Telemedicine & Health Care Informatics Legal Issues

Copyright 1996-97 William L. Manning except as otherwise noted. All rights reserved.

Last updated by Bill Manning on 8/03/97

About This Page The increasing computerization of health care data, combined with the emergence of new telecommunications applications and technologies create vast opportunities for the provision of health care. Some of the legal and regulatory issues, though, seem way behind the curve. This page is devoted to these legal issues. Telemedicine "began" in the 1960s as medical treatment rendered over the telephone and by wire by physicians who were physically remote in relation to the patient. Although today, the principles are largely the same, the technology and milieu of contemporary telemedicine are vastly different. In the age of high-speed data lines, advanced data compression technologies, the privatization of defense technologies, and computerization of patient records, clinical outcomes and physician practices, telemedicine promises to be the next milestone of health care advances. Health care informatics is the study relating to the development and application of information technology to health care information. CHINS, electronic patient records, clinical guidelines and clinical pathways are examples of health care informatics applications. The proliferation of interest in telemedicine and health care informatics has centered on the technical and sociological aspects of the medium. It is only recently, however, that legal and regulatory issues have been discussed. In fact, the potential for mass availability of telemedicine will likely depend upon how the legal and regulatory issues are resolved. This page of The Health Law Resource is devoted to discussing some of these issues and to provide links to other related sources on the internet for the interested practitioner, scholar or consumer of health care or legal services.

What's

HHS Operational Policy Letter #41: Medicare Managed Care And Telemedicine Services, HCFA, November 4, 1996 Telemedicine services may be offered by the managed care plan to its enrollees in the same manner as other services not covered by Medicare.

Telemedicine Reimbursement Approved by Congress; Agreement Hailed as Victory for Advocates of Telemedicine, WASHINGTON, /PRNewswire/, 7-31-97.

 Selected Resources

• Telemedicine

• Telemedicine And The Law: Overview of Legal Issues Presented by Telemedicine, by Sharon Klein and William Manning.
• Digest From OTA Report on Telemedicine
• Telemedicine: Western Governors' Association Telemedicine Action Report.
• Telemedicine Report to Congress, Posted 01-31-96
• Draft Model Physician Licensure Act - Adopted by The Federation of State Medical Boards
• HHS Operational Policy Letter #41: Medicare Managed Care And Telemedicine Services, HCFA, November 4, 1996 Telemedicine services may be offered by the managed care plan to its enrollees in the same manner as other services not covered by Medicare.
• California Telemedicine Development Act of 1996, requires, as of July 1, 1997 all private insurers and the Medi-Cal program to establish a reimbursement policy and clarifies existing law and allows for interstate "teleconsultation" without a license.
• Selected Bibliography on Telemedicne, American Association of Health Plans (AAHP).
• Telemedicine: Federal Strategy Is Needed to Guide Investments, GAO Report HEHS 97-67.
• International Licensing of Intellectual Property, Nicolas S. Gikkas, International Licensing of Intellectual Property: The Promise and the Peril, 1 J. TECH. L. & POL'Y 6 (1996)

• Relevant AMA Opinions & Standards

  • 5.025 Physician Advisory or Referral Services by Telephone. Expressly applicable to telemedicine patient"encounters".

• Samples of Other Legislation

  • 1996 Telecommunications Act telemedicine provisions

• FDA Regulation

  • FDA Workshop Materials on Clinical Software 9-3-96. Peek at what the FDA is thinking about in the certain forthcoming regulation of clinical care software applications.
  • FDA's Statement on Telemedicine Software And Devices- From the FDA Center on Devices and Radiological Health.
• FCC Regulation of Telemedicine (looking for articles on this topic - any contributors?)
• sci.med.telemedicine: Usenet news group.

Health Care Informatics

• Clinical Data Management and Privacy Issues, by William L. Manning
• HEDIS 3.0 Executive Summary, from NCQA.
• An Information Systems and Technology Primer, American College of Physician Executives, Forum on Information Systems and Technology, May, 1996.
• Policy Implications of Medical Information Systems, OTA Report (December 1977).
• Bringing Health Care Online: The Role of Information Technologies, (September 1995).
• Accessibility and Integrity of Networked Information Collections, OTA Report (August 1993).
• Know Legal Consequences of Collecting Data, by Gregory L. Pemberton, ©1996 Ice Miller Donadio & Ryan.
• Consumer Health Informatics: Emerging Issues., GAO/T-AIMD-96-134, July 26, 1996.

