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MEDTECH LAWS & BIOETHICS

LECTURE 1: RA 10173 DATA PRIVACY ACT OF 2012


CHRISTIAN JOHN E.VILLAHERMOSA, RMT
April 15, 2021
For updates and corrections → @mar4rii on Twitter

- In the laboratory, we allow or require patients to fill out a


OUTLINE form which we intend to collect their personal
information which we need, for us to release the result.
I. Declaration of policy VI. Rights of the data - We have to make sure that the patient is aware why are
we getting this information from them.
II. National Privacy Commission subject
- Lab testing is part of the protected means of gathering
i. Privacy commissioner VII. Prohibited acts and acquiring information.
ii. Deputy privacy VIII. Other information LEGITIMATE PURPOSE
commissioner IX. Pamet code of ethics - compatible with a declared and specified purpose.
III. Data privacy principles - As to personal information, all our intentions and
IV. What is personal information? purposes must be legitimate.
V. Sensitive personal information - In the laboratory, if we ask them for personal information
that is somehow tantamount to a legitimate purpose in
(SPI)
the provision of testing as well as the release of result.
PROPORTIONALITY
- adequate, relevant, suitable, necessary, and not
excessive in relation to a declared and specified
purpose
RA 10173 DATA PRIVACY ACT OF 2012 - dapat equal lang; we need your personal information for
I. DECLARATION OF POLICY this reason.
- to protect the fundamental human right of privacy, of - Any other extraneous reasons for acquiring personal
communication while ensuring free flow of information to information are FORBIDDEN.
promote innovation and growth. IV. WHAT IS PERSONAL INFORMATION?
- to ensure that personal information in information and - any information whether recorded in a material form or
communications systems in the government and in the not, from which the identity of an individual is
private sector are secured and protected. apparent or can be reasonably and directly
▪ In the laboratory, we have to make sure all ascertained by the entity holding the information, or
forms of information shared to us by our when put together with other information would directly
patients are kept private, confidential, secured and certainly identify an individual.
and protected and must ONLY be used in the - In the lab, personal information that is used are: Name,
manner which the patient gave his/her consent. Age, Sex, Address, Birthday (some labs require), Phone
II. NATIONAL PRIVACY COMMISSION number and, etc.
- administers and implements the provisions of this Act - These are shared freely for contact tracing. However, it
- monitors and ensures compliance of the country with should not be a reason for them to be disclosed
international standards set for data protection. inappropriately.
- attached to the Department of Information and - Must be kept at all times and securely and must only be
Communications Technology (DICT) used to their intended purpose (contact tracing, testing
▪ basically because of more pressing concerns and, etc.)
on privacy are done through the information V. SENSITIVE PERSONAL INFORMATION (SPI)
highway or online manner. - an individual’s race, ethnic origin, marital status, age,
- headed by a Privacy Commissioner (also acts as the color, and religious, philosophical or political
Chairman) affiliations
- Assisted by 2 Deputy Privacy Commissioners (1 for - an individual’s health, education, genetic or sexual
Data Processing Systems, 1 for Policies and Planning) life, or to any proceeding for any offense committed or
i. PRIVACY COMMISSIONER alleged to have been committed by such person, the
- at least thirty-five (35) years of age; disposal of such proceedings, or the sentence of any
- good moral character, unquestionable integrity and court in such proceedings
known probity - social security numbers, previous or current health
- recognized expert in the field of information technology records, licenses or its denials, suspension or
and data privacy revocation, and tax returns
- Term: 3 years, may be reappointed for another 3 years - Sexual preference and orientation, genetic
- Same rank with a Department Secretary information
ii. DEPUTY PRIVACY COMMISSIONER - More private and more personal information.
- must be recognized experts in the field of information - These are still considered as personal information
and communications technology and data privacy because they are possessed by a person but they are
- Term: 3 years, may be reappointed for another 3 years sensitive because any form of disclosure of this
- Same rank with a Department Undersecretary information may have a damaging effect to the
III. DATA PRIVACY PRINCIPLES individual.
TRANSPARENCY - Should NOT be disclosed freely, consent is required.
- data subject must be aware of the nature, purpose, and - NOT shared often as they will be prone to any form of
extent of the processing of his or her personal data. maltreatment.
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- Mas protected than personal information. 'Uphold the law and shall not participate in
VI. RIGHTS OF THE DATA SUBJECT Illegal work'
- Be informed - illegal activities in the laboratories include releasing
- Reasonable access (to the means of data gathering) fraudulent results.
- Dispute the inaccuracy or error in the personal - If you did something wrong during testing, admit and try
information to correct the wrong that has been done.
- Suspend, withdraw or order the blocking, removal or ‘Act in a spirit of fairness to all and in a spirit
destruction of his or her personal information from the Of brotherhood toward other members of the
personal information controller’s filing system Profession’
- Be indemnified for any damages sustained - nurses, pharmacists, radiologic technologists,
▪ If the data that the patient or person has physicians, other medical technologists, etc.
shared was used in any other means, other 'Accept employment from more than one employer only when
than what was specified as the legitimate there is no conflict of interest’
purpose. - conflict of interest: a situation that has the potential to
▪ Pede sha maghabol duon sa nag patakag undermine the impartiality of a person/clash between
gamit and can be paid or indemnify for the self-interest and professional interest.
damage sustained. - You cannot work full time in two laboratories at the
- Transmissibility same time.
- Data portability ‘Perform my task with full confidence, absolute
VII. PROHIBITED ACTS Reliability, and accuracy’
- Unauthorized Processing of Personal Information and - proper procedure
Sensitive Personal Information - double checks
- Accessing Personal Information and Sensitive Personal - Case: Garcia v. Salvador (G.R. 168512)PAMET CODE
Information Due to Negligence OF ETHICS
o If u left a folder containing lots of information of 'Share my knowledge and expertise with
different people, it is a negligent act and you My colleagues’
are now liable for damages. - mutual sharing of information (innate or acquired
- Improper Disposal of Personal Information and through trainings and seminars).
Sensitive Personal Information. - In the workplace, you are all equal.
o It is recommended that if you will dispose ‘Contribute to the advancement of professional organization and
papers, it should be shred prior. other allied health organizations’
- Processing of Personal Information and Sensitive - PAMET
Personal Information for Unauthorized Purposes 'Restrict my praises, criticisms, view and opinions within
- Unauthorized Access or Intentional Breach constructive limits'
- Concealment of Security Breaches Involving Sensitive - use the Feedback Sandwich Method (Positive-
Personal Information ImprovePositive)
- Malicious Disclosure - specify and focus on the situation, not the person
o You disclosed the information with the intention - give your recommendations
of embarrassing or humiliating a certain - when assessing person na namali, make sure na dili
individual. sha I criticize harshly. You focus on the situation and not
- Unauthorized Disclosure on the person and give your recommendation after.
VIII. OTHER INFORMATION 'Treat any information i acquired in the course of my work as
•Approved on August 15, 2012 by BenignoAquino III strictly confidential'
- breach of confidentiality: when a patient's private
THE MEDICAL TECHNOLOGIST CODE OF ETHICS information is made available to a third party without
CODE OF ETHICS his/her consent
- ethical benchmarks for professionals - examples: drug testing, HIV testing
- a set of good and bad behavior PAMET CODE OF ETHICS
- a form of legislation that binds a specific profession. 'Uphold the dignity and respect of my profession and conduct
o If you are found guilty of doing something that myself a reputation of reliability, honesty and integrity'
is forbidden, either directly or indirectly by the - reliability: consistency of actions
code of ethics, you will be subjected to - honesty: the quality of being fair and truthful
sanctions. - integrity: moral uprightness
- violations: sanctions Be dedicated to the use of clinical laboratory science to promote
- checklist of what should be done and should not be life and benefit mankind'
done. - help in the diagnosis of diseases
IX. PAMET CODE OF ETHICS - help quell epidemics and outbreaks
- As I enter into the practice of medical technology, I ' Report any violations of the above principles of the professional
shall: conduct to authorized agency and to the ethics committee of the
Accept the responsibilities inherent to being a professional' organization'
- Professionalism - Section 24 of RA 5527
o implies quality of workmanship or service. - 2 Board members plus a legal officer.
o working to defined standards and principles ▪ If u did something wrong then you may be
o tips: investigated.
'To these principles, i hereby subscribe and
▪ be on time Pledge to conduct myself at all times in a
▪ don't be grumpy Manner befitting the dignity of my profession.
▪ dress appropriately
▪ watch your mouth
▪ don't lie

