HCA chapter 5

HITECH Act of 2009

"health information technology for economic and clinical health"; provides financial incentives to providers for adopting meaningful use of EHR technology

cost increases associated with new medical technology

-acquisition costs are often high because of R&D and precision manufacturing -training and hiring of technicians with special skills -facilities may require refurbishing or expansion to accommodate the new technology -utilization when covered by insurance (moral hazard and provider induced demand)

key components of electronic health record system

-collection and storage of information on individual patients over time, where health information is defined as information pertaining to the health of an individual or health care provided to an individual -immediate electronic access to individual and population level information by authorized users -provision of knowledge and decision support that enhances the quality, safety, and efficiency of patient care (health informatics) -support of efficient processes for health care delivery

mechanisms to control the growth of technology

-implement central planning to determine how much technology will be made available and where -withdraw federal funding for R&D -change the patterns of medical training, placing greater emphasis on primary care practice -reduce the number of speciality residency slots for medical graduates -curtail insurance payments for expensive medical treatments -impose controls on pharmaceutical prices, which in turn will make less money available for R&D and development of new drugs

barriers to adoption of telemedicine

-licensure of physicians and other providers across state borders -concerns about legal liability -lack of reimbursement for services provided

cost-saving medical technology

-replacement of earlier, more expensive products -minimally invasive procedures that eliminate the need for overnight hospital stays -technologies that shorten hospital stays -drugs that reduce inpatient psychiatric care -technologies that enable services to be rendered in outpatient and home care settings instead of hospitals

major reasons that the US leads all other nations in the development and use of technology

1) cultural beliefs and values 2) medical training and practice 3) insurance coverage 4) competition among providers

diagnostic equipment

CT (computerized tomography) scan MRI (magnetic resonance imaging)

Class III

Devices that come under the most stringent requirements of premarket approval regarding safety and effectiveness. Devices in this class support life, prevent health impairment, or present a potential risk of illness or injury. examples include implantable pacemakers and breast implants

1962 Drug Amendments

FDA takes charge of reviewing efficacy and safety of new drugs, which can be marketed only once approval is granted. passed after the thalidomide tragedy --> in europe it was marketed as a means of preventing morning sickness and thousands of deformed infants were born to mothers who had used this new drug its consumer protection role now enabled the FDA authority to review the safety as well as the effectiveness of a new drug before it could be marketed

Safe Medical Devices Act of 1990

Health care facilities must report device-related injuries or illness of patients or employees to the manufacturer of the device, and if death is involved, the incident must also be reported to the FDA

clinical information systems

IT applications that support patient care delivery. Electronic medical records, for example, provide reliable information to guide clinical decision making and to produce timely reports on the quality of care delivered

clinical trial

a carefully designed research study in which human subjects participate under controlled observations. It is determined by using economic models that compare the benefits of a treatment to its costs.

Agency for Healthcare Research and Quality

a division of the department of health and human services; the lead federal agency charged with support research to improve the quality of healthcare, reduce health care costs, and improve access to essential services the agency's reports are available to medical practitioners, consumers, and other health care purchasers

tele-ICU

a relatively new development; it links intensivists and other critical care professionals to a system network that enables remote monitoring of ICUs. provides real-time patient assessment capabilities and communication with bedside teams through ongoing vital rounds -have shown lower patient mortality, shorter lengths of stay, and increased patient safety

magnetic resonance imaging

a technology that had its origins in basic research on structure of the atom has transformed into a major diagnostic tool

telemedicine

aka distant medicine; employs telecommunications technology for medical diagnosis and patient care when the provider and client are separated by distance also enables a generalist to consult a specialist when a patient's illness and diagnosis is complex

e-health

all forms of electronic health care delivered over the internet, ranging from informational, educational, and commercial "products" to direct services offered by professionals, non-professionals, businesses, or consumers themselves the use of this has grown as many providers have created secure internet portals to enable patients access to their EHRs; allow patient-provider email messaging; and use mobile app

food and drug administration

an agency of the US department of health and human services that is responsible for ensuring that drugs and medical devices are safe and effective for their intended use -they also control access to drugs by decide whether a certain drug will be available by prescription only or as an over the counter purchase

e-therapy

an alternative to face-to-face therapy for behavioral health support and counseling refers to professional therapeutic interactions online between qualified mental health professionals and their clients

informative technology

an integral part of health care delivery; involves computer applications that transform massive amounts of data into useful information. it is indispensable for managing the vast array of information that is used in patient care delivery, quality improvement, cost containment, billing and collections, and other aspects of operating health care organizations

