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Home < Telehealth <
 TELEMEDICINE
Creating Virtual Certainty
Out of Remote Possibilities
Prepared by Robert Milstein, Consultant
An International, Comparative
Analysis of Policy, Regulatory and Medico-Legal Obstacles and Solutions
Table of Contents - Full Version
(A copy of the full version is available on request by sending an
email to either Mr Bob Milstein, bob_milstein@corrs.com.au or Mr Keith
Kranz, keith.kranz@dhs.vic.gov.au providing the following details : full
name, position title, company and email address. The abridged version
is available online click here to view the abridged
version )
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
CHAPTER 1. INTRODUCTION
CHAPTER 2. THE POLARITIES
Why the polarities?
CHAPTER 3. DEFINITIONS
The importance of definitions
A multifaceted approach
(a) The setting
(b) The technology
(c) The activity
(d) The process of care
(e) The medical discipline/clinical application
Different clinical applications generate different policy, regulatory
and medical-legal issues
Guiding principles and working definitions of this Report
CHAPTER 4. SCOPE OF THIS REPORT
The policy and regulatory context of Telemedicine
US Council on Competitiveness: conceptual model
Part of a larger information infrastructure
Health information infrastructure/ "Healthcare Infocosm"
National/Global information infrastructure/ "the information
super highway"
Many Australian bodies currently analyzing "Information Economy"
issues
What this Report will not address
Policy issues outside/beyond the health information infrastructure
which also confront telemedicine
Policy issues relevant to segments of the health information infrastructure
other than telemedicine
Multiple, critical success factors affecting telemedicine which are
beyond the scope of this Report
(a) Technical infrastructure issues
(b) Human infrastructure issues
(c) Evaluation framework for assessing cost-effectiveness and medical
usefulness
What this Report will address
What this Report will seek to achieve
No easy answers
Identifying, categorizing and analyzing the issues
Identifying the "show stoppers"
CHAPTER 5. THE TELEMEDICINE POLICY AND REGULATORY
ENVIRONMENT IN NORTH AMERICA: WHY SHOULD WE COMPARE AND COLLABORATE?
Acknowledgement of significant differences
Given these differences, why should we look abroad?
Factors supporting international comparative perspective
Common problems generating similar solutions
Globalization
Of ICT in Health
Of medical-legal trends
USA's "economies of scale" as a testbed for experimentation
and innovation
US as telemedicine leader
The American scene
Federal Activity
State/Regional Government Activity
National standards-setting bodies/professional organizations
Publications/Conferences
Litigation?
Reasons for dearth of judicial opinion to date
CHAPTER 6. TELEMEDICINE AND MEDICAL LIABILITY
The "telephone as telemedicine" analogy
A fair analogy?
Funding and Regulatory Repercussions: are "Telephone Legal Issues"
the same as "Telemedicine Legal Issues"?
An inadequate analogy: reasons
Liability issues posed by telemedicine: "evolutionary" or
"revolutionary"?
Current common law as facilitator of change
Current common law as an impediment to change
Scope of this Report
Central Thesis
Features of Telemedicine that may Generate Novel or Complex Liability
Questions
CHAPTER 7. BACKGROUND: THE THEORY AND PRACTICE
OF MEDICAL LITIGATION
Theoretical orientation - the law of negligence
Practical orientation: the realities of litigation
CHAPTER 8. THE DUTY OF CARE
General principles
Individual
Corporate
Issues/Problems raised by telemedicine
Telemedicine treatment scenarios
How telemedicine differs from conventional scenarios
The remote consultation and the duty of care
American approaches to telemedicine duty of care issues
Conclusion
Duty of care owed other than by "telepractitioners"
Health care institutions
Persons other than medical practitioners
Within the clinical setting
Outside of the clinical setting
Conclusions/Reform and Risk Management options
CHAPTER 9. THE STANDARD OF CARE AND STANDARDS-SETTING
ISSUES
A. The standard of care in negligence law
General principles
The individual healthcare practitioner
Healthcare institutions
"Reasonableness" depends on all the circumstances
Issues/Problems posed by telemedicine
The standard of care and the risks/limitations of telemedicine
Human issues
Between patient and provider
Telemedicine and "informed consent"
As between "hub" practitioner and "spoke"
practitioner
Example: "proxy" examinations/investigations
Conclusion
Technical issues
Conclusion
Will telemedicine attract a modified standard of care?