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MEDTECH LAWS & BIOETHICS

LECTURE 4: RA 7170 Organ Donation Act of 1991


CHRISTIAN VILLAHERMOSA, RMT
March 24, 2021
For updates and corrections → @mar4rii on Twitter

- Ang mga kamag-anak ng patay decided to donate the


OUTLINE body parts or the organs of the dead person to another
person.
I. Important details VIII. Amendment or - Donee (recipient of donation)
II. Definition of terms revocation of - The decision to donate is on the family members of the
III. How death is determined? legacy/donation dead person—in this case, the dead person did not
IV. Execution of legacy IX. Rights and duties post- intend to mention that he wanted to donate his body
V. All organ donations mortem parts after his death.
VI. Legatees/donees X. Hope - Ang patay is NOT the donor but is just the decedent,
VII. Delivery of the document of XI. Current issues whereas the donor is ang tao na nagdecide to give the
legacy/donation organs to another person.
PART
- includes transplantable organs, tissues, eyes, bones,
arteries, blood, other fluids, and other portions of the
human body.
RA 7170: ORGAN DONATION ACT OF 1991
III. HOW DEATH IS DETERMINED? (in hospitals)
I. IMPORTANT DETAILS
May patay dapat na mauna bago kumuha ng organs.
- Date of Approval: January 7, 1992
Two ways to fully determined a person is already dead.
- Approved by: Corazon C. Aquino
- In the opinion of the attending physician:
- Total Number of Sections: 19
▪ Absence of natural respiratory and cardiac
- Purpose: 'to authorize the legacy or donation of all or functions
part of ▪ Resuscitation attempts would not be
- a human body after death for specified purposes' successful.
- the major limitation of this act is only on donations or on - In the opinion of the consulting physician:
giving of organs after the death of the person. ▪ Irreversible cessation of all brain functions
- The policy regarding the giving of organs while the ▪ Resuscitation attempts would not be
person is still alive is NOT present in this act. successful.
- Organ donation is not very common in the Philippines - Three (3) functions and determine: respiratory, cardiac,
unlike blood donation—due to religious beliefs or and brain function. – if all three are not present and any
preservation. attempt to revive these functions would not be
- Kidneys are commonly donated. successful then death will be declared.
II. DEFINITION OF TERMS IV. EXECUTION OF LEGACY
ORGAN BANK STORAGE FACILITY - Who may execute a legacy?
- licensed, accredited, and approved to store human ▪ Any individual:
bodies and/or human body parts. o at least 18 years old
- Human body—some people tend to give their whole o of sound mind
body to science or medicine for research and anatomy - How to execute a legacy?
classes. ▪ Last will and testament
- NKTI—major organ bank storage facility. ▪ Organ donor card
DECEDENT - Legacy may be made through:
- a deceased individual (includes a stillborn infant or ▪ a specified legatee (recipient of the legacy) or
fetus) without specifying a legatee.
- any dead person. - The testator may designate surgeons/physicians to
TESTATOR perform the procedure—you have the freedom to select
- an individual who makes a legacy of all or part of his kung sinong surgeon ang magkuha ng organs.
body. - The legacy document should be signed by the testator
- A living person who decided to donate his organs to in the presence of two witnesses.
another person once he dies. ▪ Witnesses are important because they can
- May incorporate his/her wishes or either he can avail an testify you created your legacy without
organ donor card which will entitle the hospital to coercion.
harvest his organs once he dies—he is making a - What if the specified legatee is not around during the
legacy. death of the testator?
- Harvesting of organs will only happen after the death of ▪ The attending physician/surgeon will serve as
the testator. the temporary legatee
- LEGACY- his expression of his desire to donate his - What if the testator did not specify a legatee?
body parts by incorporating in the last will and testament ▪ the attending physician/surgeon will serve as
or avail an organ donor card. the legatee—they have the power to select
- legatee (recipient of legacy). who will be the recipient of the organ.
DONOR - A legacy becomes effective after the death of the
- an individual authorized to donate all or part of the body testator.
of the decedent. - Who may execute a donation?

