SEMR Midterm PDF
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This document appears to be a portion of a midterm exam paper regarding data privacy. It covers the Data Privacy Act of 2012 and discusses sections, significance, coverage, and other related aspects.
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REPUBLIC ACT NO. 10173 DATA PRIVACY ACT OF 2012 How important is data privacy to our As clients? As a healthcare provider, most of the data you “An act protecting individu...
REPUBLIC ACT NO. 10173 DATA PRIVACY ACT OF 2012 How important is data privacy to our As clients? As a healthcare provider, most of the data you “An act protecting individual personal information in process are considered sensitive personal information. information and communications systems in the government Data privacy measures ensure your client that and the private sector, creating for this purpose a national this information are safe and secured. privacy commission, and for other purposes.” It guarantees them that their data are protected at all times. SUMMARY OF RA 10173: Data are not exposed to risks and vulnerabilities “To protect the fundamental human right of like unauthorized access, processing, sharing and privacy, of communication while ensuring free disclosure. flow of information to promote innovation and What is the Data Privacy Act of 2012? SIGNIFICANCE growth and its inherent obligation to ensure that Republic Act No. 10173 is also known as the Data Privacy Act personal information in information and of 2012 (DPA). communications systems in the government and Protects the privacy of individuals while ensuring free in the private sector are secured and protected.” flow of information to promote innovation and The DPA and its Implementing Rules and growth Regulations (IRR) apply to all acts done or practices engaged in and outside of Regulates the collection, recording, organization, the Philippines if: storage, updating or modification, retrieval, The person, either an individual or an Consultation, use, consolidation, blocking, erasure or institution, involved in the processing of personal destruction of personal data; and COVERAGE OF data is located in the Philippines; Ensures that the Philippines complies with THE ACT The act or practice involves personal data of a international standards set for data protection Philippine citizen or Philippine resident; through national privacy commission The processing of personal data is done in the Personal Information Philippines; or o Refers to any information whether recorded in a The act, practice or processing of personal data material form or not, from which the identity of an is done by an entity with links to the Philippines, individual is apparent or can be reasonably and subject to international law and comity. directly ascertained by the entity holding the NUMBER OF 45 information, or when put together with other SECTIONS information would directly and certainly identify an IMPLEMENTER National Privacy Commission (NPC) OF DPA individual. PRESIDENT Sensitive Personal Information WHO SIGNED Benigno Aquino III o Individual’s race, ethnic origin, marital status, age, THE color, and religious, philosophical or political APPROVAL affiliations DATE OF August 15, 2012 o Individual’s health, education, genetic or sexual life of APPROVAL a person o Any proceeding for any offense committed or alleged What is data privacy? to have been committed by such person, the disposal The right of an individual to control the collection of, of such proceedings, or the sentence of any court in access to, and use of personal information about him or her such proceedings that are under the control or custody of the government or the o Social security numbers, previous or current health private sector. records, licenses or its denials, suspension or revocation, and tax returns Why is data privacy important in the Health and Hospitals o Data specifically established by an executive order or Sector? an act of congress to be kept classified Healthcare services are largely dependent on the free KEY DPA ACTORS flow of information among all participants – be it the client, the National Privacy Commission NPC healthcare worker or the health institution. - is the country’s privacy watchdog; an independent body mandated to administer and implement the When clients feel confident that their information are DPA, and to monitor and ensure compliance of the safe and secured at the hands of their healthcare provider, it country with international standards set for data encourages them to provide complete and accurate data. protection. Functions: **In the healthcare industry, among such PICs or PIPs are the Rule Making: develop, promulgate, review or amend rules following: hospitals including primary care facilities, multi- and regulations specialty clinics, custodial care facilities, diagnostic or Advisory: the advisory body on matters affecting therapeutic facilities, specialized out-patient facilities, and protection of personal data other organizations processing genetic data. Public Education: to inform and educate the public of data Data Privacy Officer (DPO) privacy, data