Policies, Guidelines, and Laws in Nursing Informatics

Privacy Act of 1974

It regulates information collected by the federal government and its agencies.

Privacy Act of 1974

The legislation allow citizens to know what information is collected about them, assure the veracity of that data and obtain copies of the information.

The Veterans Health Administration and Indian Health Services

These are subject to the regulations of Privacy Act of 1974.

Alcohol and Drug Abuse Patient Confidentiality

Confidentiality of Alcohol and Drug Abuse Patient Records rule allows for additional privacy in any federally-assisted drug or alcohol abuse program. Identity, diagnosis, and treatment are treated as confidential information.

Patient impairment

____________ does not excuse the release of confidential patient information.

Conditions for Coverage of Specialized Services by Suppliers

It is part of Medicare laws that govern providers and requires that all PHI be kept confidential and protected against loss, destruction, or unauthorized use.

Conditions for Coverage of Specialized Services by Suppliers

This information requires the written approval of the patient before it is used or forwarded. Hospital must protect this information against unauthorized use and current EHR allow for monitoring and securing data.

Conditions for Coverage of Specialized Services by Suppliers

Patient always have a right to access their records; an institution is allowed to charge a usual and customary fee for paper copy cost. These laws extend to home health agencies and long term care facilities.

Institutional Review Board

It is governed by state and federal laws and require informed written consent and data security and privacy.

Joint Commission on Accreditation of Healthcare Organizations

It is a private organization that has been used since 1965 to accredit hospital and facilities, which allowed for their participation in Medicare.

Centers for Medicare and Medicaid Services (CMS)

In JCAHO, during 2010, the process changed to provide for review by ______ to facility participation.

Joint Commission on Accreditation of Healthcare Organizations

______ has had varying abilities to control and determine rules related to patient care, several of which pertain to PHI confidentiality.

Health Information Technology for Economic and Clinical Health Act of 2009

It empowers the Federal Department of Health and Human Services (HHS) to oversee the promotion of Health IT- including quality, safety, and security as well as the secure information exchange.

Health Insurance Portability and Accountability Act of 1996

It is enacted to allow for the cont=inuance of health insurance coverage in situations involving job changes or loss.

Health Insurance Portability and Accountability Act of 1996

Major provisions of this law were enacted to formulate and regulate federal guidelines and standards pertaining to electronic healthcare.

National Provider Identifier Standard (NPIS)

It provides every physician with a unique number used in all aspects of healthcare.

Affordable Care Act of 2010

It set up to fundamentally change the way people are insured.

Affordable Care Act of 2010

The goals include lowering healthcare costs and making coverage accessible to previously uninsured people.

Affordable Care Act of 2010

This law is undergoing major changes as issues with its implementation are encountered.

Food and Drug Administration Safety and Innovation Act of 2012

This resulted in the collaboration of the HHS and FDA to recommend a regulatory framework for Health IT to improve mobile applications and other means to promote patient safety and innovation in healthcare delivery.

Food and Drug Administration Safety and Innovation Act of 2012

Familiarity with these laws and their implications is paramount for improved functioning in the promotion and development of computer-based patient-care systems.

Medicare Access & CHIP (Children's Health Insurance Program) Reauthorization Act of 2015

It is intended to ensure that physicians are paid fairly, that Medicare Part B costs are controlled, and that healthcare is improved.

21st Century Cures Act

It is passed by both houses of Congress and signed into law by President Obama in December 2016.

21st Century Cures Act

It covers many facets of healthcare The goals for all, though, are the same: to "help modernize and personalize health care, encourage greater innovation, support research, and streamline the system," according to the act's mission statement.

Intellectual Property law

deals with laws to protect and enforce rights of the creators and owners of inventions, writing, music, designs and other works, known as the "intellectual property."

Intellectual property (IP)

The creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.

Copyright (Author's right)

legal term used to describe the rights that creators have over their literary and artistic works.

expressions, and not to ideas, procedures, methods of operation or mathematical concepts as such.