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▪ Legal spouse - retrieval, preservation, and allocation of organs and
▪ Son or daughter of legal age tissues for clinical transplantation
▪ Either parent - waiting list
▪ Brother or sister of legal age XI. CURRENT ISSUES
▪ Guardian of the decedent at the time of his R. A 9208
death - Anti-trafficking in person act
- What if the nearest kin is absent? Who will execute the o -people in poor communities tend to sell their
donation? organs to mostly other countries who are in
▪ the attending physician need.
▪ the head of the hospital Case: G.R. 175540
▪ designated officer of the hospital - Dr. Filoteo Alano v. Zenaida Magud-Logmao
▪ BUT FIRST... the family of the deceased - Issue: to set aside the CA ruling adjudging the petitioner
should be located within 48 hours. liable for damages
V. IN ALL ORGAN DONATIONS: Facts:
▪ Diagnosis of death should be made separately - March 1, 1988: Arnelito Logmao, then eighteen (18)
by two qualified physicians years old, was brought to the East Avenue Medical
- these physicians should NOT BE: Center (EAMC) in Quezon City by two sidewalk
▪ A member of the medical team who will vendors, who allegedly saw the former fall from the
remove the organ overpass near the Farmers’ Market in Cubao, Quezon
▪ The attending physician of the recipient of the City
organ - Patient’s data sheet identified the patient as Angelito
▪ The head of the hospital/designated officer Lugmoso of Boni Avenue, Mandaluyong
authorizing the removal of the organ - March 2: Logmao was transferred to NKTIAlano v.
o these three people have conflict of interest Magud-Logmao
with regards to organs. They may just - At NKTI, the name Angelito [Logmao] was recorded as
declare its death. Angelito Lugmoso.
- Examination of human body or body parts - Dr. Enrique T. Ona, Chairman of the Department of
▪ Necessary to ensure medical acceptability Surgery, observed that the severity of the brain injury of
▪ Only trained/qualified personnel shall Lugmoso manifested symptoms of brain death
remove/transplant organs o should Lugmoso expire despite the
▪ In case of medico-legal cases: necessary medical care and management
o Perform autopsy to determine suitable and he would be found to be a suitable
organs organ donor and his family would consent to
VI. LEGATEES/DONEES organ donation, the organs thus donated
- Any hospital, physician, or surgeon could be detached and transplanted
- Any accredited medical or dental school, college, or promptly to any compatible beneficiary
university - Certifications were issued by Channel 4, ABS-CBN and
- Any organ bank storage facility GMA attesting that the request made by the NKTI on
- Any specified individual March 2, 1988 to air its appeal to locate the family and
VII. DELIVERY OF THE DOCUMENT OF LEGACY/DONATION relatives of Angelito Lugmoso of Boni Avenue,
If the legacy/donation is made to a specified legatee: Mandaluyong was accommodated
- the legacy/donation documents (will/card/donation - March 3: Angelito was pronounced dead and then a
document) should be delivered to the legatee/donee team of doctors removed the heart, kidneys, pancreas,
- the documents could also be stored in an organ bank liver and spleen of Lugmoso; kidneys and pancreas
storage facility for safekeeping were transplanted immediately to 2 patients
VIII. AMENDMENT OR REVOCATION OF - March 11: NKTI issued a press release announcing its
LEGACY/DONATION successful double organ transplantation
If the will/card/document was delivered: o a cousin of plaintiff, heard the news aired on
- Signed statement television that the donor was an eighteen
o Stating your change of mind or heart. (18) year old boy whose remains were at La
- Oral statement with 2 witnesses (sent to legatee) Funeraria Oro in Quezon City; the cousin
- Dying declaration (physician to legatee) informed Zenaida who went to the funeral
- Signed card/document found on the person home and saw Angelito’s cadaver
o Ex: Tattoo or document - April 29: Zenaida filed a complaint for damages and
if the will/card/document was not delivered: alleged that defendants conspired to remove the
- (Conditions mentioned above) organs of Arnelito while the latter was still alive and that
- Destruction, cancellation, or mutilation of the documents they concealed his true identity.
- Revocation of wills SC VERDICT
IX. RIGHTS AND DUTIES POST-MORTEM - Petitioner instructed his subordinates to "make certain"
- legatee may accept/reject the legacy that "all reasonable efforts" are exerted to locate the
- removal of organs without MUTILATION patient's next of kin, even enumerating ways in which to
o kung ano lang gi wish or gi intend na ibigay ensure that notices of the death of the patient would
yung lang din ang kunin. reach said relatives.
- international sharing of organs or tissues: - The doctors and personnel of NKTI disseminated
RECIPROCITY notices of the death of respondent's son to the media
o if country A asked for an organ from country and sought the assistance of the appropriate police
B, that is okay as long as country A will also authorities as early as March 2, 1988
give organs to Country B - It should be emphasized that the internal organs of the
X. HOPE deceased were removed only after he had been
Human Organ Preservation Effort (HOPE) declared brain dead; thus, the emotional pain suffered
- established in 1983 by respondent due to the death of her son cannot in
- NKTI program that coordinates organ donation any way be attributed to petitioner. Neither can the
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Court find evidence on record to show that
respondent's emotional suffering at the sight of the
pitiful state in which she found her son's lifeless body
be categorically attributed to petitioner's conduct.

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MEDTECH LAWS & BIOETHICS

LECTURE 4: Philippine Clean Water Act of 2004 (RA 9275)


CHRISTIAN VILLAHERMOSA, RMT
March 19, 2021
For updates and corrections → @mar4rii on Twitter

