Medical Technology (MT) Laws: A. Basic Concepts
Medical Technology (MT) Laws: A. Basic Concepts
Objectives:
At the end of this lecture, the student should be able to:
1. identify the basic significance of the law;
2. trace the relationship of the laws and rules concerning the medical technology profession;
3. describe the importance of learning ethics and the principles behind it;
4. be acquainted with the basic principles of privacy with respect to the Data Privacy Act of 2012;
and,
5. refresh and solidify his/her basic knowledge on Medical Technology Laws and Bioethics;
A. BASIC CONCEPTS
1. Law
A rule of conduct, promulgated by legitimate authority (typically by the Legislature), which are
just and obligatory for common observance and benefit.1
2. Statute
A law passed by a legislative body (congress).2
1
Jurado, D.P. Civil Law Reviewer.
2
Black’s Law Dictionary
3
EXECUTIVE ORDER NO. 292
Chapter 11. Administrative Issuances
Section 50. General Classification of Issuances. - The administrative issuances of Secretaries and heads of
bureaus, offices or agencies shall be in the form of circulars or orders.
(1) Circulars shall refer to issuances prescribing policies, rules and regulations, and procedures
promulgated pursuant to law, applicable to individuals and organizations outside the Government and
designed to supplement provisions of the law or to provide means for carrying them out, including
information relating thereto; and
(2) Orders shall refer to issuances directed to particular offices, officials, or employees, concerning
specific matters including assignments, detail and transfer of personnel, for observance or compliance
by all concerned.
SECTION 3. Administrative Orders.—Acts of the President which relate to particular aspects of governmental
operations in pursuance of his duties as administrative head shall be promulgated in administrative orders.
SECTION 4. Proclamations.—Acts of the President fixing a date or declaring a status or condition of public
moment or interest, upon the existence of which the operation of a specific law or regulation is made to
depend, shall be promulgated in proclamations which shall have the force of an executive order.
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Rules, policies, or guidelines issued by administrative bodies to implement the law. <Take note
in particular the issuances of the Department of Health (DOH), Commission on Higher Education
(CHED) and Professional Regulation Commission (PRC).>
5. Repeal
Abrogation of an existing law by legislative act. 5
6. Amendment
a. To make right; to correct or rectify.
b. To change the wording of; specif., to formally alter (a statute, constitution, motion, etc.) by
striking out, inserting, or substituting words. 6
7. Revision
a) A reexamination or careful review for correction or improvement.
b) revised statutes. Laws that have been collected, arranged, and reenacted as a whole by a
legislative body.7
Such statement is better explained by Aristotle, he stated that: “… the law having laid down
the best rules possible, leaves the adjustment and application of particulars to the discretion
of the magistrate; besides, it allows anything to be altered which experience proves may be
better established. Moreover, he who would place the supreme power in mind, would place it
SECTION 7. General or Special Orders.—Acts and commands of the President in his capacity as Commander-
in-Chief of the Armed Forces of the Philippines shall be issued as general or special orders.
4
Civil Code of the Philippines (RA 386). Article 8.
5
Black’s Law Dictionary.
6
Id.
7
Id
8
A famous phrase by John Adams, one of the founding fathers of the United States.
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in God and the laws; but he who entrusts man with it, gives it to a wild beast, for such his
appetites sometimes make him; for passion influences those who are in power, even the very
best of men: for which reason law is reason without desire.”9
B. MT EDUCATION
Created as independent and separate from the Department of Education, Culture and Sports
(DECS), and attached to the Office of the President for administrative purposes only.
Its covers both public and private institutions of higher education as well as degree-granting
programs in all post-secondary educational institutions, public and private. (sec. 3)
One of its primary functions is to formulate and recommend development plans, policies,
priorities, and programs on higher education and research; (sec. 8)
"It is the business of a university to provide that atmosphere which is most conducive to
speculation, experiment and creation. It is an atmosphere in which there prevail 'the four
essential freedoms' of a university to determine for itself on academic grounds who may teach,
what may be taught, how it shall be taught, and who may be admitted to study."11
Degree Name:
Bachelor of Science in Medical Technology/Bachelor of Science in Medical Laboratory Science
9
Aristotle: A Treatise on Government. Book III, Chapter XVI.