protection, and fair information rights and Appointing a Data Protection Officer (DPO) is a legal responsibilities. Requirement for personal information controllers Compliance and Monitoring: perform compliance and (pics) and personal information processors (pips). monitoring functions to ensure effective implementation A DPO is assigned if you are a natural or juridical of the act person or any other body in the government or Complaints and Investigations: adjudicate on complaints private sector engaged in the processing of personal and investigations on matters affecting personal data data of individuals living within and outside the Enforcement: perform all acts as may be necessary to Philippines. effectively implement the act, including the imposition of An individual PIC or PIP shall be a de facto DPO and administrative sanctions, fines, or penalties. register only if they process sensitive personal Data subject information of at least 1000 individuals. An individual whose personal data is processed Personal information controller (PIC) Privacy Notice vs. Privacy Consent A natural or juridical person, or any other body who A privacy notice is a statement A privacy consent is an indication controls the processing of personal data made to a data subject that of will, whereby the data subject Controls the collection, holding, processing or use of describes how the organization agrees to the processing of his or personal information, including a person or collects, uses, retains and her information. organization who instructs another person or discloses personal information. organization to collect, hold, process, use, transfer or It is sometimes referred to as a privacy statement, a fair disclose personal information on his or her behalf processing statement, or Personal information processor (PIP) privacy policy. A natural or juridical person, or any other body to whom a PIC may outsource or instruct the processing PENALTIES of personal data Violation Imprisonment Fine What is Personal Information(PI)? PI SPI PI SPI PI refers to any information from which the Unauthorized 1 – 3yrs 3 – 6yrs P500,000- P500,000- identity of an individual is apparent or can be reasonably Processing 2,000,000 4,000,000 and directly ascertained, or when put together with Accessing due 1 – 3yrs 3 – 6yrs P500,000- P500,000- other information would directly and certainly identify to Negligence 2,000,000 4,000,000 an individual Improper 6months 1 – 3yrs P100,000- P100,000- Disposal – 2 years 500,000 1,000,000 Criteria For Lawful Processing of PI Processing for 1yr and 6 P500,000- P500,000- Consent Legal obligation unauthorized months – 2 – 7yrs 1,000,000 2,000,000 Contract with the individual Vital interests/Life & health purposes 5 years National emergency / public Constitutional or statutory Unauthorized 1-3yrs 3 – 5yrs P500,000- P1,000,000- order & safety, as mandate of a public discloser 1,000,000 5,000,000 prescribed by law authority Concealment of 1yr and 6 P500,000- Legitimate interests of the PIC or third parties security months – 1,000,000 breaches 5 years What are a PIC or PIP’s Primary Obligations? Unauthorized Adhere to data privacy principles access or 1 – 3 years P500,000- 2,000,000 Transparency Legitimate purpose Proportionality Intentional Uphold data subject rights breach Information Access Data Portability Malicious 1 year and 6 months P500,000- 1,000,000 Rectification Ensure or blocking To object Disclosure – 5 years To file a complaint To damages Combination or 3 – 6 years P1,000,000- 5,000,000 Implement security measures Series of Acts Organizational Physical Technical AUTOMATION IN HISTOPATHOLOGY Conventional Tissue Processing: 1. Fixation PATHOLOGY – Ancient Greek words: “pathos” (pain/suffering) 2. Decalcification and “logos” (study of biology) 3. Dehydration – Also called Pathobiology 4. Clearing – Study of the structural and functional changes in 5. Impregnation cells, tissues, and organs that underlie disease. 6. Embedding – Pathology is the study of the cellular 7. Trimming abnormalities. 8. Section-cutting – Pathology is a branch of medical science that 9. Staining involves the study and the diagnose of disease 10. Mounting through the examination pf surgically removed 11. Labelling organs, tissues, bodily fluids, and in some cases the whole body. Use of Automation in Histopathology Laboratory "All diseases originate at the cellular level, and diseases and In the clinical laboratory, automation is used to underlying mechanism are best understood in the context of describe the maximum use of specimen processing normal cellular structure and function." - VIRCHOW like tissue processing, equipment and reagent AUTOPSY handling by instruments to perform laboratory tests – Ancient Greek words: “auto” and “opsis” with minimum involvement of specialist. – Also called: Necroscopy/ Post-Mortem *Automation is a self-regulation process and the large Examination number of samples can be tested in a short period of – Systematic examination of a cadaver for study or time. for determining the cause of death. In automation of histopathology, technician It uses many methodical procedures to automated the tissue for