▪ Analyst
OUTLINE o Appropriate bachelor's degree
I. Rules and regulations for drinking IV. Technical o 2 years experience in water testing
water analysis requirements o Chemist/chemical technician (water
II. Drinking water V. Analytical methods chemistry)
III. Water testing laboratories o Medicaltechnologist/microbiologist/othe
r allied health professionals (water
bacteriology)
▪ Laboratory Aide
I. RULES AND REGULATIONS FOR DRINKING WATER ANALYSIS
o 6 months experience on clerical support
RA 9275
and sampling
- Philippine Clean Water Act of 2004
o 2 years of college
- Approved: March 22, 2004 by GMA
- Equipment, Instruments, Reagents, and Supplies
- 'protection, preservation, and revival of the quality of our
▪ Incubator
fresh, brackish, and marine waters'
▪ Drying oven
- Since our water come from natural resources, they have to
▪ Autoclave
undergone treatment and testing first prior to the
▪ Optical counting equipment
distribution to our home to make sure that they are safe.
▪ and others
II. DRINKING WATER
V. ANALYTICAL METHODS
- Clear
- Testing for coliform bacteria
- Colorless
▪ present in the digestive tracts of animals and also
- Free from objectionable taste
found in wastes, and plant/soil material
- And odor
▪ water pollution by coliform has disease potential
- Must not contain: any substances/organisms, chemicals,
- Total coliform: includes bacteria in soil, surface water, and
radioactive materials
human/animal waste
- Contamination comes from: sewage, human or animal
▪ Wherein we determine ALL types coli forms.
excrement, other wastes.
- Fecal coliform (specific counting for fecal coli form): present
III. WATER TESTING LABORATORIES
in gut and feces, more accurate Indication.
- Classification based on service capability
- Escherichia coli: best indicator, major species
▪ Bacteriological Analysis
Presumptive phase:
▪ Biological Analysis
- Lauryl Tryptose Broth (gas formation within 24-48 hours and
▪ Physical Analysis
observe for turbidity)—Turbid: Positive result. If mag positive
▪ Chemical Analysis
proceed to next step (confirmed phase). If NOT, STOP.
▪ Radiological Analysis (only performed by Philippine
Nuclear Research Institute)
▪ Our concern as a medical technologist, we perform
bacteriological analysis of water.
- Certificate of Accreditation: valid for 3 years (BHFS: first
issuance, CHD: renewal)
IV. TECHNICAL REQUIREMENTS
- Physical Plant
▪ Permanent building
▪ Water/power supply
▪ Drainage
▪ System/ventilation
Confirmed phase:
▪ 20 sq.m. Workplace
- Brilliant Green Bile Lactose Broth (gas formation within 24-48
▪ Safety and disposal
hours)—Turbid: POSITIVE. If positve, proceed to completed
▪ Separation between neighboring activities
phase.
o The activities of water testing lab must
be separated with the other activities IF
the lab is located in a complex of
facilities, especially if it’s renting an area.
- Personnel
▪ Head of the laboratory
o With management training
o With a prc license
o At least 3 years of experience in water
testing

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Completed phase:
▪ Single strength Lauryl Tryptose Broth: gas
formation
▪ LES Endo/MacConkey: Gram staining
▪ Best indicator culturing a water sample into a
culture media. One of the media that would be
used is Endo/MacConkey agar which can detect the
presence of E. coli.
▪ Pink colonies indicates a POSITIVE result and
indicates the presence of lactose fermenting coli
form bacteria hence, there is a contamination in
the water supply.

QUALITY/TECHNICAL MANUAL
- types of analysis
- handling/acceptance of specimens
o Sterilized glass bottles (clear, 120 mL)
o Fill the bottle with 100 ml of water
o If from lakes, rivers, dug wells: submerge bottle to
a depth of one foot below the surface.
SPECIMEN COLLECTION
- Clean the tap, flush for 1-2 minutes
- Sterilize the tap
▪ flaming with ignited cotton swab
▪ swab soaked with chlorox or 100 mg/L sodium
hypochlorite solution
- Flush the tap for 1-2 minutes
- Open sampling bottle and fill with water
- Cap the bottle and label (date/time of collection, water
sampling code, name of collector)
- Store and transport the bottle within 6 hours: cooler with ice
within 24 hours
LAB REPORTS
- results, name of head of the lab and analyst, testing facility
LAB RECORDS (retain for a minimum of 5 years)
- personnel records and analytical records
QUALITY MANAGEMENT
- internal quality audit every 6 months
PROFICIENCY TESTING
- NRL: EAM

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MEDTECH LAWS & BIOETHICS

LECTURE 4: Intro to Bioethics


CHRISTIAN JOHN E.VILLAHERMOSA, RMT
May 5, 2021
For updates and corrections → @mar4rii on Twitter