10
Article 3. RA 386
11
Justice Frankfurter, concurring in Sweezy v. New Hampshire, 364 US 234, 263 (1957). Adopted by the Supreme
Court in the case of Garcia v. Loyola School of Theology (G.R. No. L-40779 | 1975-11-28).
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Bachelor of Science in Medical Technology/ Bachelor of Science in Medical Laboratory Science
(BSMT/BSMLS) is a four-year program consisting of general education and professional
courses. The fourth-year level is the internship program of one year in a CHED-accredited
training laboratory with rotational duties in different sections such as Clinical Chemistry,
Hematology, Microbiology, Immunohematology, Immunology and Serology, Urinalysis and
other Body Fluids, Parasitology, Histopathologic/Cytologic Techniques, and other emergent
technologies. (sec. 5)
2. The Curriculum
HEIs offering Medical Technology/ Medical Laboratory Science Education may exercise
flexibility in their curricular offering. However, Medical Technology/ Medical Laboratory
Science courses as prescribed in the sample program shall be implemented. (sec. 5, please
refer to CMO No. 13 s. 2017 for the details)
3. Internship Guidelines
C. MT PROFESSION
1. BOARD EXAMINATION
RA 5527: Philippine Medical Technology Act of 1969
a. Nature of Examination
All applicants for registration as medical technologist shall be required to undergo written
examination which shall be given by the Board annually in the greater Manila area, Cebu, and
Davao during the month of August or September on such days and places as the Board may
designate. (sec. 15)
c. Scope of Examination
The examination questions shall cover the following subjects with their respective relative
weights: (sec. 17)
Clinical Chemistry ...................................................... 20%
Microbiology & Parasitology ...................................... 20%
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Hematology ............................................................... 20%
Blood Banking & Serology ......................................... 20%
Clinical Microscopy (Urinalysis and
other body fluids) ...................................………......... 10%
Histopathologic Techniques,
Cytotechnology, Medical
Technology Laws, Related
Laws and its implementing
rules, and the Code of Ethics ........................……….. 10%
The Board may change, add to or remove from the list of subjects or weights above as progress
in the science of Medical Technology may require, subject to the prior approval of the
Professional Regulation Commission, and publication of the change or amendment at least
three (3) months prior to the date of examination in which the same is to take effect.
No further examination will be given an applicant who has not qualified after three
examinations, unless and until he shall have completed 12 months refresher course in an
accredited medical technology school or 12-month postgraduate training in an accredited
laboratory. (sec. 19)
e. Oath Taking
All successful examinees shall be required to take a professional oath before the Board or
before any person authorized to administer oaths prior to entering upon the practice of
medical technology in the Philippines. (sec. 20)
2. MT PRACTICE
a. RA 5527
Medical Technologist is a person who engages in the work of medical technology under the
supervision of a pathologist or licensed physician authorized by the department of health in
places where there is no pathologist. (sec. 2.a)
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be entitled to be represented by counsel or be heard in person, to have a speedy and public
hearing, to confront and cross-examine witnesses against him or her, and to all other rights
guaranteed by the Constitution.
The Board may, after giving proper notice and hearing to the party concerned reprimand an
erring medical technologist or
1. any guilty of immoral or dishonorable
2. for unprofessional conduct,
3. malpractice,
4. incompetency, or
5. serious ignorance or
6. gross negligence in the practice of medical technology.
The penalty of revocation shall be imposed only if there is a unanimous vote of all the three
members of the Board.
The Board may, by majority vote, impose the penalty or reprimand or suspension.
Effect of Revocation/Suspension:
When the penalty of suspension or revocation is imposed by the Board the medical
technologist shall be required to surrender his certificate of registration within thirty days after
the decision becomes final, under the pain of perpetual disqualification from the practice of
medical technology in the Philippines for inexcusable failure to do so.
