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.
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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).

  • Jazz Pharmaceuticals will restrict access and use to such disclosed Patient Confidential Information to those employees and agents who are necessary to further the intended purpose related to the Public Health Activities HIPAA Exception.

Related to Public Health Activities HIPAA Exception

  • Public Health Laws means all applicable Laws relating to the development, pre-clinical testing, clinical testing, manufacture, production, analysis, distribution, importation, exportation, use, handling, quality, sale or promotion of any drug, biologic or medical device (including any ingredient or component of the foregoing products) intended for any medical or clinical use subject to regulation under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) or similar federal, state or foreign Laws.

  • 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 article, in a surface coal mining and reclamation operation which 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 himself 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, and ordinances 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, as such requirements are enacted and in effect on or prior to the Closing Date.

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

  • 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;

  • 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 any Environmental Law.

  • Cosmetology means the art or practice of embellishment, cleansing, beautification, and styling of hair, wigs, postiches, face, body, or nails.

  • 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.

  • Autism spectrum disorders means any of the pervasive developmental disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, published by the American Psychiatric Association, including autistic disorder, Asperger's disorder and pervasive developmental disorder not otherwise specified.

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);