OUTLINE MEDICAL ETHICS


I. . OVERVIEW OF ETHICS VII. PROBLEMS IN MEDICAL - Ethics in medicine/medical practice
AND BIOETHICS ETHICS ETHICS ▪ concerned with the obligations of the doctors and
II. BIOETHICS VIII. IGNORANCE the hospital to the patient along with other health
III. ETHICAL SYSTEMS IX. NEGLIGENCE professionals and society.
IV. THE HEALTHCARE FOUR MAJOR ETHICAL PRINCIPLES
PROFESSION - Autonomy
V. MEDICAL ETHICS - Beneficence
VI. FOUR MAJOR ETHICAL - Non-maleficence
PRINCIPLES - Justice
AUTONOMY
I. OVERVIEW OF ETHICS AND BIOETHICS - The act of respecting the decisions of others
ETHICS - The basis of informed consent: patient must Understand the
- the systematic philosophical study of morality procedure and its likelihood of success
▪ An inquiry into what is right and what is wrong - Free from coercion
▪ Looks into different moral or normative codes in - The patient has the final say on what should be done to his or
society her body.
▪ Concerned with studying and/or building up a - We should not force medical procedures; we should NOT
coherent set of ‘rules’ or principles by which people force treatment of patients without their consent.
ought to live BENEFICENCE
▪ Guide for individuals on what we should do and not - doing an action that benefits others
do. ▪ Intention of doing good for the patient
▪ Subjective- there is certain actions or certain codes ▪ chief objective of health professionals: to
that are allowed in one society and is not allowed help
upon another society. - in contrast with autonomy however, autonomy ang mag
II. BIOETHICS supersede kay autonomy ang mas nangingibabaw.
- ethics focused on moral issues in the field of health care - We can only suggest but we cannot actually force the
III. ETHICAL SYSTEMS procedure to patients.
Deontological ethics NON-MALEFICENCE
- focused on adherence to independent moral rules or duties - The ‘do no harm’ principle
- when you follow your duty, you are behaving morally; when ▪ avoidance of doing harm to others through
you fail to follow your duty, you are behaving immorally. commission or omission
- If a certain action is declared as wrong then it is wrong in all - iniiwasan mo lang na makagawa ng masama to our patients.
forms. JUSTICE
- ‘Give to each that which is his due’
- Treat all patients equally.
Teleological ethics PROBLEMS IN MEDICAL ETHICS
- focused on the consequences which any action might have; - IGNORANCE
ends justifying the means. - NEGLIGENCE
- A certain action becomes right if it benefited other people. ▪ Medical Negligence/Medical MalpracticeI
- The end justifies the means (ex: Case of Robin Hood). IGNORANCE
Virtue ethics - lack of technical or theoretical knowledge in the act of doing
- focus on helping people develop good character traits, such work
as kindness and generosity, which allow a person to make the - examples: incompetent, no experience, no knowledge of
correct decisions later in life. consequence, failure of job execution
- Middle ground between teleological and Deontological ethics. - may nagawa kang mali kasi hindi mo alam kung ano ang
- They do not ascribe a certain action as right or wrong but it mali.
gives freedom to other interpretation. - More forgivable.
THE HEALTHCARE PROFESSION NEGLIGENCE
“Professional practice is defined as practice that reflects the - the failure to observe, for the protection of the interests of
commitment to caring relationships with patients and families and another person, that degree of care, precaution, and
strong ethical values; utilization of specialized knowledge, critical vigilance which the circumstances justly demand, whereby
inquiry, and evidence-informed decision making; continuous such other person suffers injury
development of self and others; accountability and responsibility for - failed to take an action that a reasonable person would do
insightful competent practice; demonstration of a spirit of - did something that a reasonable person would not do
collaboration and flexibility to optimize service.” - alam mo ang ginagawa mo pero may nagawa kang mali.
▪ MEDICAL MALPRACTICE
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▪ ’a particular form of negligence which - direct result of the doctor’s breach
consists in the failure of a physician or - testimony of an expert witness
surgeon to apply to his practice of - Doctrine of res ipsa loquitur (‘the thing speaks for itself’): if
medicine that degree of care and skill availed, the need for expert witnesses is dispensed with
which is ordinarily employed by the ▪ Obvious na may injury.
profession generally, under similar - It REQUIRES a testimony form expert witness.
conditions, and in like surrounding EXPERT WITNESS TESTIMONY
circumstances’ (Reyes vs. Sisters of Mercy - special knowledge experience and practical training that
Hospital) qualify him/her to explain highly technical medical matters to
the Court.
ELEMENTS OF NEGLIGENCE ▪ It is very important na magtungma ang
- a duty was owed expert witness sa kaso.
▪ mag create muna ang isang - Ramos v. CA: the expert witness, who is a pulmonologist, not
physician-patient relationship if wala, the qualified to testify on the field of anesthesiology
other elements would not hold water. - Cereno v. CA: The Court excluded the testimony of an expert
- the duty was not met: breach witness whose specialty was anesthesiology, and concluded
- injury or harm was done that an anesthesiologist cannot be considered an expert in
- failure to meet the duty owed resulted to the injury: the field of surgery or even in surgical practices and
proximate cause diagnosis.
DUTY - The court tends to favor witnesses with long work experience
- There must be a professional relationship between the (ex. OB for 30 years).
patient and the physician RES IPSA LOQUITUR
▪ created when the patient engages the - allows the mere existence of an injury to justify a
services of the doctor and the doctor presumption of negligence on the part of the person who
agrees to provide care to the patient controls the instrument causing the injury
- may be implied from the physician's affirmative action to - no need for an expert witness. Pagtingin mo palang sa case
diagnose and/or treat a patient, or in his participation in such alam mo na may nangyari ng mali.
diagnosis and/or treatment Elements
- even if injury, breach and proximate cause created, if there is 1. The accident is of a kind which ordinarily does not
no duty, wala ding kaso. occur in the absence of someone’s negligence;
JARCIA V. PEOPLE 2. It is caused by an instrumentality within the
- A patient was hit by a taxi and was sent to a hospital exclusive control of the defendant or defendants;
- 2 doctors ordered an x-ray which showed no fracture 3. The possibility of contributing conduct would make
▪ Told the mother that there is no need to the plaintiff responsible is eliminated.
examine the whole leg because only the CANTRE V. GO
ankle was hit - Injury in left arm of a woman after giving birth
Patient developed fever, swelling of the - Wound was caused by constant taking of blood pressure:
right leg, and misalignment of the right forgot to deflate the BP cuff after use
foot: had mid-tibial fracture - Wound is not an ordinary occurrence after childbirth
- Doctors’ arguments: they were just passing by the ER for - Sphygmomanometer is under the supervision of the
lunch physician
- These doctors ordered and x-ray, gave medication and - Wound was outside the control of the mother
recommended care to the patient is already and implied BATIQUIN V. CA
physician-patient relationship. - A piece of a rubber glove was left on the patient’s uterus
- Hindi kailangan na siya talag ang attending physician. after giving birth
BREACH - Patient became feverish, pale, and breathing fast plus with
- breach of the standard of care/improper performance an infection in the abdominal cavity
expected of other similarly trained medical professionals - After another surgery, the ovaries were infected and had to
acting under the same circumstances be removed
- may mali kang ginawa na other doctors would not do given PROXIMATE CAUSE
the same set of circumstances. - ‘the cause which produces the injury and without which the
BORROMEO V. FAMILY CARE HOSPITAL result would not have occurred’
- Borromeo’s wife was sent to the hospital for acute - The breach committed by the physician is the direct cause of
appendicitis your injury.
- Post-op, patient had low blood pressure and was - Bataclan v. Medina
unresponsive to blood transfusion and IV infusion ▪ Bus overturned on a ditch and 4