Rationale: To promote and upgrade the practice of professions in the country. Towards this
end, the State shall institute measures that will continuously improve the competence of the
professionals in accordance with the international standards of practice, thereby, ensuring
their contribution in uplifting the general welfare, economic growth and development of the
nation.
The CPD is a mandatory requirement in the renewal of the PICs of all registered and licensed
professionals under the regulation of the PRC. (sec. 10)
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Annex J. List of CPD Programs and their respective equivalent units. (Annex C)
3. informal learning: refers to learning that occurs in daily life assessed through
recognition, validation and accreditation process which can contribute to a
qualification;
45 credit units within 3 years is required for the renewal of a PRC license.12
Undertaking for the renewal in lieu of actual renewal of PIC is extended until December 31,
2022, pursuant to PRC Resolution No. 1444(A) s. 2021.
3. Workplace
Clinical Laboratory
A laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings
or animals are analyzed for the determination of the presence of pathologic organisms,
processes and/or conditions in the persons or animals from which they were obtained. (sec. 1)
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*Relate the above provision with RA 552713 which describes a Medical Technologist as
a person who engages in the work of medical technology under the supervision of a
pathologist or licensed physician authorized by the department of health in places
where there is no pathologist.
2. Garcia, who is a medical technologist, conducted the HBs Ag (Hepatitis B Surface Antigen)
test and on October 22, 1993, CDC issued the test result5 indicating that Ranida was "HBs Ag:
Reactive."
3. The result bore the name and signature of Garcia as examiner and the rubber stamp
signature of Castro as pathologist.
4. Ranida submitted the test result to Dr. Sto. Domingo, the Company physician, the latter
apprised her that the findings indicated that she is suffering from Hepatitis B, a liver disease.
5. Based on the medical report submitted by Sto. Domingo, the Company terminated Ranida’s
employment for failing the physical examination.
6. When Ranida informed her father, Ramon, about her ailment, the latter suffered a heart
attack and was confined at the Bataan Doctors Hospital.
7. Ranida underwent another HBs Ag test at the said hospital and the result indicated that she
is non-reactive. She informed Sto. Domingo of this development but was told that the test
conducted by CDC was more reliable because it used the Micro-Elisa Method. Thus, Ranida
went back to CDC for confirmatory testing, and this time, the Anti-HBs test conducted on her
indicated a "Negative" result.
8. Ranida also underwent another HBs Ag test at the Bataan Doctors Hospital using the Micro-
Elisa Method. The result indicated that she was non-reactive.
9. Ranida submitted the test results from Bataan Doctors Hospital and CDC to the Executive
Officer of the Company who requested her to undergo another similar test before her re-
employment would be considered. Thus, CDC conducted another HBs Ag test on Ranida which
indicated a "Negative" result.
13
Section 2(a).
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10. Ma. Ruby G. Calderon, Med-Tech Officer-in-Charge of CDC, issued a Certification correcting
the initial result and explaining that the examining medical technologist (Garcia) interpreted
the delayed reaction as positive or reactive.
“It is clear that a clinical laboratory must be administered, directed and supervised by a
licensed physician authorized by the Secretary of Health, like a pathologist who is
specially trained in methods of laboratory medicine; that the medical technologist must
be under the supervision of the pathologist or a licensed physician; and that the results
of any examination may be released only to the requesting physician or his authorized
representative upon the direction of the laboratory pathologist.”
** Castro claimed that as pathologist, he rarely went to CDC and only when a case was
referred to him; that he did not examine Ranida; and that the test results bore only his
rubber-stamp signature.
Art. 20. Every person who, contrary to law, willfully or negligently causes damage to
another, shall indemnify the latter for the same.
