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Medical Technology

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on 10 March 2015

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Transcript of Medical Technology

Medical Technology
Innovation, Diffusion, and Utilization of Medical Technology
Technology diffusion refers to the spread of technology into society once it is developed.
Diffusion of a technology occurs when the innovation is beneficial and the benefit can be evaluated or measured, is compatible with the adopter’s values and needs.
Technological imperative means that people desire to have innovated technology available, despite the cost.
The diffusion and utilization of technology are closely interacted.

Regulation of Cost: Certificate of Need (CON)
Implemented under the National Health Planning and Resources Development Act (1974)
Purpose: To influence the diffusion of technology by requiring hospitals seek state approval before acquiring major equipment or new construction

Regulation of Drugs and Devices
2006- Patriot Act (Bush)
Cold & Allergy Medicine s containing pseudoephedrine are required to be kept and sold behind the counter
Purchasers must show ID & sign a logbook
There are legal limits on the amount you can purchase
Cost Efficiency
Weighs benefits against cost
Cost Effectiveness Analysis
Incorporates both costs and benefits
Usually not expressed in dollar amounts
Cost Benefit Analysis
Incorporates both costs and benefits
Expressed in dollar amounts
Four Main Assumptions:
1) health condition can be identified
2) Problem can be controlled using appropriate intervention
3) Benefit or outcome can be assigned a dollar amount
4) Cost of intervention can be determined in dollars
Same Principles
If the estimated benefits exceed costs, the additional spending on medical care is worth the extra costs
Quality adjusted life year (QALY)
is a measure of health benefit
Analyses that includes QUALYs are
cost-utility analysis
Current & Future Directions in Health Technology Assessment (HTA)
Need for Coordinated Effort
Need for Standardization
Balance Between Clinical Efficacy & Economic Worth
Clinical Practice Guidelines
Ethical Issues
HIT system vendor-provider relationships
Patient safety
Liability
Security
Surveillance
Research ethics
Autonomy and empowerment
Social networking
Policy and Regulation

(AMIA, 2015)
References
American Medical Informatics Association. 2015. Ethical, Legal, and Social Issues. Retrieved from https://www.amia.org/programs/working-groups/ethical-legal-social-issues
Gabriella Klipp
Paige Bathersfield
Yifei Huang
Kendra Singh
Cristine May Sumalinog

Background on Drug Regulation
Research on Technology
The Impact of Medical Technology

Criticism and Orphan Drug Act of 1983
Agency for Healthcare Research and Quality
Established under the Omnibus Budget Reconciliation Act (1989)
Previously known as Agency for Health Care Policy and Research
The purpose is to support research that focuses on the improvement of quality, reduction of health care costs, and improvement of access to essential services.


provides extensive adaptations of modern treatments to alternative settings (home health, outpatient t)
has turned hospitals into capital-intensive institutions, where the latest diagnostic and therapeutic remedies are offered
telecommunications technology used in telemedicine is also used for administrative teleconferencing and medical education.
technology plays a vital role in monitoring cost effectiveness and quality and tracking referrals to specialized services

The FDA received criticism for slowing down the introduction of new drugs
In response, the Orphan Drug Act was passed to provide incentive to pharmaceutical companies to develop new drugs for rare diseases
Exclusive Marketing rights (7 years)
Grant Funding
Orphan Drugs- pharmaceutical drugs that has been developed specifically to treat medical conditions that affect fewer than 200,000
Impact On Global Medical Practice
Facts of Healthcare Innovation in the U.S
- gives many nations access access to high-technology medical care with less national investment
Impact on Bioethics
High-tech procedures are more readily available in the United States than in most other countries, and little is done to limit the expansion of new medical technology.
By contrast, almost all other nations have tried to limit, mainly through central planning, the diffusion and utilization of high-tech procedures to control medical costs.
Certain investments in healthcare information technology in the U.S have particularly lagged behind other countries. (ex. Smart cards)

Factors That Drive Innovation and Diffusion
Impact on Access
Cultural beliefs and values
Medical specialization
Financing and payment
Competition
Expenditures on R&D
Supply-side controls
Government policy
- allows remote access to centralized equipment and specialized personnel by providing mobile equipment or by employing new communications technologies.
Cultural Beliefs and Values
Comparative public opinion surveys in Europe and the United States indicate a much greater belief in the benefits of technology in this country.
40% of Americans believe that medical technology can always save their lives.
The emphasis on specialty care, rather than primary care and preventive services, raises the expectations of both physicians and patients for the use of all available technology.
Impact On Structure and Processes of Health Care Delivery
Medical specialization & Financing
Physicians’ exposure to technology early in training affects clinical preferences and future behavior and practice patterns.
Patient demand for direct access to specialists is growing in the United States, which reflects the population’s desire for high-technology medicine。
Oversupply of specialists in the United States has compounded the rate of technology diffusion.
There is a two-way relationship between technology diffusion and insurance coverage:
Increasingly generous insurance coverage causes increases in spending for new products.
The development of beneficial but costly new technology puts pressure on insurers to cover those costs.