determine the etiology and pathogenesis of the automatically prepare tissue samples for laboratory diseases. It can also be for epidemiological testing by: purposes, for establishment of genetic causes o Fixing and for family council. o Dehydration BIOPSY o Clearing and – Examination of cells or tissues from a living o Infiltrating with paraffin organism. – Excised material may be studied in order to Advantages of Automation in Histopathology Laboratory diagnose disease or to confirm findings of Shortens processing time normality. Speeds up productivity * Excised material can be Incisions/Excision Peaks and troughs can be eliminated removal of the entire tumor in question. Steady workflow can be managed Incisions maybe made and it could be a removal of partial lesions while Excision is removal of the Types of Automated Machines in Histopathology entire tumor A. Automated Tissue Processing *Basic principle for tissue processing requires the HISTOTECHNOLOGY exchange of fluids using a series of solution for a – Is the art and science performed by the predetermined length of time in a controlled Histotechnologist to produce a tissue section of good environment. quality that will enable the pathologist to diagnose Recent advances includes: the presence or absence of disease. o Tissue processors o Microwave ovens HISTOPATHOLOGIC TECHNIQUE o Rapid Processors with Multi-Sectioned Retorts – Involves different procedures that have been adopted for the preparation of materials microscopic Tissue Processors Types examination. Tissue Transfer Type Processor (Linear/ Carousel) – They deals/focuses with histology. Self-Contained Fluid Exchange Systems * histology is a branch of biology that studies the microscopic anatomy of the biological tissues (microscopic counterpart of gross anatomy) Tissue Transfer Type Processor (Linear/ Carousel) Retorts are sealed – prevents tissue drying Customized schedules for tissue processing There is a fluid spillage containment and elimination of fumes Employ alarm systems and diagnostic programs for troubleshooting any instrumentation malfunction * allows the user a safe, clean and easy reagent renewable Microwave Ovens or Processors – Tissue blocks are transported in baskets. – Reagents are house in stationary containers – Submerged specimen’s length of time in each container is electronically controlled – Vertical oscillation or rotary movement of the tissue basket provides the agitation Advantages: Allow maximum flexibility in the choice of reagent – Technique was first used by Boon and Kok in 1985. It and schedules. shortens the processing time from hours to minutes Rapid turnaround time for day/night processing. by stimulating diffusion of the solutions into the Disadvantages: tissue by increasing the internal heat of the specimen. Tissues dry while being transferred Thus, accelerating the reaction. *But in the recent models, tissue basket is enclosed – Reagents use: Ethanol, Isopropanol and Propriety within an integral fume hood that allow escape of Mixtures of Alcohol and Paraffin fumes during agitation *Microwave ovens specially design for tissue processing are now common in recent tissue processing techniques. Self-Contained Fluid Exchange Systems *The penetrative properties of microwave and conversion of this incident energy into heat is made use of this processor so that it shortens the processing time. * The processing time depends on the thickness and density of the specimen. Graded concentration of solutions is not required. Clearing agents are not necessary Xylene and formalin are not used in this process Agitation is by Air-nitrogen system Processed tissue will have: o Better quality epithelium o Less shrinkage of tissue o More focal condensation of stroma * each steps could be customized by controlling the time, the Advantages: temperature or the pressure Increased efficiency through improved turnaround – Microprocessor is used times – Tissues cassettes are loaded into a retort chamber Shorter processing time where they remain stationary throughout the process Environmentally friendly reagents – Reagents and melted paraffin wax moved Greater profitability due sequentially in and out of retort chamber Lesser degree of denaturation of nucleic acids. – Agitation is through tidal action Disadvantages: Advantages: Costly and labor intensive - The solutions are Vacuum and heat can be used at any stage – manually manipulated reduction in processing time and improved filtration Temperature must be maintained between 70 & 85° of denser tissues. Size of the tissue sample is critical (At least 2mm) Comparison Between Tissue Processors B. Tissue Microarray Manual TP Automated TP Microwave TP - Method to evaluate numerous samples of tissue in a Reliability Less reliable as More reliable More reliable short period human error - Use and includes a specimen tracking software may occur system Time Time Havecustomized Shortens the - An ideal for laboratory with a high volume of tissue Consumption consuming schedules for TP processing time microarrays (TMAs) as 120 to 180 cores can be Cost Inexpensive Costly More costly punched per hour. Chemicals Employs Vacuum & heat Not used to *the instruments like Xylene & noxious can be used eliminates toxic marks edits and Formalin chemicals fumes and saves punch carcinogens coordinates using on Graded Monitored Monitored Not required concentration an on screen display of solution and software tools Shrinkage of Evaluated Less Evaluated Lesser tissue Evaluated Rapid Processors With Multi-Sectioned Retorts C. Automated Embedding Section * the tissue is surrounded by a molten medium by which we are using a mold and subsequently this medium is solidified to make a block for cutting thin sections of tissue This processor uses: Microwave technology Aims of embedding: Vacuum infiltration is to give support of the tissue Molecular-friendly* proprietary reagents to preserve the tissue for archive values *A robotic arm moves the tissue cassettes through four stations, and the four stations contains: acetone, isopropanol, Tissue-tek system is the combination of: polyethylene, glycol mineral oil and paraffin. Dispenser of liquid paraffin in a constant temperature – Microwaves and agitation are used to accelerate the A metal plate to make the tissue block diffusion of solvents into the tissue Cold plate – Microwave technology utilize operates at a continuous low power instead of pulsing high levels of microwave energy * Microwave circle around the cavity taking the advantage of the physical principle of the whispering chamber effect that eliminates hot and cold spots Advantages: Acceptance of tissues into the system in every 15 mns Improve turnaround time Reagents use our environmentally safe * the morphology and the quality of the specimen is considered Disadvantages: Costly Crossing of the tissue sample that requires standardization of specimen dissection D. Microtome E. Cryostat * mechanical instrument used to cut biological specimens – a machine in which a slicer called a microtome is into very thin segments and those are used for placed in a freezer the temperature may be regulated microscopic examination between -10 to -40°C Parts: – the first cryostat was introduced in 1954 Base (microtome body) knife attachment and Knife material or tissue holder Can be classified as: Manual Semi-automatic Automatic LASER – Used for precise cutting without actually touching the sample Parts: – This machine enables non-contact slicing without o Cryocabinet causing thermal damage o Microtome – It can cut slices w/ thickness ranging o Knife/blade from 10-100mm o Antiroll plate *This only designed to slice samples with o Specimen holder high precision, noncontact slicing. It is o Fluorescent light lamp equipped with state of the art o Electronic control panel femtosecond laser technology Indications Rapid production of sections for intraoperative Advantages: diagnosis Non-contact processing Immunofluorescence study Sub micrometer precision Diagnostic and research enzymes histochemistry for Cutting the tissue in its labile enzymes native state Diagnostic and research for non-enzyme No thermal damage histochemistry Fewer artifacts Silver demonstration methods, particularly in Less time consumption in tissue preparation neuropathology COMPUTERIZED Advantages: – Is equipped with the advanced rapid thermostatic Both tissue and knife are maintained at same low switch semiconductor freezing cryo scalpel and temperature. cryoplate Capable of slicing sections as thin as one – Can carry out rapid freezing section or routine micrometer. paraffin section Serial sectioning is possible. – Advanced retraction function Automatic defrosting and sterilization. Anti fogging air circulatory system. *makes better sectioning and the retraction value is also adjustable Disadvantages: memorizes course feed and Constant supervision and maintenance of reload function can significantly temperature. improve the cutting efficiency Special lubricants with low congealing point have to be used Freeze artifacts If temperature is too low tissue becomes hard and crumbles difficult to cut Costly F. Water Bath J. Labelling – Used to float the tissue after cutting – The temperature is controlled by a thermostat – The temperature of water in the water bath should be 10° c below the melting point of the embedded paraffin wax and is usually kept in 40 to 50 degrees celsius G. Drying Electrothermal Slide Drying Bench – The small amount of water held under the section will allow further flattening to occur when heat is applied to the dry section – The temperature should be at the melting point of the paraffin – Automated stainers have drying ovens as part of the instrumentation. H. Autostainer Two Types: a) Dips Slides Into The Stain (Linear Design) – one slide at a time – slides are clip to the slide holders which are attached – to a carrier mechanism b) Applies Stains To The Slide (Batch /Carousel Design) – multiple slides slide rocks are moved through baths – of staining solution Capillary Gap Stainer Centrifugal Strainer Flat Stainer Force or draw the Spray the stain as the Drops the stain stain between the slide rotate past the onto the slide, specimen slide and spray nozzle in a while the slide lies another surface spinning chamber flat within the stainer PAP, AFB, Hematology IHC I. Cover Slipping