- Patient became restless and pale and then died (hemorrhage passengers were trapped
due to disseminated intravascular coagulation is the COD) ▪ Rescuers, carrying a light torch, arrived
▪ DIC- a certain disorder wherein naubos and immediately, a fierce fire started
ang clotting factors sa katawan. burning the bus and the passengers
▪ Initiated by infection or sepsis. burned to death
- Issue: Is there negligence? ▪ Issue: Whether the proximate cause of
- SC verdict: NO MEDICAL MALPRACTICE (the death was due to the deaths was the overturning of the
a medical disorder) bus or the fire that burned the bus
▪ no proof that the doctor fell short of the ▪ The proximate cause is the overturning.
expected standard required under the Dili man mangadto ang mga rescuers
circumstances carrying a light torch kung wala nag
INJURY overturn ang bus in the first place.
2
CASUMPANG V. CORTEJO Capacity
- Mrs. Cortejo brought her son to the hospital because of - refers to the patient’s ability to understand the information
difficulty in breathing, chest pain, stomach pain, and fever and to appreciate those consequences of his or her decision
- Doctors diagnosed the child with bronchopneumonia: the that might reasonably be foreseen.
mother had doubts Voluntariness
- After episodes of vomiting blood, the boy was diagnosed - refers to the patient’s right to come to a decision freely,
with dengue hemorrhagic Fever without force, coercion, or manipulation.
- The boy was transferred to the ICU of another hospital where WHAT SHOULD BE EXPLAINED TO PATIENTS?
he was diagnosed with DHF stage IV and died soon after - Nature of the procedure
- Dr. Casumpang was liable of negligence in diagnosis - Risk/s of the procedure
▪ selectively appreciated some, and not all of the - Alternative/s to the procedure
symptoms; worse, he casually ignored the pieces of - Expected benefits of the procedure
information that could have been material in - Potential consequences of not doing anything
detecting dengue fever. LI V. SPOUSES SOLIMAN
- The SC clarified that a wrong diagnosis is not by itself - Issue: Whether Dr. Li can be held liable for failure to fully
medical malpractice disclose serious side effects to the parents of the patient?
▪ But: when the physician's erroneous diagnosis was - SC ruled in favor of Dr. Li
the result of negligent conduct (e.g., neglect of ▪ There was adequate disclosure of material risks
medical history, failure to order the appropriate inherent in the chemotherapy procedure
tests, failure to recognize symptoms), it becomes performed with the consent of Angelica's parents
an evidence of medical malpractice. ▪ Px’s immune system was already weak on the
- Proximate cause: the SC considered expert testimony stating account of the tumor
that with correct and timely diagnosis and proper medical ▪ Each patient's reaction to the chemical agents even
management, dengue fever is not a life-threatening disease with pre-treatment laboratory tests cannot be
and could easily be cured precisely determined by the physician
- Dr. Casumpang's failure to timely diagnose the boy with IN CASE THE PATIENT IS INCAPABLE OF GIVING CONSENT…
dengue, the latter was not immediately given the proper - Spouse
treatment. - Son or daughter of legal age
CAPTAIN OF THE SHIP DOCTRINE - Either parent
- the operating surgeon is the person in complete charge of - Brother or sister of legal age
the surgery room and all personnel connected with the - Guardian
operation.
PROFESSIONAL SERVICES INC. V. AGANA
- patient was rushed to the hospital wherein a doctor INTENTIONAL NONDISCLOSURE
diagnosed her to be suffering from cancer of the sigmoid and Intentionally not disclosing information to a patient or surrogate
the cancer has spread to the ovary is legal in situations of emergency or when patients waive their right to
- Surgeon performed anterior resection and hysterectomy be informed
▪ decided to close the incision despite the fact that - if physicians believe “divulging the information would
the attending nurses informed him that there were potentially harm a depressed, emotionally drained, or
missing gauzes unstable patient”
- Patient complained of pain in the anal region and 2 pieces of - use of placebos when used properly during experimental
gauze were extracted from her vagina research
- The surgeon was held liable - if the research is relatively risk-free to the participants and
CONSENT when the nature of the research is behavioral or
- An act of voluntary agreement between two parties psychological and disclosure might seriously skew the
- IMPLIED CONSENT outcomes of the research
- INFORMED CONSENT HOME AGAINST MEDICAL ADVICE (HAMA)
THE DOCTRINE OF INFORMED CONSENT - Autonomy vs. beneficence
- ‘Every human being of adult years and sound mind has a - A prudent and reasonable physician will not leave the
right to determine what shall be done with his own body; patient at the mercy of a layman’s decision (provide
and a surgeon who performs an operation without the medication plans and follow-up visits)
patient's consent commits an assault, for which he is liable - ‘…if a patient leaves the hospital contrary to instructions, the
in damages. This is true, except in cases of medical physician is not liable for subsequent events’ (Runez vs.
emergency, where the patient is unconscious, and where it Jurado)
is necessary to operate before consent can be obtained.’ - ‘There is no expectation from doctors that they track down
(Schloendorff vs. Society of New York Hospitals) each patient who apparently missed their appointments or
- “the patient's right of self-decision can only be effectively force them to comply with their directives. After all, a person
exercised if the patient possesses adequate information to is still the master of his own body.’
enable him in making an intelligent choice” (Li v. Spouses - Where a patient wants to be discharged even if the doctor
Soliman) believes na dili pa ready ang patient to be discharged.
- “the scope of disclosure is premised on the fact that patients - Pede pa ulion ang patients but medication and treatment
ordinarily are persons unlearned in the medical sciences” must be provided.
(Li v. Spouses Soliman) PATIENT DETENTION
- Must be phrased in layman’s terms. - only allowed in cases if ang patient is prisoner.
COMPONENTS OF INFORMED CONSENT - Detained or convicted prisoner; with a very contagious
Disclosure disease; mentally-ill
- refers to the communication of relevant information by the - ‘…if the patient cannot pay the hospital or physicians bill, the
clinician and its comprehension by the patient. law provides a remedy for them to pursue, that is, by filing
3
the necessary suit in court for the recovery of such fee or
bill’
- ‘…if the patient is prevented from leaving the hospital for
his inability to pay the bill, any person who can act on his
behalf can apply in court for the issuance of the writ of
habeas corpus’ (MDH vs. Chua)
RA 9439
- Prohibits patient detention on the grounds of non-payment
of hospital bills
- Requires execution of a promissory note covering the unpaid
obligation
- HOWEVER…patients in private rooms are NOT covered by
this act
PATIENT CONFIDENTIALITY
- The patient has the right to privacy and protection from
unwarranted publicity.
- Disclosure of confidential information
▪ Patient condition is in controversy in a court
litigation
▪ When public health or safety demands
▪ With patient consent
▪ Patient’s condition is discussed in a scientific
forum
RIGHT TO INFORMATION
- Result of the evaluation of the nature and extent of the
disease, administration of treatment and procedures
- Itemized bill of the hospital and medical services
- Continuing health care requirements following discharge
- Medical record
RIGHT TO EXPRESS GRIEVANCES
- Express complaints and grievances without fear of
discrimination
RIGHT TO RELIGIOUS BELIEF
- Right to refuse medical treatment or procedures which may
be contrary to religious beliefs
RIGHT TO QUALITY CARE AND HUMANE TREATMENT
- No discrimination
- Good quality of service
CIVIL CODE PROVISIONS
- Art. 19. “Every person must, in the exercise of his rights and
in the performance of his duties, act with justice, give
everyone his due and observe honesty and good faith.”
- Art. 20. “Every person who, contrary to law, willfully or
negligently causes damage to another, shall indemnify the
latter for the same.”
- Art. 21. “Any person who willfully causes loss or injury to
another in manner that is contrary to morals, good customs
or public policy shall compensate the latter for the damage.