DOH AO 2021-0037: The latest rules and regulations for Clinical Laboratory
The head of the laboratory shall visit once a month and at least twice a week of supervisory
calls and/or videoconferencing OR at least once a week physical visit. For hospital-based DOH
licensed CL, it shall be once a week physical visit. The visits shall have to be well documented.14
(** relate this with the case of Garcia)
14
Annex A. II. A.4
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D. OTHER RELATED LAWS
In addition, violators of RA 9165 shall also undergo mandatory drug testing. (sec. 38)
Screening Test refers to a test to eliminate negative specimen from further consideration and
to identify the presumptively positive specimen that requires confirmatory testing. 15
Confirmatory Test refers to the analytical procedure to identify and quantify the presence of
a specific drug or metabolite, which is independent of the initial test and which uses a different
technique and chemical principle from that of the screening test in order to ensure reliability
and accuracy.16
Validity of Drug test certificates. It shall be valid for a one-year period from the date of issue
which may be used for other purposes
SJS v. DDB (G.R. No. 157870, November 3, 2008); Laserna v. DDB (G.R. No. 158633, November
3, 2008); Pimentel v. COMELEC (G.R. No. 161658, November 3, 2008)
Significance: determination of the validity of the enumerated items for authorized drug testing
under sec. 36 of RA 9165
15
Section 3. DDB Board Regulation No. 2, series of 2003.
16
Id.
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This is a consolidation of cases questioning the validity of authorized drug testing with
respect to Sec. 36[c], [d], [f], and [g] of RA 9165.
N.B.: RA 10586 or the “Anti-Drunk and Drugged Driving Act of 2013” repealed Section
36 (a) of RA 9165.
Beltran v. Secretary of Health (G.R. No. 133640 and G.R. No. 139147 | 2005-11-25)
Significance: history of blood banking and blood donation; the principle of voluntary donation in
this case is also applicable to organ donation
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The phasing out commercial blood bank is valid and reasonable. The law enacted is a valid
exercise of the Police Power of the state: the power to promote the general welfare through
the promotion of public health.
Factual bases:
1. In 1979, there arose the intensified international concern for the safety of blood and
blood products intensified when the dreaded disease Acute Immune Deficiency
Syndrome (AIDS) was first described. In 1982, the first case of transfusion-associated
AIDS was described in an infant.
2. In January of 1994, the New Tropical Medicine Foundation, with the assistance of the
U.S. Agency for International Development (USAID) released its final report of a study
on the Philippine blood banking system entitled "Project to Evaluate the Safety of the
Philippine Blood Banking System. The following are the results:
a. It was revealed that of the blood units collected in 1992, 64.4 % were supplied by
commercial blood banks, 14.5% by the PNRC, 13.7% by government hospital-based
blood banks, and 7.4% by private hospital-based blood banks.
The study deduced that each commercial blood bank produces five times more
blood than the Red Cross and fifteen times more than the government-run blood
banks; the Philippines heavily relied on commercial sources of blood. The study
likewise revealed that 99.6% of the donors of commercial blood banks and 77.0%
of the donors of private-hospital based blood banks are paid donors. Paid donors
are those who receive remuneration for donating their blood. Blood donors of the
PNRC and government-run hospitals, on the other hand, are mostly voluntary
b. It was further found, among other things, that blood sold by persons to blood
commercial banks are three times more likely to have any of the four (4) tested
infections or blood transfusion transmissible diseases, namely, malaria, syphilis,
Hepatitis B and Acquired Immune Deficiency Syndrome (AIDS) than those donated
to PNRC.
Commercial blood banks give paid donors varying rates around ₱50 to ₱150, and
because of this arrangement, many of these donors are poor, and often they are
students, who need cash immediately. Since they need the money, these donors
are not usually honest about their medical or social history. Thus, blood from
healthy, voluntary donors who give their true medical and social history are about
three times much safer than blood from paid donors.
3. REPUBLIC ACT No. 11166: Philippine HIV and AIDS Policy Act
PNAC Resolution No. 1 (IRR)
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How? There must be written consent as evidenced by the signature or a thumbmark as the
case may be from the person taking the test must be obtained before HIV testing.
1. If the person is fifteen (15) to below eighteen (18) years of age, consent to
voluntary HIV testing shall be obtained from the child without the need for the
consent of a parent or guardian.
2. Any person age below fifteen (15) years, who is pregnant or engaged in high-risk
behavior, shall be eligible for HIV testing and counseling with the assistance of
licensed social worker or health worker. Consent to voluntary HIV testing shall be
obtained from the child without the need for the consent of a parent or guardian.
