CHAPTER 5
Medical Technology
CHANGES BROUGHT ABOUT BY MEDICAL TECHNOLOGY
2. Many specialized services have become available in outpatient settings
4. Primary care and public health have received secondary status.
6. Health technology assessment has become crucial to evaluate the usefulness and safety of
new technology
7. Complex social and ethical issues have arisen
WHAT IS MEDICAL TECHNOLOGY?
2. Adaptation of discoveries in other scientific fields (physics, chemistry, engineering, computer
science) to the delivery of medical care
4. Application of technologies to improve the structural elements of healthcare delivery
• Information systems
• Facilities and settings
INFORMATION TECHNOLOGY AND INFORMATICS
IT deals with the gathering, storage, analysis, and transformation of data so it becomes useful
information for health care professionals, managers, payers, patients, researchers, and the
government.
Application of IT in organizations falls in three main areas:
1. Clinical information systems, for example, electronic medical records
3. Decision support systems, for example, analytical tools for advanced decision making. They
include management decision support systems and clinical decision support systems (CDSS).
Management Uses of IT Outputs
Evaluate financial performance, measure utilization of services, assess clinical quality, determine
Health Informatics
It uses IT but goes a step beyond by emphasizing the improvement of health care (efficiency,
accuracy, and reliability of health care services). For example, the use of IT is necessary for
Electronic Health Records (EHR) and Systems
They overcome the drawbacks in paper medical records. They can be used to:
• coordinate care
• measure quality
• reduce errors
EHR systems make medical records part of an interoperable system, and integrate them with
evidence-based clinical decision support. To facilitate the exchange of information across health
care organizations, one emerging model is the health information organization (HIO). Fully-
developed EHR systems should allow (IOM): (1) collection and storage of health information on
Privacy concerns have been the main drawback in realizing the full potential and use of smart
cards in medical care.
E-health
All forms of electronic health care delivered over the Internet by professionals, nonprofessionals,
businesses, or consumers themselves. Tools include secure Internet portals to enable patients to
M-health
Use of wireless communication devices to support public health and clinical practice.
E-therapy
An alternative to face-to-face therapy, mainly in mental health care
The Internet—both physicians and patients are increasingly relying on the Internet for clinical
information.
Telehealth
In addition to telemedicine, it encompasses educational, research, and administrative uses, and it
can involve clinical professionals other than physicians
Synchronous and Asynchronous Telemedicine
Synchronous: real-time interactive videoconferencing, e.g., telesurgery
INNOVATION, DIFFUSION, AND UTILIZATION OF TECHNOLOGY
Diffusion (spread, availability) and utilization (aggregate use) go hand in hand. Both are
important factors in medical cost escalation.
Innovation sees rapid diffusion:
• When new technology is beneficial and the benefit can be evaluated
• When technology is compatible with the adopters’ values and needs
FACTORS THAT DRIVE INNOVATION AND DIFFUSION
1. Cultural beliefs and values
2. Medical specialization
3. Financing and payment
Many other countries use fixed payments for providers. It curtails the incentive to use
4. Competition
• Competition among hospitals on the basis of technology
5. Expenditures on R&D
6. Supply-side controls
• Americans resist supply-side controls
7. Government policy
• Control over the availability of drugs, devices, and biologics
• Indirect influence over innovation by controlling funding for biomedical research
REGULATION OF DRUGS , DEVICES, AND BIOLOGICS
The FDA’s drug approval process includes safety, effectiveness, and access by prescription or
over the counter. Table 5-2 summarizes FDA legislation.
Device Categories
Medical Device Amendments, 1976 (to the FD&C Act of 1938)
o Class I – only subject to controls over fraudulent claims of effectiveness
Regulation of Biologics
The FDA regulates biologics under the Public Health Service Act of 1944, the Food, Drug, and
Cosmetic Act of 1938, the Biologics Price Competition and Innovation Act of 2009, and the
Biosimilar User Fee Act of 2012.
The ACA of 2010
• A 2.3% excise tax on the sale of certain medical devices by manufacturers and importers
of these devices became effective on January 1, 2013.
of generic drugs and to charge the developers a user fee.
• 12-year patent protection for the developers of the original reference product
CON LAWS
o Federal CON requirements discontinued in 1987
IMPACT OF MEDICAL TECHNOLOGY
• Quality of care—our notion of quality is often associated with high technology. Technology
has improved diagnosis and treatment—more effective, less invasive, safer procedures—
resulting in greater life expectancy and decreased morbidity and disability.
• Quality of life—technology enables people to live more normal lives than would otherwise be
barcoding and scanning systems, teleconferencing, continuing education, managed care
organizations.
HEALTH TECHNOLOGY ASSESSMENT (HTA)
Examination and reporting of properties of medical technology:
Safety, effectiveness, feasibility, indications for use, cost, cost-effectiveness
Social, economic, and ethical consequences
Together these factors define how “appropriate” the technology is. Assessment results serve as a
guide for the adoption and diffusion of new technology. Efficacy and safety are evaluated
through clinical trials.
• Efficacy (effectiveness)—determination of health benefits (outcomes), more accurate
Staff time, space requirements, mix of specialist vs generalists, risk, etc.
Benefits: Evaluated in terms of health outcomes
Efficacy, prognosis, number of disease cases averted, years of life saved,
DIRECTIONS AND ISSUES IN TECHNOLOGY ASSESSMENT
• Mainly private sector initiatives. DVA and Department of Defense carry out most
assessments in the public sector.
• Coordinated effort between the private and public sectors is needed
• Results of effectiveness and cost-effectiveness research from various sources need to be
comparable. Standardization of methods and benchmarking are needed.
o Should society pay for novel treatments that do not affect health and longevity?
TERMINOLOGY
• Administrative information systems—Designed to assist in carrying out financial and
administrative support activities such as payroll, patient accounting, materials management, and
office automation.
• Asynchronous technology—Use of store-and-forward technology that allows the users to
review the information at a later time.