Competition
Hospitals as well as outpatient centers compete to attract insured patients.
Well-insured patients look for quality, and institutions create perceptions of higher quality by acquiring and advertising newest technology.
To recruit specialists, medical care centers often have to obtain new technology and offer high-tech procedures.

- raising serious ethical and moral issues
Expenditures on Research and Development & Supply-Side Controls
Government Policy
Managed Care and Technology Diffusion
Managed care has played a key role in slowing the surging cost of health care.  
A study conducted in 1998 examined the relationship between HMO market share and the diffusion of MRI equipment, and found out that increases in HMO market share are associated with slower diffusion of MRI into hospitals between 1983 and 1993, and with substantially lower overall MRI availability in the mid- and later 1990s.
High managed care areas also had markedly lower rates of MRI procedure use. Results suggested that managed care may be able to reduce health care costs by influencing the adoption and use of new medical equipment and technologies

Managed care has played a key role in slowing the surging cost of health care.  
A study conducted in 1998 examined the relationship between HMO market share and the diffusion of MRI equipment, and found out that increases in HMO market share are associated with slower diffusion of MRI into hospitals between 1983 and 1993, and with substantially lower overall MRI availability in the mid- and later 1990s.
High managed care areas also had markedly lower rates of MRI procedure use. Results suggested that managed care may be able to reduce health care costs by influencing the adoption and use of new medical equipment and technologies
Source: Baker, L. C., & Wheeler, S. K. (1998). Managed care and technology diffusion: The case of MRI. Health Affairs, 17(5), 195-207.
Impact on Health Care Costs
- may increase both labor and capital costs due to:
there is the cost of acquiring the new technology and equipment.
specially trained physicians and technicians are often needed to operate the equipment and to analyze the results, which often leads to increases in labor costs.
new technology may require special housing and setting requirements, resulting in facility costs.
- technology in the health care field demonstrates a unique characteristics.
- may reduce health care costs and labor costs
Overall reduction in the average length of inpatient hospital stays.
Antiretroviral therapies have been largely credited with the dramatic reduction in hospitalization of AIDS patients.
Installation of automated lab dropped the human handling steps from 14 to 1.5 and the turnaround time from 8 hours to 90 minutes resulting in significant drop in labor costs.
The Assessment of Medical Technology
Health technology assessment (THA)
- also known as technology assessment, refers to any process of examining and reporting properties of a medical technology used in health care, such as safety, effectiveness, feasibility, and indications for use, cost, and cost-effectiveness, as well as social and economic, and ethical consequences whether intended or unintended.
- efficacy and safety are the basic starting points in evaluating the overall utility of medical technology, both are evaluated through clinical trials.
Efficacy

- health benefit derived from the use of technology
- if a technology is not efficacious, it should not be used.


Safety
- are designed to protect patients against unnecessary harm from technology
- outcomes from the wider use of technology are closely monitored to identify any problems related to safety
Swann, Ph.D., J. (n.d.). FDA's Origin. Retrieved March 4, 2015, from http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm
Food & Drug Administration (FDA)
Agency of US Department of Health of Health and Human Services (DHHS) aka The Health Department
Previously known as the Bureau of Chemistry
Started with one chemist!



