LEGAL MANDATES RELATED TO NUTRITION AND DIET THERAPY Flashcards
FDA As a regulatory agency under the Department of Health, created under Republic Act No
3720, series of 1963, as amended by Executive Order 175
Food, Drugs and Devices, and Cosmetics Act
Republic Act No. 3720
The Food and Drug Administration Act of 2009
Republic Act No. 9711
mandated to ensure the safety, efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health which require regulations as determined by the FDA
Republic Act No. 9711
The Universally Accessible Cheaper and Quality Medicine Act of 2008
● RA 9502
The Generics Act Of 1988
● RA 6675
The Pharmacy Law
● RA 5921
The Tobacco Regulation Act of 2003
● RA 9211
The Consumer Act of the Philippines
● RA 7394
The Price Act
● RA 7581/10623
The Food Safety Act of 2013
- RA 10611
The ASIN Law
● RA 8172
The Special Law on Counterfeit Drug
● RA 8203
The Food Fortification Law
● RA 8976
The Comprehensive Dangerous Drugs Act
● RA 9165
The Expanded Senior Citizens Act of 2003
● RA 9257
The Household Hazardous Act
● PD No. 881
The Milk Code of the Philippines
EO No. 51
or The Responsible Parenthood and Reproductive Health Bill of 2012
● RA 10354
The Code of Sanitation of the Philippines
● PD 856
To guarantee the safety, quality, purity, efficacy of products in order to protect and promote the right to health of the general public
FDA Mission
Administration to be an internationally recognized center of excellence in health product regulation by 2026. Address:
● Civic Drive Filinvest Corporate City
● Alabang, Muntinlupa City
● Tel. no: +632 8 857-1900
● info@fda.gov.ph
FDA VISION
is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)
The US Department of Health and Human Services (HHS) issued the HIPAA _______to implement the requirements
Privacy Rule
address the use and disclosure of individuals’ health information (known as “protected health information”) by entities subject to the Privacy Rule. These individuals and organizations are called “covered entities.”
● The Privacy Rule standards
contains standards for individuals’ rights to understand and control how their health information is used
Privacy Rule
goal of this is to ensure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public’s health and well-being.
Privacy Rule
Rule strikes a balance that permits important uses of information while protecting the privacy of people who seek care and healing.
Privacy Rule
- Healthcare providers
- Health plans
- Healthcare clearinghouses
- Business associates
Individuals and organizations are subject to the Privacy Rule and considered covered entities
Every healthcare provider, regardless of size of practice, who electronically transmits health information in connection with certain transactions. These transactions include claims, benefit eligibility inquiries, referral authorization requests, and other transactions for which HHS has established standards under the HIPAA Transactions Rule.
- Healthcare providers
Entities that provide or pay the cost of medical care.
- include health, dental, vision, and prescription drug insurers; health maintenance organizations (HMOs); Medicare, Medicaid, Medicare +Choice, and Medicare supplement insurers; and long-term care insurers (excluding nursing home fixed-indemnity policies).
- include employer-sponsored group health plans, government and church-sponsored health plans, and multi-employer health plans.
- Health plans
● Exception: A group with fewer than 50 participants that is administered solely by the employer that established and maintains the plan is not a covered entity.
- Health plans
-Entities that process nonstandard information they receive from another entity into a standard (i.e., standard format or data content), or vice versa.
- will receive individually identifiable health information only when they are providing these processing services to a health plan or healthcare provider as a business associate.
- Healthcare clearinghouses
A person or organization (other than a member of a covered entity’s workforce) using or disclosing individually identifiable health information to perform or provide functions, activities, or services for a covered entity. These functions, activities, or services include claims processing, data analysis, utilization review, and billing.
- Business associates
- Formulate national food and nutrition policies and strategies and serve as the policy, coordinating and advisory body of food, nutrition and health concerns;
- Coordinate planning, monitoring, and evaluation of the national nutrition program;
- Coordinate the hunger mitigation and malnutrition prevention program to achieve relevant Millennium Development Goals;
NATIONAL NUTRITION COUNCIL FUNCTIONS
- Strengthen competencies and capabilities of stakeholders through public education, capacity building and skills development;
- Coordinate the release of funds, loans, and grants from government organizations (GOs) and nongovernment organizations (NGOs); and
- Call on any department, bureau, office, agency and other instrumentalities of the government for assistance in the form of personnel, facilities and resources as the need arises.
NATIONAL NUTRITION COUNCIL FUNCTIONS
Creation of the Philippine Institute of Nutrition (PIN) as a first attempt to institutionalize a national nutrition program
● 1947
Reorganization of the PIN into the Food and Nutrition Research Center (FNRC) under the National Science and Development Board
● 1958
Organization of the National Coordinating Council on Food and Nutrition (NCCFN), a loose organization of government and non-government agencies and organizations involved in nutrition and related projects.
● 1960
Promulgation of Executive Order No. 285, mandating the National Food and Agriculture Council (NFAC) to coordinate nutrition programs in addition to coordinating national food programs, thus, superseding the NCCFN.
● 1971
Promulgation of Presidential Decree No. 491 (Nutrition Act of the Philippines, 25 June 1974), which created the National Nutrition Council (NNC) as the highest policy-making and coordinating body on nutrition.
● 1974
Promulgation of Executive Order No. 234 (Reorganization Act of NNC, 22 July 1987) reaffirming the need for an intersectoral national policy-making and coordinating body on nutrition. It expanded the membership of the NNC to include the Departments of Budget and Management (DBM), Labor and Employment (DOLE), Trade and Industry (DTI), and National Economic and Development Authority (NEDA). The Department of Social Welfare and Development was named chair of the NNC Governing Board.
● 1987
Administrative Order No. 88 named the Department of Agriculture as the NNC Chair of the NNC Governing Board
● 1988
Executive Order No. 472 named the Department of Health (DOH) as the chair of the NNC, with the Department of Agriculture (DA) and the Interior of Local Government (DILG) as vice-chairs. In addition to its policy and coordinating functions, NNC was also tasked to focus on hunger-mitigation and authorized to generate and mobilize resources for nutrition and hunger-mitigation programs
● 2005
Executive Order No. 616 designated the NNC as oversight of the Accelerated Hunger-Mitigation Program to ensure that hunger-mitigation measures are in place, and are reported to the President.
● 2007