Biologics Price Competition and Innovation Act of 2009

authorized the FDA to approve biosimilars under a process similar to the approval of generic drugs. Because of their complexity, the term generic cannot apply to biologics; hence, the term biosimilar

Prescription Drug User Fee Act of 1992

authorized the FDA to collect fees from pharmaceutical companies to review their drug applications. these fees have allowed the FDA to make new drugs available more quickly by shortening the time it takes for approval to be issued on the flip side, there has been an increasing trend in the number of prescription and over the counter drug recalls

telemedicine

based on integrated applications of telecommunications and information technologies

Elixir Sulfanilamide disaster

caused more than 100 deaths because of poisoning from a toxic solvent in the liquid preparation

Biologics

derived from living organisms and include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and therapeutic proteins that are indicated for the prevention or treatment of a disease or health condition -most are complex mixtures that are not easily identifiable or characterized FDA regulates their licensing under the Public Health Service Act of 1944; their safety and effectiveness is monitored under the FDC act of 1938

administrative information system

designed to assist in carrying out financial and administrative support activities such as payroll, patient accounting, staff scheduling, materials management, budgeting and cost control, and office automation

Class II

devices subject to requirements for labeling, performance standards, and postmakert surveillance. examples include powered wheelchairs and some pregnancy test kits

Class I

devices that pose the lowest risk and are generally simple in design. These devices are subject to general controls regarding misbranding, or fraudulent claims regarding their therapeutic effects. Examples include enema kits and elastic bandages.

orphan drug act of 1983

drug manufacturers are given incentives to produce new drugs for rare diseases passed as a result of pressure to find new drugs for the treatment of HIV as a result, certain new drug therapies, called orphan drugs, have become available for conditions that affect fewer than 200,000 people in the US

difference between e-health and e-therapy

e health is a self-help approach to obtaining web-based information whereas e-therapy is involves interaction with a health care professional

Food and Drug Modernization Act of 1997

fast-track approvals for life-saving drugs are permitted when their expected benefits exceed those of existing therapies

Cost effectiveness

goes a step beyond the determination of efficacy and safety by weighing benefits against costs. Optimal point is achieved when additional benefits equal the additional cost of treatment. Beyond the optimal point, additional interventions either deliver no further benefits or the cost of providing additional care begins to exceed the beenfts.

HIPAA 1996

health insurance portability and accountability act; restricted the legal use of personal medical information for three main purposes: -health care delivery to the patient -operation of the health care organization -reimbursement mandated strict controls over the transfer of personally identifiable health data between two entities, provisions for disclosure of protected information, and criminal penalties for violation also established certain patient rights, such as the right of patients to inspect and have copies of their protected health information, to request corrections to the records, and to restrict the use of the information

value

improved benefits at lower costs and health risks -its concept is becoming important to those who finance health care, including private employers, the government and managed care organizations -it can be increased by improving quality, reducing costs, or doing both

quality of life

indicates a patient's overall satisfaction with life during and after medical treatment. for example, it is enhanced when technology enables people to live normal lives despite disabling conditions affecting speech, hearing, vision, and movement

clinical decision support systems

interactive software systems designed to help clinicians with decision-making tasks, such as determining a diagnosis or recommending a treatment for a patient. use is not yet widespread internet and e health applications enable patients and practitioners to access information, facilitate interaction between consumers or between patients and providers, add certain conveniences for both physicians and patients, and enable the possibility of virtual visits