• Relevant AMA Opinions & Standards

  • 5.07 Confidentiality: Computers.
  • 5.075 Disclosure of Records to Data Collection Companies.

  
  

  Digital Signatures

  • Trends: Digital Signatures, by Simson L. Garfinkel, MIT Technology Review: Nov/Dec., 1996.
  • ABA Digital Signature Guidelines, from the American Bar Association's Electronic Commerce and Information Technology Division, Section of Science and Technology.
  • Digital Signature Legislation: Some Reasons For Concern, by C. Bradford Biddle.
• The Impact of Kennedy-Kassebaum, epn.org: Idea Central Health policy page, August, 1996.
• FDA Workshop Materials on Clinical Software 9-3-96. Peek at what the FDA is thinking about in the certain forthcoming regulation of clinical care software applications.
• The Privacy Protection Act in Cyberspace by Steven Jackson Games, April 1995 (from Federal Law Enforcement Training Center)
• Electronic Data Interchange and Paperless Processing: Issues and Challenges, from SBA (March 1994). HHS-OIG Inspection and Evaluation Reports - HCFA

• International Sources

  • Privacy and security of personal health information in Australia From the March 1996 Journal of Informatics in Primary Care 1996 (March):15-17.
  • The European 1985 Directive) . Convention for the Protection of Individuals With Regard to Automatic Processing of Personal Data
  • Directive: The Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data.
  • Data Privacy's Decline in America Exposes its Popularity Elsewhere , by Wayne Madsen. A discussion of data privacy protection in developing countries and in the former Eastern bloc.

• Samples of Other Legislation

  • S. 1360: Proposed Medical Records Confidentiality Act of 1995 ("Bennett Bill")
    • Digest of the legislation
    • Full Text Version(s)
• sci.med.informatics: Usenet news group.

Recently in The News

• Telemedicine Reimbursement Approved by Congress; Agreement Hailed as Victory for Advocates of Telemedicine, WASHINGTON, /PRNewswire/, 7-31-97.
• Telemedicine: Clinical Benefit, But Cost-Effectiveness Unproven, Reuters, 7-07-97
• Oklahoma Telemedicine Act of 1997, Signed by the Governor of Oklahoma on May 21, 1997.
• NCQA Releases Auditing Standards For HEDIS, Reuters, 4-15-97.
• Home Healthcare Via Telemedicine: A Report From Information for Tomorrow Says The New Frontier of Healthcare...Is in Your Grandmother's Living Room, 4-3-97, PRNewswire.
• NCQA Recommends Improvements To Managed Care Info Systems, Reuters, 3-28-97. Law Group Formulates Uniform Rules for Online Transactions, Kathleen Murphy, Reprinted from Web Week, Volume 4, Issue 5, 3-17-97.
• Georgetown University Medical Center, Multimedia Medical Systems Launch First-Ever Telemedicine Renal-Dialysis Project, PR Newswire, 3-12-97.
• HEDIS Reporter Software Launched, Reuters, 3-11-97.
• Rx for Privacy: Improve Security of Medical Records, Kerry Hall, Medill News Service, PCWorld Online, 3-10-97.
• AHCPR To Demonstrate Use of Computerized Decision-Support Software in Clinical Practice, AAHP Medical Affairs Update, February 1997.
• Automation Fosters Health Care Fraud, By Malcolm K. Sparrow, Feb 97
• PRIVACY AND THE NII: Safeguarding Telecommunications-Related Personal Information The Information Infrastructure Task Force (IITF), Information Policy Committee, Privacy Working Group has released the Final Version of Privacy and the NII: Principles for Providing and Using Personal Information. NTIA staff made major contributions to the development of this document.
• FDA Workshop Materials on Clinical Software 9-3-96

 Explore These Relevant Links

• Wired Senses. Interactive mental health counseling on the Internet via Email and Cu-SeeMe.
• Arent Fox's Telemedicine Page
• Telemedicine Information Exchange
• Telemedicine Information Exchange What's New
• HIS Focus, Aspen Systems Corporation, Quarterly Information Services Newsletter for Health Care Professionals.
• Telemedicine Funding Search, Use this form to search for information about funding available for telemedicine projects and research.
• FDA, Center for Devices and Radiological Health
• Latest News from the FDA
• News Headlines: Electronic Data in Health Care
• Medical Informatics Directory at Silverplatter: Announcements and links in the field.

Register to Receive E-Mail When This Page is Updated.

Last updated by Bill Manning on 8/03/97

Visitors Since 1/06/97