Conclusion
The standard of care and the failure to use telemedicine
B. Standards/standardization
Are standards achievable/desirable at this time?
The need for standards/standardization
American approaches-examples
1. American College of Radiology (ACR)
2. Report of the Interdisciplinary Telehealth Standards Working
Group (ITSWG)
ITSWG "Core Principles"
C. Reform/Risk Management options
Physicians Insurers Association of America (PIAA) and Telemedicine
Risk Management
Questions to be addressed at Organisational Level
Institute of Medicine (IOM) checklists
Telemedicine and Risk Management: the good news
CHAPTER 10. TELEMEDICINE AND EVIDENTIARY ISSUES/RAMIFICATIONS
Telemedicine compared with conventional care delivery
Evidentiary repercussions of telemedicine: opportunities and challenges
"Extra" witnesses
Videotaped evidence
Other potential challenges
Audit trail
Identifying and retaining the "original" document
New communication tools pose new liability risks
Risk Management options
Education and coordination
Risk reduction strategies
Telemedicine and admissibility issues
CHAPTER 11. CROSS-BORDER/INTERSTATE ISSUES
Introduction
Section A: Cross-Border Telemedicine and Litigation: jurisdictional
and choice of law issues
Introduction
Private International Law
Jurisdiction
Choice of Law
Telemedicine and Jurisdictional/Choice of law issues-summary
Options for reform
Section B: Telemedicine and registration/licensure of medical practitioners
Introduction
Scope of this Section
Common issues, common challenges
Similar but not identical
Mutual Recognition Act 1992
Remaining problems
A. Where is the doctor practicing - jurisdiction
B. The "practice of medicine"
C. Inconsistency/variability and conflict between the local laws
etc.
D. Other forms of cross-border medicine
CHAPTER 12. TELEMEDICINE AND PRIVACY, CONFIDENTIALITY
AND SECURITY ISSUES
Introduction
Scope of this Chapter
Background: concerns about the protection of health information
Definitions
Striking a balance
New challenges, "old" challenges and new opportunities
Vulnerability of the paper-based medical records system
Relevance of institutional (not just technological) issues
Electronic storage and management - a new tool for better protection
of privacy, confidentiality and security
Challenges posed by electronic storage and management
The US Scene
Telemedicine - are there unique issues?
Reform/Risk Management options
Institutional measures
Technological change
Organizational practices
CHAPTER 13. TELEMEDICINE AND REMUNERATION/REIMBURSEMENT
ISSUES
Introduction
Australian initiatives
Scope of this Chapter
(a) Focus on remuneration of practitioners rather than on other costs
of telemedicine
(b) Focus on challenges to private sector remuneration
(c) No detailed discussion of cost-benefit or evaluation issues
Remuneration for telemedicine: challenges and concerns
Definitional challenges
New models for interaction that transcend/ignore traditional boundaries
Transcending of organizational and funding boundaries
Whose costs? Whose benefits?
Is it worthwhile?: lack of knowledge concerning cost-effectiveness
and clinical utility/quality/safety
Other cost concerns
US initiatives
(a) Medicaid
(b) Medicare and HCFA
A. Telemedicine demonstration program
B. Balanced Budget Act
(i) Demonstration project using "eligible health care provider
telemedicine networks"
(ii) Extended coverage for designated rural "health professional
shortage areas"
C. HCFA regulations regarding rural HPSAS
(i) Definitions
(ii) "Store-and-forward"
(iii) Types of service providers covered
(iv) Payment
(v) Identifying the site of service
D. Responses to and criticisms of the HCFA regulations
(i) Definitions and inclusion of store-and-forward technology
(ii) Participation of referring practitioner
(iii) Bundled payments and the "self-referral law"
E. HCFA response
Conclusion
CHAPTER 14. CONCLUSION
APPENDIX I : SELECTED READING LIST
APPENDIX II : LIST OF PERSONS/INSTITUTIONS CONTACTED
Updated
1 December 2001
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