equipment and devices to render treatment

lithotripter heart and lung machine kidney dialysis machine pacemaker

facilities and organizational systems

medical centers and systems laboratories managed care networks health information systems patient care management e-health and e-therapy telemedicine distance education electronic medical records

major changes triggered by technology

new technology has raised consumer expectations about what may be possible. technology influences the organization and financing of medical services the introduction of advanced technology has influenced the scope and content of medical training. Also, there has been an excess of specialists at the expense of PCP, public health, and preventative medicine. As a whole technology has contributed to health care cost escalation. Technology has raised complex moral and ethical dilemmas in medical research and decision making.

medical procedures

open-heart surgery tissue transplants hip and knee replacements

the biosimilar user fee act of 2012

passed subsequent to the ACA, authorized the FDA to charge biopharmaceutical firms a user fee to pay for the review of applications for biosimilar products

Medical Devices Amendment

premarket review of medical devices is authorized; devices are grouped into 3 classes

Criteria for quality of care

prevent or delay disease onset provide a more accurate diagnosis that is possible with currently available options provide a quicker cure provide a more complete cure increase safety or treatment minimize side effects provide for faster recovery from surgery increase life expectancy add to quality of life

decision support systems

provide information and analytical tools to support managerial decision making. Such tools are used to forecast patient volume, project staffing requirements, evaluate financial performance, analyze utilization, conduct clinical research, and improve quality and productivity

Safety

refers to protection against unnecessary harm from the use of technology.

meaningful use

refers to specific criteria in quality, safety, efficiency, etc that providers are required to meet

health technology assessment

refers to the evaluation of medical technology to determine its efficacy, safety, and cost-effectiveness. -it also informs various stakeholders about the ethical, legal, and social implications of medical technologies -the objective is to establish the appropriateness of medical technology for widespread use -becomes essential because many technologies have not produced health benefits; some may even be harmful. It governs decisions to adopt and disseminate new technology

efficiencies brought by use of internet

register patients direct them to alternative care sites transmit diagnostic results order pharmaceuticals and other products

electronic health records

replaced the traditional paper medical records; the use of them in health delivery organizations is well under way, but little progress has been made in the development of information sharing networks they make it possible to access individual records online from many separate, interoperable automated systems within an electronic network

Federal Food, Drug, and Cosmetic Act of 1938

strengthened the Food and Drugs Act of 1906; passed in response to the Elixir Sulfanilamide disaster. **Under the law, drug manufacturers were required to provide scientific evidence about the safety of new products before putting them on the market.

medical practice guidelines

systematically developed protocols to assist practitioners in delivering appropriate health care for specific clinical circumstances.

biosimilar

term created to apply to products that are highly similar to, or are interchangeable with, an already approved biological product believed that their introduction will create competition and drive down the cost of biologics -first of this kind of product to be approved in the US in March 2015 was Zarxio, similar to Neupogen which can be prescribed for the treatment of certain cancers

Food and Drugs Act of 1906

the Bureau of Chemistry was authorized to take action only after drugs had been marketed to consumers. It was assumed that the manufacturer would conduct safety tests before marketing the product. If innocent consumers were harmed, only then could the FDA take action.

interoperability

the ability to share and access patient information by various users

technological imperative

the desire to have state-of-the-art technology available, accompanied by the desire to use it despite its cost

technology diffusion

the development and dissemination of technology this factor determines which new technology will be developed, when it will be made available for use, and where it can be accessed

nanomedicine

the emerging area of medical technology that requires manipulation of materials at the atomic and molecular levels. scientists are working on the use of nano materials for accurate diagnosis and treatment of diseases, such as cancer

Efficacy

the health benefit to be derived from the use of technology, or how effective a given technology is in diagnosing or treating a condition

medical technology

the practical application of scientific knowledge to improve people's health and to create efficiencies in the delivery of medical care

health informatics

the term now used for IT applications that are designed to improve clinical efficiency, accuracy, and reliability