While intending to describe the harsh conditions to which immigrants were subjected to in Chicago, Sinclair ultimately exposed the horrific unsanitary conditions in the meat-packing industry.
Upton Sinclair's The Jungle (1906)
Samuel Hopkins Adam's The Great American Fraud (1906)
Exposed the false claims, harmful ingredients, and market manipulation of drugs and their producers.
Society of Toxicology. (n.d.). Retrieved March 4, 2015, from http://www.toxicology.org/gp/fda.asp
Weighing the Outcomes of New Technology
Analysis of Pros and Cons
Factors in Demand for New Technology
Patient Rights
- Patient has the ability to chose how they want to be treated so long as it's in accordance with the 3rd party biller or based on their own budget if costs are coming out of pocket
Consumerism
- Patients expect newer technology to be better

- May take advantage of a 3rd party payee because they are not responsible for total bill

- Supply the market for the demand of new technology
Cost
- Research needs to be done as a preliminary to create new technology. Safety is key issue in usage of device or pill

-Skilled professionals must hired to operate the equipment

- Facilities must be able to afford new equipment that is introduced to the market
Social and Ethical Concerns
- Should certain technology be used? Stem-cell research

-Increasing Human Life Span: Up to what point should technology intervene with humanism?

-Death is a part of Humanity
Foods and Drugs Act (1906)
The first drug legislation passed in the United States
The FDA was now authorized to take action against producers of drugs that caused harm
However, there were no drug inspections of preventative measures taken.
It was assumed that the manufacturers would conduct safety tests before marketing the product
The Sulfanilamide Disaster and The Federal Food, Drug, and Cosmetic Act of 1938
Pure Food and Drugs Act did not do enough to protect public safety.
In 1937, Elixir Sulfanilamide was distributed for streptococcal infections.
It used diethylene glycol, a chemically similar to antifreeze, a toxic solvent .
It caused over 100 documented deaths in Tennessee and other states, including many children.
Led to 1938 Drug And Cosmetic Act of 1938, which states that FDA must be notified prior to marketing.
Medical Tech
Types of Medical Technology
In the United States, direct controls over the innovation, diffusion, and utilization of technology through government policy have not been possible.
However, the U.S government is one of the largest sources of funding for biomedical research.
By controlling the amount of funding, public policy can indirectly influences medical innovation.
Importance of Information Technology
Monitor medication, avoid errors, reduce adverse reactions as well as billing and collecting money for procedures
Health Informatics: using IT to deliver a higher quality of health care delivery
EHR: Electronic Health Care Records; ability to access individual records online from separate, interoperable automated systems within an electronic network. Main Benefit: PORTABILITY
Health care economists estimate that 40–50% of annual healthcare cost increases can be traced to new technologies or the intensified use of old ones. 
Most countries employ supply-side rationing to limit the diffusion of medical technology, while Americans resist it.
To control the use of medical technology can cut costs, but it also restricts access to care that is critically needed.

Thalidomide Scandal and Kefauver-Harris Amendment (1962)
Thalidomide was distributed after being marketed in Europe as a sleeping pill
It was sold in United States as an experimental drug
Pregnant women who consumed Thalidomide had babies born with birth defects
As a result, the drug approval system was further amended in 1962
The FDA now took charge of reviewing and assessing the safety and efficacy of drugs BEFORE marketing
Cons to EHR's
- Key Issues: Expense and Confidentiality

- Initial Starting costs: $37,000-$64,000

- HIPAA: protects patient privacy and immlements
criminal penalties if information is used
unlawfully
Funding for Research
Controversial Technology Usage
The National Institutes of Health
Provides financial support for biomedical research
Also conducts their own biomedical research
- E- Health: all forms of electronic health care delivered over the internet ranging from informational , education and commercial products to direct services offered by professionals
SELECTED RESEARCH ADVANCES OF NIH. (n.d.). Retrieved March 4, 2015, from http://history.nih.gov/about/timelines_research_advances.html
M- Health and E- Therapy
- M- Health: use of wireless
communication devices to
support public health

- E-Health: online counseling.
Issue: not effective for all
health disorders.
The Ebola vaccine was tested at the NIH Clinical Center, which also provided care to the nurse who had contracted the Ebola virus.
Impact of Medical Technology
Impact on Quality of Life
Advanced technologies can provide quicker, more precise medical diagnosis
More effective, less invasive treatments
Angioplasty vs. Morphine and Nitroglycerin
Angioplasty vs. Coronary Bypass

Other EXAMPLES
Laser Surgery
Robot- assisted surgery

MRI
X-Ray
CT Scan
Pet Scan
Bioimaging Methods provide ways to see inside of the body
Technology & Molecular and Cell Biology
Genetic Testing
Xenografting- A surgical graft of tissue from one species to a different species (e.g. animal to human)
Bioartificial organs
Food & Drug Administration Modernization Act (1997)
"Fast track" approval for new drugs for serious life threatening conditions
Must be considered significantly greater than current therapies
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