#Discuss the significance and importance of gaining knowledge regarding the legal mandates of

nutrition and diet therapy in the philippines in relation to nursing profession

LEGAL MANDATES RELATED TO NUTRITION AND DIET THERAPY FOOD AND DRUG ADMINISTRATION

FOOD AND DRUG ADMINISTRATION RA 9711 - “The Food and Drug Administration (FDA) Act of
2009.The FDA Act of 2009 created the Food and Drug Administration (FDA) in the Department of Health
(DOH) to be headed by a Director General with the rank of Undersecretary of Health. Major Aims of the
FDA Act • To protect and promote the right to health of the Filipino people • To establish and maintain
effective health products regulatory system Important Definitions in the FDA Act • “Health products”
means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and
household/urban hazardous substances and/or a combination of and/or a derivative thereof. It shall
also refer to products that may have an effect on health which require regulations as determined by the
FDA. •“Device” means medical devices, radiation devices and health-related devices.

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, intended to address
potential threats to patient privacy posed by the computerization and standardization of medical
records, provides a new poor level of federal protect on for health information. The Privacy Rule limits
the circumstances under which Covered Entities can use or disclose protected health information (PHI),
requiring, with some exceptions, authorization from the patient to permit uses and disclosures of PHI
fore search. “Health information” is defined as “any information, whether oral or recorded in any form
or medium, that: 1) is created or received by a health care provider, health plan, public health authority,
employer, life insurer, school or university, or health care clearinghouse; and 2) relates to the past,
present, or future physical or mental health or condition of an individual, the provision of health care to
an individual, or the past, present, or future payment for the provision of health care to an individual.”
“Individually identifiable” refers to information collected from an individual that identities him or her or
for which there is a “reasonable basis” to believe the information could be used to identify the
individual. The definition of PHI excludes individually identifiable health information contained in certain
educational or employment records. The Privacy Rule regulates the use and disclosure of PHI by Covered
Entities. Covered Entities are health plans (health insurers), healthcare clearinghouses (entities that
receive healthcare transactions from providers or others, translate the data into a form acceptable to
the payor, and forward the processed transaction to payors and clearinghouses), and healthcare
providers (hospitals and physicians that transmit health information in connection with a specified
transaction).

The National Nutrition Council Governing Board (NNC GB) chaired by Health Secretary and Chairperson
Francisco T. Duque III approved during its meeting on 21 June 2018 the Policy Statement on Fad Diets, as
explained in the NNC Governing Board Resolution No. 4 Series of 2018. This is to address the issue of the
proliferation of fad diets which is growing in popularity among Filipinos interested in losing weight. The
policy declares that the NNC does not recommend the use of fad diets for weight loss as it may pose
potential health risk and dangers. Instead, the NNC recommends the adherence to a holistic,
sustainable, adequate, and nutritionally-balanced diet, complemented by an active lifestyle and lifelong
behavioral modifications. Moreover, to prevent further increase of overweight and obesity prevalence in
the Philippines, the NNC Governing Board also asserts that population-based interventions, particularly
through the promotion of healthier food environments and systems, as well as public awareness
through behavioral change, should complement individual efforts to combat overweight and obesity.
 #Download 2 related article showing relationship, innovation and application of Nutrition and

Dietetics in the improvement of human life in relation to Human Genomics, Ethico-moral

principles, End-of Life care, Cultural diversities and Religion.

1.) Leveraging Trends in Biomedical Science in Nutrition-Based Health Care

Schork identified four trends in today’s biomedical science that he believes could be leveraged in
nutrition-based health care: (1) personalized health care; (2) a number of emerging technologies that
could facilitate personalized health care, such as DNA sequencing, proteomics, wireless technologies,
and novel imaging technologies; (3) big data and the use of information technology to identify patterns
in the massive amounts of data that are being collected at the population level; and (4) emerging
strategies in artificial intelligence. He identified as the goal for nutrition-based health

3 Schork was chair of the planning committee for the 2006 National Academies workshop on
nutrigenomics (IOM, 2007). The workshop summary is available at https://www.nap.edu/catalog/11845
(accessed March 23, 2018). Suggested Citation:"5 Nutrigenomics: Regulatory, Ethical, and Science Policy
Considerations." National Academies of Sciences, Engineering, and Medicine. 2018. Nutrigenomics and
the Future of Nutrition: Proceedings of a Workshop. Washington, DC: The National Academies Press.
care combining these trends such that something compelling can be said about the nutritional needs of
individuals.

However, Schork continued, these trends also raise some questions, beginning with what he termed the
“garbage in, garbage out principle”: that unless data are of sufficient quality, an analysis of those data
will not yield reliable results. In the context of vetting nutritional strategies, he elaborated, a number of
questions need to addressed, including how to develop these strategies in the first place, how to test
them in humans, and how to deploy them at the population level. Additionally, he raised the question of
what these nutritional strategies are trying to optimize—individual outcomes; cost savings for the
community as a whole, such as by reducing the incidence of disease in the population at large; or quality
of life. He encouraged the workshop participants to keep these questions mind as he proceeded and
suggested that they could shed light on some of the controversies he would be describing.