Copyright protection extends only to _________.

objects such as titles, slogans, or logos, depending on whether they contain sufficient authorship

Copyright may or may not be available for a number of ________.

Economic rights

allow the rights owner to derive financial reward from the use of their works by others

Moral rights

protect the non-economic interests of the author

Reproduction, public performance, recording, broadcasting, and adaptation

Example of economic rights.

The right to claim authorship of a work and the right to oppose changes to a work that could harm the creator's reputation.

Example of moral rights.

without

copyright protection is obtained automatically ______ the need for registration or other formalities.

Voluntary registration systems

It can help solve disputes over ownership or creation, as well as facilitate financial transactions, sales, and the assignment and/or transfer of rights.

WIPO PROOF

Using _________ complements voluntary copyright registration systems by offering creators the possibility of recording and digitally certifying possession of the work.

Patent

an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.

patent

To get a _______, technical information about the invention must be disclosed to the public in a patent application.

territorial rights

Patents are ________. In general, the exclusive rights are only applicable in the country or region in which a patent has been filed and granted, in accordance with the law of that country or region.

20 years

The protection is granted for a limited period, generally _____ from the filing date of the application.

trademark

a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises

National/regional level

trademark protection can be obtained through registration, by filing an application for registration with the national/regional trademark office and paying the required fees

International level

2 options: either you can file a trademark application with the trademark office of each country in which you are seeking protection, or you can use WIPO's Madrid System.

10 years

The term of trademark registration can vary, but it usually last ____.

private rights

Trademark rights are ______ and protection is enforced through court orders.

Industrial Design

in a legal sense, it constitutes the ornamental aspect of an article

Industrial Design

It may consist of three dimensional features, such as the shape of an article, or two dimensional features, such as patterns, lines or color.

registered design

In most countries, an industrial design needs to be registered in order to be protected under industrial design law as a "_____"

design patents

In some countries, industrial designs are protected under patent law as "______ ".

unregistered industrial designs

Industrial design laws in some countries grant without registration time and scope limited protection to so called "___________".

works of art

Depending on the particular national law and the kind of design, industrial designs may also be protected as _________ under copyright law.

Geographical indication (GI)

sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin

Geographical indications

typically used for agricultural products, foodstuffs, wine and spirit drinks, handicrafts, and industrial products.

sui generis systems (i.e. special regimes of protection)

using collective or certification marks

methods focusing on business practices, including administrative product approval schemes

unfair competition laws

4 main ways to protect the geographical indication

sui generis systems and collective or certification mark systems

They share some common features, such as the fact that they set up rights for collective use by those who comply with defined standards.

Geographical indication

defined in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and in the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications.

Appellation of origin

defined in the Lisbon Agreement for the Protection of Appellations of Origin and their International Registration and in the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications.

Protected Designation of Origin (PDO) and Protected Geographical Indication (PGI)

terms used within the European Union.

Trade secrets

intellectual property (IP) rights on confidential information which may be sold or licensed

commercially valuable because it is secret

be known only to a limited group of persons

subject to reasonable steps taken by the rightful holder of the information to keep it secret, including the use of confidentiality agreements for business partners and employees.

What qualifies as a trade secret?

technical information

information concerning manufacturing processes, pharmaceutical test data, designs and drawings of computer programs

commercial information

distribution methods, list of suppliers and clients, and advertising strategies.

combination of elements

A trade secret may be also made up of a _____, each of which by itself is in the public domain, but where the combination, which is kept secret, provides a competitive advantage.

unfair competition or is based on specific provisions or case law on the protection of confidential information.

Depending on the legal system, the legal protection of business secrets forms part of the general concept of protection against _________

industrial or commercial espionage, breach of contract and breach of confidence

While a final determination of whether trade secret protection is violated or not depends on the circumstances of each individual case, in general, unfair practices in respect of secret information include ____.

Non-disclosure agreement (NDA)

employees and business partners should sign a non-disclosure agreement that prevent them from disclosing a company's confidential information.

Non-compete agreement (NCA)

employers should ask employees, contractors and consultants to sign a non-compete agreement to prevent them from entering in competition when their employment/service agreement ends.

