been issued since 1977. Within medicine, these statements often prove critical to the technology transfer process.

Located in the Office of the Director, OMAR staff work closely with the various NIH Institutes and Centers in an effort to improve the process of translating the results of biomedical research into knowledge that can be used effectively in the delivery of health services.

OMAR's "sister" offices include the Office of Disease Prevention, the Office of Dietary Supplements, and the Office of Rare Diseases.

Contact:
Office of Medical Applications of Research
National Institutes of Health
Building 31, Room 1B03
31 Center Drive, MSC 2082
Bethesda, Maryland 20892-2082
Phone: 301-496-5641
Fax: 301-402-0420 FAX
E-mail: jferg@helix.nih.gov

Within the National Library of Medicine, both the National Telemedicine Initiative and the Next Generation Internet (NGI) High-Technology Medical Awards serve as good examples of a government agency partnering with industry and/or academia in pursuit of projects which have great potential for spin-off potential with regard to commercialization.

Promising Telemedicine initiatives announced in 1996 by NLM include:

Among Next Generation Internet, High-Technology Medical Awards announced this past October, several should significantly contribute to the eventual commercialization of the Telehealth field. Some examples include:

Contact:
Michael J. Ackerman, Ph.D.
Assistant Director for High Performance Computing
National Library of Medicine
Building 38A, Room B1N-30
8600 Rockville Pike
Bethesda, Maryland 20894
Phone: (301) 402-4100
Fax: (301) 402-4080
E-mail: ACKERMAN@nlm.nih.gov

E. NASA
The NASA Commercial Technology Division serves as gateway and core resource to the NASA Commercial Technology Network (NCTN) encompassing over 20 Web sites including those of centers, offices and Commercial Technology Transfer centers at 10 NASA field centers.

A wide array of information is available, concerning patents, licensing, partnering opportunities, commercialization opportunities and others.

In recent years, many more NASA resources are available with respect to technology transfer, just as the mission of NASA has evolved in closer partnership with industry. NASA's Tech Finder helps search the new NASATechTracS database of all NASA programs, technologies and success stories which may have commercial potential at the from all 11 NASA Centers.

Among its pioneering accomplishments, the NASA Division of Aerospace Medicine is particularly proud of its long standing history of working collaboratively with academia and industry in pursuit of dual-use technologies.

The NASA Commercial Technology Team lists several large projects as success stories with regard to potential commercialization:

Contact:
Chuck Doarn
Division of Aerospace Medicine
300 E. Street, S.W
Washington, D.C. 20546
Phone: (202) 358-0821
Fax: (202) 358-3038
Web: http://nctn.hq.nasa.gov

F. National Science Foundation
The National Science Foundation supports the technology transfer process through two major mechanisms, Engineering Research Centers and a Small Business Innovative Research program called STTR for Science Technology Transfer Research.

The Engineering Research Centers provide an integrated environment for academe and industry to focus on next-generation advances in complex engineered systems important for the Nation's future. Activity within ERCs lies at the interface between the discovery- driven culture of science and the innovation-driven culture of engineering, creating a synergy between science, engineering, and industrial practice.

Centers form long-term, trusted partnerships between academe and industry and develop a culture where graduate and undergraduate students work in cross-disciplinary teams, in close collaboration with their industrial partners affording them the opportunity over the long run to compete in global markets.

The NSF's SBIR program expands the public/private partnership to include joint venture opportunities for small businesses and the nation's nonprofit academic research institutions. NSF expects synergism in the proposed advanced applied research effort. A team approach is required in which at one research investigator is employed by the small business concern and one investigator is employed by the academic research institution. STTR combines the intellectual strengths and research and development capabilities of both entities by introducing entrepreneurial skills to high technology research efforts. Patent rights are specified in an agreement made prior to the initiation of the joint research effort and commercialization of the innovative technology proposed by the parties is expected.

Contact:
Kesh Narayanan
National Science Foundation
ENG/DMII, Room 590 N
Arlington, Virginia 22230
Phone: (703) 306-1390
Fax: (703) 306-0298
Email: sbir@nsf.gov

 

V. Conclusion

While there are a number of major legislative and policy initiatives in place and available to the emerging field of health care oriented applications of telecommunications, very little actual commercialization has resulted from federal technology transfer mechanisms.

At the same time, there are hundreds of federally funded Telehealth research, demonstration, evaluation, and dissemination activities underway -- many of which will, in time, undoubtedly become candidates for active and robust privatization. Unlike many other technology areas ( including many related to information technologies and/or telcommunications) the Telehealth field has been slow to adopt the widely accepted practices for capitalizing on major federal government investments.

Given the intense interest on the part of Congress and federal policymakers, the issue should become a topic of consideration among federal coordination groups like the Joint Working Group on Telehealth, and the Congressional Ad Hoc Steering Committee on Telehealth and Health Care Informatics.