In addition to these emerging trends in biomedical science, Schork mentioned recent, relevant changes
at the U.S. Food and Drug Administration (FDA). He predicted that some of these changes will bear on
the claims one can make in the future about nutritional interventions. Specifically, he was referring to
the 21st Century Cures Act, signed into law by President Obama in December 2016, which under certain
conditions allows companies to provide “data summaries” and “real-world evidence,” such as results of
observational studies, insurance claims data, patient input, and anecdotal data, rather than full clinical
trial results (FDA, 2017a). The data must be compelling and collected in a sophisticated way, although
definitions of “compelling” have yet to be proposed. Nonetheless, Schork characterized this as “a
complete game changer.” He noted that FDA has issued a number of white papers on various aspects of
this new legislation that he thinks may be worthy of consideration by nutritional scientists.
National Academies of Sciences, Engineering, and Medicine. 2018. Nutrigenomics and the Future of
Nutrition: Proceedings of a Workshop. Washington, DC: The National Academies Press.
https://doi.org/10.17226/25147.

2.) Federal Legal Framework for Health-Related Genetic Testing

Roller explained that all laboratories that perform health-related testing, including genetic testing, are
subject to federal regulatory standards administered by the Centers for Medicare & Medicaid Services
(CMS) under the Clinical Laboratory Improvement Amendments (CLIA). These standards, she noted,
govern how tests are performed, the qualification of laboratory personnel, and quality control
procedures for each laboratory. She added that they are designed to ensure the analytical validity, but
not the clinical validity, of genetic testing in laboratories that perform health-related testing.

In contrast, Roller continued, FDA regulates genetic testing kits and components that are sold to clinical
laboratories or other persons under the Federal Food, Drug and Cosmetic Act (FDCA), which requires
that products be cleared by FDA before marketing. In accordance with the definition of “device” in the
statute, FDA’s authority to regulate medical devices covers in vitro reagents and any genetic testing kit
or related article that is intended for use in the diagnosis of disease or other conditions or in the cure,
mitigation, treatment, or prevention of disease. Roller noted that, while there is some controversy
concerning the precise scope of FDA’s authority to regulate tests that are developed in house by
laboratories (i.e., laboratory-developed tests, or LDTs), FDA has taken the legal position that laboratories
offering LDTs are subject to both the CLIA and the FDCA, yet FDA has generally exercised enforcement
discretion and refrained from enforcing the pre-market clearance requirements for LDTs.

Roller went on to point out that in 2015, FDA issued a report on its findings from an evaluation of 20
publicly available case studies involving what it called “problematic LDTs,” including some genetic tests
(FDA, 2015). According to Roller, none of the problematic LDTs appeared to have been related to
nutrigenomics, but among those 20 cases, FDA identified a number of critical issues posed by LDTs that
had not been cleared by the agency, including lack of evidence supporting clinical validity, lack of pre-
market review of performance data, and unsubstantiated product claims. In the specific context of
genetic tests, she reported, FDA found that some tests yielded too many false positives and others too
many false negatives, some detected factors that had no clear relevance to the disease at issue, some
linked to treatments that were based on disproven scientific Suggested Citation:"5 Nutrigenomics:
Regulatory, Ethical, and Science Policy Considerations." National Academies of Sciences, Engineering,
and Medicine. 2018. Nutrigenomics and the Future of Nutrition: Proceedings of a Workshop.
Washington, DC: The National Academies Press.concepts, and others had problems with lack of
validation. She pointed out that all of these 20 problematic LDTs had met the minimum CLIA standards.

Roller emphasized that only health-related genetic tests qualify as medical devices. So, for example,
Helix’s many applications, which she noted that Janssens had also mentioned during her presentation (in
the context of her discussion of the contrast between companies’ claims and disclaimers about the
genetic tests they are selling), are classified as entertainment applications of genetic testing. To illustrate
this point, Roller observed that through Helix, one can order genetic testing to gain insight into the types
of wine one is likely to prefer based on taste preference, how much “the Neanderthal genome” is
reflected in one’s own genome, or whether one’s metabolism is more farmer or hunter based. She
added that consumers can even purchase socks, scarves, or tartans that are color-coded to reflect their
personal genetic profile. Because these are not health applications, she reiterated, they do not qualify as
medical devices, so FDA does not have jurisdiction to regulate the tests involved under the medical
device provisions of the FDCA. https://www.scribd.com/document/479343097/LEGAL-MANDATES-
RELATED-TO-NUTRITION-AND-DIET-THERAPY-docx

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