RA 8293

An Act prescribing the Intellectual Property Code and establishing the Intellectual Property Office, providing for its powers and functions, and for other purposes

RA 165

An Act creating a patent office, prescribing its powers and duties, regulating the issuance of patents, and appropriating funds therefore

RA 166

An Act to provide for the registration and protection of trade-marks, trade-names, and service marks, defining unfair competition and false marking and providing remedies against the same, and for other purposes.

Presidential Decree no. 49

Decree on the protection of intellectual property

RA 8293

The Intellectual Property Code

RA's 9150, 9502, 10372

The Intellectual Property Code, as amended by:

Memorandum Circular No. 17-013

The Revised Implementing Rules and Regulations (IRR) for Patents, Utility Models and Industrial Designs recently amended by:

Copyright Law

a form of intellectual property law, protects original works of authorship including literary, dramatic, musical, and artistic works, such as poetry, novels, movies, songs, computer software, and architecture.

Copyright

a collection of all rights enjoyed by the owner of an artistic or literary work

Derivative works

may include: dramatizations, translations, adaptations, abridgements, arrangements, and other alterations of literary music work; collections of literary, scholarly or artistic works, and compilations of data and other materials which are original by reason of the selection or coordination or arrangement of their contents.

during the lifetime of the author 50+ years after the author's death

In the Philippines, copyright protection for artistic, literary and derivative works lasts ___________.

50 years from the date on which the work was first lawfully published

In case of anonymous or pseudonymous works, copyright protection shall last for _________.

50 years counted from the creation of the work.

If the work was not published, it shall be protected for ________.

25 years from the date of its creation

Works of applied art shall be protected for ______.

50 years from the date of publication

Audio-visual works shall be protected for ___________.

50 years from the end of the year in which the performance took place

Performances not incorporated in recordings shall be protected for ________.

50 years from the end of the year in which the recording took place

Sound or image and sound recordings and performances incorporated therein shall be protected for ____________.

20 years

Broadcasts shall be protected for _______ from the date the broadcast took place.

Decompilation

reproduction of the code and translation of the forms of the computer program to achieve the inter-operability of an independently created computer program with other programs constitutes fair use and is allowed

Optical Media Act of 2003

regulates the manufacture, mastering, replication, importation and exportation of optical media in which information, including sounds and/or images, or software code, has been stored, either by mastering and/or replication

fair use

multiple copies for classroom use, scholarship, research and similar purposes which is not an infringement of copyright.

Copyright infringement

reproduction, distribution, performance, and public display of copyright protected material without the permission of the copyright holder.

Counterfeit

goods, including packaging, bearing w/o authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark.

Patent infri

occurs when another party makes, uses, or sells a patented item without the permission of the patent holder.

Trademark

Unauthorized use of a trademark or service mark on or in connection with goods and/or services in a manner that is likely to cause confusion, deception, or mistake about the source of the goods and/or services.

criminal case

A ______ for copyright infringement must be filed in the court situated in the place where the violation occurred.

administrative suit

The _____ is filed at the Bureau of Legal Affairs at the Intellectual Property Office of the Philippines.

civil infringement lawsuit

A __________ is filed in the appropriate court located at the place where the defendant resides/is located, or where the plaintiff resides/is located, at the option of the plaintiff.

Imprisonment of between 1 to 3 years and a fine of between 50,000 to 150,000 pesos

Penalty for first offense of copyright infringement

Imprisonment of 3 years and 1 day to six years plus a fine of between 150,000 to 500,000 pesos

Penalty for second offense of copyright infringement

Imprisonment of 6 years and 1 day to 9 years plus a fine ranging from 500,000 to 1,500,000 pesos

Penalty for third offense of copyright infringement

Privacy policy watchdog groups

believe that the biggest challenge may be that technology seems to develop at the speed of light, while the legal protection of personal privacy moves at the speed of legislators.

Netiquette

refers to the socially acceptable rules of online conduct; a portmanteau of net and etiquette.