(“mature minor doctrine”)
3. In all other cases not covered by paragraph (b) of this section, consent to
voluntary HIV testing shall be obtained from the child’s parents or legal guardian if
the person is below fifteen (15) years of age or is mentally incapacitated.
In cases when the child’s parents or legal guardian cannot be located despite reasonable
efforts, or if the child’s parents or legal guardian refuse to give consent, it shall be obtained
from the licensed social worker or health worker. To protect the best interest of the child,
the assent of the minor shall also be required prior to the HIV testing.
b) When it is necessary to resolve relevant issues under Executive Order No. 209,
otherwise known as “The Family Code of the Philippines’; and
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(c) All donors whose blood, organ or tissue has been tested positive shall be deferred from
donation, notified of their HIV status, counselled, and referred for care and clinical
management as soon as possible;
(d) Donations of blood, tissue, or organ testing positive for HIV may be accepted for
research purposes only, and shall be subject to strict sanitary disposal requirements; and
(e) A second testing may be demanded as a matter of right by the blood, tissue, or organ
recipient or his/her immediate relatives before transfusion or transplant, except during
emergency cases.
(a) A person volunteers or freely agrees to donate one's blood, organ, or tissue for
transfusion, transplantation, or research; and
(b) A legacy and a donation are executed in accordance with Sections 3 and 4
respectively, of Republic Act No. 7170, otherwise known as the "Organ Donation
Act of 1991".
*The law provides for a presumption of consent for donated organs but remember that
the process of testing itself requires informed consent
c. Duty of Confidentiality
General Rule:
The confidentiality and privacy of any individual, who has been tested for HIV, has been
exposed to HIV, has HIV infection or HIV-AIDS related illnesses, or was treated for HIV
related illnesses shall be guaranteed
Exceptions:
a) When complying with reportorial requirements of the national active and
passive surveillance system, including reports of death, of the DOH: Provided, that
the information related to a person’s identity shall remain confidential;
b) When informing other health workers directly involved in the treatment or care
of a PLHIV: Provided, that such workers shall be required to perform the duty of
shared medical confidentiality; and
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Provided, further, That the judicial or administrative proceedings shall be held in
executive session.
Discrimination against persons with HIV is prohibited and is punishable under the law.
Personal information controller refers to a person or organization who controls the collection,
holding, processing or use of personal information, including a person or organization who
instructs another person or organization to collect, hold, process, use, transfer or disclose
personal information on his or her behalf. (Sec. 3.h.)
Personal information refers to any information whether recorded in a material form or not, from
which the identity of an individual is apparent or can be reasonably and directly ascertained by the
entity holding the information, or when put together with other information would directly and
certainly identify an individual. (Sec. 3.g.)
(1) About an individual’s race, ethnic origin, marital status, age, color, and religious,
philosophical or political affiliations;
(2) About an individual’s health, education, genetic or sexual life of a person, or to any
proceeding for any offense committed or alleged to have been committed by such person,
the disposal of such proceedings, or the sentence of any court in such proceedings;
(3) Issued by government agencies peculiar to an individual which includes, but not limited
to, social security numbers, previous or current health records, licenses or its denials,
suspension or revocation, and tax returns; and
17
sec. 3(h). RA 11166.
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(4) Specifically established by an executive order or an act of Congress to be kept
classified.
Processing refers to any operation or any set of operations performed upon personal information
including, but not limited to, the collection, recording, organization, storage, updating or
modification, retrieval, consultation, use, consolidation, blocking, erasure or destruction of data.
(Sec. 3.j.)
Principles to Remember:18
The processing of personal data shall be allowed subject to adherence to the following principles:
a. Transparency. The data subject must be aware of the nature, purpose, and extent of the
processing of his or her personal data, including the risks and safeguards involved, the identity
of personal information controller, his or her rights as a data subject, and how these can be
exercised. Any information and communication relating to the processing of personal data
should be easy to access and understand, using clear and plain language.
b. Legitimate purpose. The processing of information shall be compatible with a declared and
specified purpose which must not be contrary to law, morals, or public policy.