4
MEDTECH LAWS & BIOETHICS

LECTURE 1: Bioethical issues (from past to present)


CHRISTIAN JOHN E.VILLAHERMOSA, RMT
May 17, 2021
For updates and corrections → @mar4rii on Twitter

These two (2) international codes govern all international researches


OUTLINE which may be conducted on human beings. Dapat mapasa mo to
I. HUMAN SUBJECTS OF (Nuremberg and Helsinki) before you will be given the ethical clearance
RESEARCH/HUMAN to start your study.
EXPERIMENTATION ABORTION
II. INTERNATIONAL CODES - a medical or surgical procedure that deliberately ends a
III. ABORTION pregnancy before an embryo or fetus is born
IV. ABORTION IN THE PHILIPPINES - Pro: it is a woman's right to have access to safe, legal
EUTHANASIA abortions. —it should be regulated kay para shang murder
V. BIOPROSPECTING/BIOPIRACY so it should be forbidden.
VI. And many more XD - Against: religious or ethical reasons
- Roe v. Wade: ruled that the Constitution protects a woman's
right to an abortion through the end of the first trimester;
introduced regulations for the second trimester and to ban
HUMAN SUBJECTS OF RESEARCH/HUMAN EXPERIMENTATION abortion after the fetus has reached viability except in cases
Tuskegee syphilis study where the mother's health is endangered.
- 600 African American men from Macon County, Alabama ▪ Okay lang ang abortion up to first three (3) months
were enlisted to partake in a scientific experiment on syphilis of pregnancy. From four (4) months to the 9th
- subjects were unaware of this and were simply told they months hindi na sha allowed.
were receiving treatment for bad blood - Introduced regulations for any abortion during the second
- 'scientific racism' trimester.
- Testing on humans is actually allowed but this procedure is - Okay sa first trimester na ma abort. Sa second trimester
governed by certain rules and regulations. onwards, I regulate na. Either if it endangers the life of the
- You have to be able to present the nature of your study to mother and if the pregnancy is a product of rape or incest.
your human subjects before you can start. ABORTION IN THE PHILIPPINES
- Human subjects must have the capacity to understand what - remains illegal under all circumstances and is highly
you will perform on them and as well as they should be able stigmatized
to sign voluntarily. - 27 abortions per 1,000 women of reproductive age in 2000
- Tuskegee syphilis study: if they give their consent, they will be ▪ Inability to afford the cost of raising a child or an
treated but the subjects were deceived in a way. In the actual additional child
conduct of the study, there was no drug that was given to ▪ Pregnancy would endanger their health
them. ▪ their partner or another family member did not
- Actually, the study was just to observe the national want or support the pregnancy
progression of UNTREATED syphilis. ▪ result of forced sex.
- These men still died but the public health service still gave - In 2008, an estimated 1,000 maternal deaths in the
them money for the burial. Philippines were attributable to abortion complications.
- PROBLEM: concept of informed consent. Proper disclosure - Why do some women have abortion? They do it illegally. It is
must be present before the subject can consent to the study. done secretly and therefore unregulated.
INTERNATIONAL CODES EUTHANASIA
Concern human experimentation. It has already been - the practice of ending the life of a patient to limit the
established that you cannot perform experiments on human beings patient's suffering—the patient is not yet dead pero pinatay
easily. You must be governed by international codes and regulations or hinayaang mamatay to end the suffering.
which supports the civil rights and humans rights of all human beings - Active: killing a patient by, for example, injecting a patient
which will become potentially subjects of your experiments. with a lethal dose of a drug
Nuremberg Code - Passive: intentionally letting a patient die by withholding
- 10 standards to which physicians must conform when artificial life support such as a ventilator or feeding tube.
carrying out experiments on human subjects - Pro: patients should have the right to do what they want
- enunciates the requirement of voluntary informed consent with their own lives; patients who are in vegetative states
- doctors may perform experiment on human subjects but it with no prospect of recovery, letting them die prevents
has to be satisfactorily complied with the requirement of the future needless and futile treatment efforts
Nuremberg code. - Against: killing is always wrong; violates an obligation to do
Declaration of Helsinki no harm—violation of non-maleficence.
- states that potential subjects should only give consent after BIOPROSPECTING/BIOPIRACY
being fully informed of the study's setup, goals, and sources - Bioprospecting
of funding; potential conflicts of interest; researcher ▪ the exploration of biodiversity for new biological
affiliation(s); risks and benefits; and their right to withdraw resources of social and economic value.
- parang improvement sa Nuremberg code. ▪ One country will go to another country to scout for
plants or products which could be utilized for
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medications. Especially if a plant is only growing or - The body will be placed in a large metal tank filled with liquid
endemic only in one country or in one specific nitrogen na naka preserve around -196 degrees Celsius
region of a country. - Naka upside down ang paglagay ng body sa tank kasi if ever
▪ Allowed. may leak the brain will still be immersed in the freezing liquid.
- Biopiracy EUGENICS
▪ making use of local medicinal knowledge without - a movement that is aimed at improving the genetic
acknowledging that it is indigenous intellectual composition of humanity
property. - advocated selective breeding to achieve these goals
▪ Ipinagbabawal kasi you are pirating the knowledge - technologies that make it possible to more directly alter the
of the local tribes and passing them as your own. genetic composition of an individual
▪ 'historically rooted in colonialism' –most countries - American eugenicists focused on efforts to stop the
nan aga perform ng biopiracy are colonizers. transmission of negative or "undesirable" traits from
- Rio Declaration generation to generation.
▪ clarified the rights of indigenous people and local - Goal: to preserve the most desirable quality in man and
communities to control the use of intellectual tatanggalin and undesirable.
property and to establish equitable benefit sharing HELA CELLS
▪ regulates bio prospective. - Cancer cells from Henrietta Lacks which became the first
▪ If you were able to accrue or accumulate riches human "cell line"
because of our information then you have to give ▪ Cell line- parang collection of cells which are used in
back to us and you have to recognize that our role various experiments.
as the first people to have identified the properties ▪ These cells have the capacity to multiply
that you are selling. uncontrollably—faster than cancer cells.
THE NEEM TREE CASE - Her surgeon took a tissue biopsy of her cancerous womb
