Public Health Activities HIPAA Exception definition

Public Health Activities HIPAA Exception means that certain exception in 45 C.F.R. § 164.512(b)(1)(iii), which allows a covered entity (e.g., a pharmacy) to disclose Patient Confidential Information to an entity that is subject to the jurisdiction of the FDA. Specifically, the exception is available for disclosures by a covered entity for a “public health activity” to an entity subject to the jurisdiction of the FDA with respect to an FDA-regulated product or activity. Pursuant to the “public health activity” requirement, the disclosure must be made for the purpose of activities related to the quality, safety, or effectiveness of an FDA-regulated product, rather than merely the commercial purposes of the manufacturer. Also, the minimum necessary standard under HIPAA applies to such public health disclosures.
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Public Health Activities HIPAA Exception means that certain exception in 45 C.F.R. § 164.512(b)(1)(iii), which allows a covered entity (e.g., a pharmacy) to disclose Patient Confidential Information to an entity that is subject to the jurisdiction of the FDA. Specifically, the exception is available for disclosures by a covered entity for a “public health activity” to an entity subject to the jurisdiction of the FDA with respect to an FDA-regulated product or activity. Pursuant to the “public health activity” requirement, the disclosure must be made for the purpose of activities related to the quality, safety, or effectiveness of an FDA-regulated product, rather than merely the commercial purposes of the manufacturer. Also, the minimum necessary standard under HIPAA applies to such public health disclosures. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
Public Health Activities HIPAA Exception means that certain exception in 45 C.F.R. § 164.512(b)(1)(iii), which allows a covered entity (e.g., a pharmacy) to disclose Patient Confidential Information to an entity that is subject to the jurisdiction of the FDA. Specifically, the exception is available for disclosures by a covered entity for a “public health activity” to an entity subject to the jurisdiction of the FDA with respect to an FDA-regulated product or activity. Pursuant to the “public health activity” requirement, the disclosure must be made for the purpose of activities related to the quality, safety, or effectiveness of an FDA-regulated product, rather than merely the commercial purposes of the manufacturer. Also, the minimum necessary standard under HIPAA applies to such public health disclosures.Page 3 of 24 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1

Examples of Public Health Activities HIPAA Exception in a sentence

  • The Data may include Patient Confidential Information (which is intended to be used by Jazz Pharmaceuticals in a manner consistent with Public Health Activities HIPAA Exception).

Related to Public Health Activities HIPAA Exception

  • Public health means the level of well-being of the general

  • Public health emergency means an emergency with respect to COVID–19 declared by a Federal, State, or local authority.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Substance Abuse Professional (SAP) means a qualified person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.

  • Imminent danger to the health and safety of the public means the existence of any condition or practice, or any violation of a permit or other requirement of this chapter in a surface coal mining and reclamation operation, which condition, practice, or violation could reasonably be expected to cause substantial physical harm to persons outside the permit area before such condition, practice, or violation can be abated. A reasonable expectation of death or serious injury before abatement exists if a rational person, subjected to the same conditions or practices giving rise to the peril, would not expose the person's self to the danger during the time necessary for abatement.

  • Health Insurance Portability and Accountability Act means the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936, as amended.

  • Chemical dependency professional means a person certified as a chemical dependency professional by the department of health under chapter 18.205 RCW.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and other provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or byproducts, asbestos, polychlorinated biphenyls, noise or radiation, each as amended and as now or hereafter in effect.

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Spatial Planning and Land Use Management Act means the Spatial Planning and Land Use Management Act, 2013 (Act 16 of 2013);

  • Clean air standards, as used in this clause, means:

  • Basic health plan means the plan described under chapter

  • POPI Act means the Protection of Personal Information Act 4 of 2013 as may be amended from time to time;

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Basic health benefit plan means any plan offered to an individual, a small group,

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • Environmental, Health and Safety Liabilities means any cost, damages, expense, liability, obligation or other responsibility arising from or under Environmental Law or Occupational Safety and Health Law and consisting of or relating to:

  • Cosmetology means any one and/or combination of practices generally and usually performed by and known as the occupation of beauty culturalist, cosmeticians, cosmetologists or hairdressers or any person holding him or herself out as practicing cosmetology in or upon a place or premises. Cosmetology shall include, but otherwise not be limited to, the following: embellishing, arranging, dressing, curling, waving, cleansing, beautifying, cutting, singeing, bleaching, coloring, or similar work upon the hair of any person by any means and with hands or mechanical or electrical apparatuses, devices or appliances or by use of cosmetic preparations, antiseptics, tonics, lotions, creams or otherwise, massaging, cleansing, stimulating, manipulating, exercising, beautifying or similar work, the scalp, face, neck, arms, hands, bust or upper part of the body, or manicuring, pedicuring or sculpting the nails of any person.

  • Public highway means a public highway, road, street, avenue, alley, or thoroughfare of any kind, or a bridge, tunnel, or subway used by the public.

  • Natural background means the condition of waters in the absence of man-induced alterations based on the best scientific information available to the Department. The establishment of natural background for an altered waterbody may be based upon a similar unaltered waterbody or on historical pre-alteration data. 62-302.200(15), FAC.

  • Substance use disorder professional means a person

  • HITECH Act means the Health Information Technology for Economic and Clinical Health Act, TitleXIII, Subtitle D, Part 1 & 2 of the American Recovery and Reinvestment Act of 2009.

  • Qualified mental health professional means a licensed medical practitioner or any other person meeting the qualifications specified in OAR 309-019-0125.

  • Lawn and garden insecticide means an insecticide product labeled primarily to be used in household lawn and garden areas to protect plants from insects or other arthropods. Notwithstanding the requirements of section 6(c) aerosol “Lawn and Garden Insecticides” may claim to kill insects or other arthropods.