18
Sec. 18. Rule IV. IRR of
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BIOETHICS
Ethics
At its simplest, ethics is a system of moral principles. They affect how people make decisions and lead
their lives. Ethics is concerned with what is good for individuals and society and is also described as
moral philosophy.
Bioethics
Bioethics provides a disciplinary framework for the whole array of moral questions and issues
surrounding the life sciences concerning human beings, animals, and nature. The notion of bioethics
is commonly understood as a generic term for three main sub-disciplines: medical ethics, animal ethics,
and environmental ethics. Each sub-discipline has its own particular area of bioethics, but there is a
significant overlap of many issues, ethical approaches, concepts, and moral considerations. 19
(hyperlinked)
1. Autonomy
It requires that the patient have autonomy of thought, intention, and action when making
decisions regarding health care procedures. Therefore, the decision-making process must be free
of coercion or coaxing. In order for a patient to make a fully informed decision, she/he must
understand all risks and benefits of the procedure and the likelihood of success.
This principle also embodies the principle of respect and informed consent.
2. Justice
19
Bioethics | Internet Encyclopedia of Philosophy (utm.edu)
20
Medical Ethics 101 (stanford.edu); Principles of Bioethics | UW Department of Bioethics & Humanities
(washington.edu)
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Justice in health care is usually defined as a form of fairness, or as Aristotle once said,
"giving to each that which is his due." It is the idea that the burdens and benefits of new or
experimental treatments must be distributed equally among all groups in society. Moreover, it
requires that procedures uphold the spirit of existing laws and are fair to all players involved. The
health care provider must consider four main areas when evaluating justice: fair distribution of
scarce resources, competing needs, rights and obligations, and potential conflicts with established
legislation.
3. Beneficence
It requires that the procedure be provided with the intent of doing good for the patient
involved. The ordinary meaning of this principle is that health care providers have a duty to be of
a benefit to the patient, as well as to take positive steps to prevent and to remove harm from the
patient.
4. Non-maleficence
It requires that a procedure should not harm the patient involved or others in society. The
principle of nonmaleficence requires of us not to intentionally create a harm or injury to the
patient, either through acts of commission or omission.
N.B. In the determination of morality of a certain conduct through the application of these
principles, the totality of circumstances must be considered. Some of the factors involved are: the
perspectives of the health professional, the patient, and other persons directly involved, and the
cause and effect of the conduct of the health professionals. As such, it is common for the
overlapping of the principles to ensue.
As I enter into the practice of Medical Technology, I shall accept the responsibilities inherent to being
a professional; I shall uphold the law and shall not engage in illegal work nor cooperate with anyone
so engaged; I shall avoid associating or being identified with any enterprise of questionable character;
I shall work and act in a strict spirit of fairness to employer, clients, contractors, employees and in a
spirit of personal helpfulness and fraternity toward other members of the profession;
I shall use only honorable means of competition for professional employment or services and shall
refrain from unfairly injuring, directly or indirectly, the professional reputation, projects or business of
a fellow medical technologist; I shall accept employment from more than one employer only when
there is no conflict of interest;
I shall perform professional work in a manner that merits full confidence and trust carried out with
absolute reliability, accuracy, fairness and honesty; I shall review the professional work of other
medical technologists, when requested, fairly and in confidence whether they are subordinates or
employees, authors of proposals for grants or contracts, authors of technical papers or other
publications or involved in litigation;
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I shall advance the profession by exchanging general information and experience with fellow medical
technologists and other professionals and by contributing to the work of professional organizations;
I shall restrict my praises, criticisms, views and opinions within constructive limits and shall not use the
knowledge I know for selfish ends; I shall treat any information I acquired about individuals in the
course of my work as strictly confidential, and may be divulged only to authorized persons or entities
or with consent of the individual when necessary;
I shall report any infractions of these principles of professional conduct to the authorities responsible
of enforcement of applicable laws or regulations, or to the Ethics Committee of the Philippine
Association of Medical Technologists as may be appropriate.
To these principles, I hereby subscribe and pledge to conduct myself at all times in a manner befitting
the dignity of my profession.
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