- U.S. multinational corporation W.R. Grace's 1994 patent for a without her knowledge or consent and was passed to cancer
neem tree seed extract used in their antifungal spray, researchers in the same hospital who were astonished by the
Neemex ability of the cells to replicate in laboratory culture
- neem extracts had been used by rural farmers in India for - some 70,000 studies have been published involving the use
more than 2,000 years in insect repellants, soaps and of HeLa cells
contraceptives. ▪ Including the creation of the first polio vaccine, the
- Walang benefit sharing na nangyari. identification of HIV, and the link between human
- Na revoke and patent ni W.R. Grace. papilloma virus and cervical cancer
CRYONICS
- an effort to save lives by using cold temperatures to preserve THE GREAT APE PROJECT
the dead for decades or centuries until a future medical - an appeal of scientists aiming at the legal equalization of the
technology can restore that person to full health non-human great apes (chimpanzees, gorillas and
- Aim: to keep bodies in a stable, preserved state until the orangutans) with man – they are used first prior to human
necessary medical technology arrives experimentations.
- Not a guarantee: "like an ambulance ride to a future hospital - securing three basic rights for all great apes:
that may or may not exist". ▪ The Right of Life
- Once namatay ang isang tao, ilalagay sha isang stable ▪ The Protection of Individual Liberty
preserve state na very very cold temperature until they will ▪ The Prohibition of Torture
be “resurrected” by a future technology. POLITICAL ABUSE OF PSYCHIATRY
- the misuse of psychiatric diagnosis, treatment and detention
HOW DOES CRYONICS WORK for the purposes of obstructing the fundamental human
- Once na the person died, ma pronounce na legally dead, I rights of certain individuals and groups in society
stabilize yung kaniyang body to supply the brain with enough - abuses of the human rights of those politically opposed to
the state are often hidden under the guise of psychiatric
treatment
- Sending people to a psychiatric institution is particularly
practical
- declaring a person mentally ill provides a perfect opportunity
not to respond to their political or religious convictions
- if certain people published articles that are critical of the
government or spearheading movement which are against
the government. The government response is to make use of
the psychiatrist at the governments disposal to declare those
people as insane or mentally ill therefore they need to be
detained in a psychiatric hospital.
- Abuse of human rights of those politically opposed to the
state.
oxygen and blood to preserve minimal function
- I susubject through cooling; the body is packed in ice and PAP IN THE USSR (Union of Soviet Socialist Republics)
injekan (xD) yung patient ng heparin to prevent his or her - development of the concept of 'sluggish schizophrenia' by Dr
blood from clotting. Andrei Snezhnevsky, the director of the Institute of
- Heparin: I remove yung water sa body ng decedent and I Psychiatry for the Soviet Union
replace ng isang anti-freeze para hindi mag freeze and body. - Also developed 'reformist delusions', which was a form
- I co-cool ang body sa dry ice until it reaches the -130 degree ofparanoid schizophrenia
Celsius
2
- Main hospital: Serbski Institute for Forensic Psychiatry in
Moscow
CASES OF PAP
Pyotr Chaadayev
- was imprisoned by Tsar Nicholas I after publishing an article
criticizing the backwardness of Russian society
- first person to be incarcerated in the psychiatric institution
because he was a critique of the backwardness of the Russian
society under the rule of Tsar Nicholas I.
- before USSR
Vasily Mikaelovich Stetsik
- editor of the journal that contained articles critical of the
authorities, was beaten, jailed, and then sent to a psychiatric
hospital. Childhood immunization schedule
Sergei Ablamsky - given to children.
- a lawyer who accused a local prosecutor of corruption, was - BCG and Hep B—given directly after birth.
taken in handcuffs to a psychiatric institution where he was
detained for 4 weeks.
Marina Kalashnikova
- a journalist who published articles critical of the Russian
Government, was forcibly incarcerated in a psychiatric clinic
for 35 days and was poisoned with mercury.
In all these cases, the diagnosis of a psychiatric disease or disorder was
done in order to stop these people from continuing their campaign for
reform and to stop them criticizing their govt. further.
PAP IN CONTEXT
- Psychiatry is particularly unique among the specialties of the
medical profession in that it has the power to remove liberty
- all mental health professionals and those of the future must
have an awareness of how these abuses can happen and an
unwillingness to become part of a system that is oppressive Dengvaxia was a good vaccine for children who had never infected with
- Political abuse of psychiatry can occur in more democratic dengue. It becomes a problem if meron ka ng prior exposure ng dengue
systems, but such abuse can be ameliorated and weakened tas nag pa vaccine.
by a strong active and aware professional body of mental
health professionals. VACCINE HESITANCY IN THE PHILIPPINES
- Common in countries na authoritarian and can also occur in - London School of Hygiene and Tropical Medicine vaccine
democratic systems. confidence project report
HAWAII DECLARATION ▪ the respondents' views that vaccines are
- Issued by the World Psychiatric Association important decreased from 93% (2015) to 32%
- "The Psychiatrist must never use his professional possibilities (2018); safe and effective from 82% (2015) down
to violate the dignity or human rights of any individual or to 21% (2018) and vaccine confidence dropped
group and should never let inappropriate personal desires or from 93 (2015) to 32% (2018)
feelings prejudices or beliefs interfere with the treatment. • Measles and polio outbreak in 2019
The psychiatrist must on no account utilize the tools of his ADDRESSING VACCINE HESITANCY
profession once the absence of psychiatric illness has been - Start early
established. If a patient or some third-party demand contrary - Present vaccination as the default approach
to scientific knowledge or ethical principle, the psychiatrist - Focus on protection for the child and community
must refuse to cooperate." - Build trust with parents Tell stories in addition to providing
- Regulates the PAP scientific facts
VACCINE HESITANCY - Be honest about side effects when asked, and reassure
- refers to the delay in acceptance or refusal of vaccines parents of a robust vaccine safety system
despite availability of vaccination services
Reasons: Hehe my bad karon lang na upload. GL guys 😉. Godbless sa exam
- lack of confidence (in effectiveness, safety, the system, or tom.
policy makers)
- complacency (perceived low risk of acquiring VPDs)
- lack of convenience (in the availability, accessibility, and
appeal of immunization services, including time, place,
language, and cultural contexts)

- media reports highlight a rare occurrence of an adverse


reaction to a vaccine, or associating certain disorders to
vaccines or their components

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