Healthcare Regulation definition

Healthcare Regulation means any law, statute, ordinance, rule, regulation, order, decree, or requirement of any court or governmental agency or body having jurisdiction over the Company or any of its properties relating to the healthcare industry, such as healthcare crimes, pre-clinical and clinical testing, manufacture, safety, efficacy, labeling, storage and record keeping, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act; (ii) any applicable healthcare regulation; or (iii) applicable state privacy or confidentiality laws relating to the maintenance of patient healthcare information.
Healthcare Regulation means any law, statute, ordinance, rule, regulation, order, decree, or requirement of any court or governmental agency or body having jurisdiction over the Company or any of its properties relating to the healthcare or medical device industry, such as healthcare crimes, pre-clinical and clinical testing, design, manufacture, safety, quality, efficacy, labeling, storage, record keeping, post market reporting, pre-market approval, and advertising and promotion of medical devices, including but not limited to: (i) the Federal Food, Drug and Cosmetic Act, (ii) any applicable foreign healthcare regulation, (iii) the federal Anti-Kickback Statute and similar state laws relating to payments under medical healthcare programs, (iv) the Health Insurance Portability and Accountability Act of 1996, (v) applicable state privacy or confidentiality laws relating to the maintenance of patient healthcare information, or (vi) the False Claims Act.

Examples of Healthcare Regulation in a sentence

  • The pledge of the Pledged Collateral pursuant to the Collateral Documents does not violate Regulation T, U or X of the Board of Governors of the Federal Reserve System or the terms or conditions of any Healthcare Authorization or Healthcare Regulation.

  • Fraud and Abuse and Other Healthcare Regulation Anti-Kickback Statute We are subject to various federal and state healthcare laws, including, but not limited to, anti- kickback laws.

Related to Healthcare Regulation

  • Medicare Regulations means, collectively, all federal statutes (whether set forth in Title XVIII of the Social Security Act or elsewhere) affecting the health insurance program for the aged and disabled established by Title XVIII of the Social Security Act and any statutes succeeding thereto; together with all applicable provisions of all rules, regulations, manuals and orders and administrative, reimbursement and other guidelines having the force of law of all Governmental Authorities (including without limitation, Health and Human Services ("HHS"), HCFA, the Office of the Inspector General for HHS, or any Person succeeding to the functions of any of the foregoing) promulgated pursuant to or in connection with any of the foregoing having the force of law, as each may be amended, supplemented or otherwise modified from time to time.

  • Healthcare Laws means all Laws of any Jurisdiction relating to the governance or provision of healthcare services or the operation of healthcare facilities, and any rules and regulations adopted and publications promulgated pursuant thereto, including, without limitation, any Laws, rules and regulations relating to obtaining or the maintenance of certificates of need, licenses, permits, authorizations, certificates, and the unauthorized practice of medicine.

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • Healthcare services means services or goods provided for

  • Federal Health Care Program means a Federal health care program as defined in section 1128B(f) of the Social Security Act, and includes Medicare, Medicaid, and CHIP.

  • Health Care Authority or “HCA” means the Washington State Health Care Authority, any division, section, office, unit or other entity of HCA, or any of the officers or other officials lawfully representing HCA.

  • Healthcare provider means any person or entity including a hospital, physician or a network of providers that provided healthcare services and/or treatments to or on behalf of a Settlement Program Claimant.

  • EU Regulation means a regulation within the meaning of Article 288 of the Treaty on the Functioning of the European Union;

  • Market Abuse Regulation means the EU Market Abuse Regulation (596/2014).

  • Health Care Law means any Applicable Law regulating the acquisition, construction, operation, maintenance or management of a health care practice, facility, provider or payor, including without limitation, 42 U.S.C. ss.1395nn and 42 U.S.C. ss. 1320a-7b.

  • Healthcare shall have the meaning set forth in the introductory paragraph hereof.

  • Health Care Laws means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated pursuant to such statutes; (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) any and all other applicable health care laws and regulations. Neither the Company nor, to the knowledge of the Company, any subsidiary has received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, to the knowledge of the Company, any subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor any of its respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

  • Land Use Regulations means all ordinances, resolutions and codes adopted by the City governing the development and use of land, including the permitted use of land, the density or intensity of use, subdivision requirements, the maximum height and size of proposed buildings, the provisions for reservation or Dedication of land for public purposes, and the design, improvement and construction and initial occupancy standards and specifications applicable to the Development of the Property. “Land Use Regulations” do not include any City or City-agency ordinance, resolution or code governing any of the following:

  • Health care means any of the following intended for use in the diagnosis, treatment, mitigation, or prevention of a human ailment or impairment:

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • Health Care Operations shall have the meaning given to such term under the HIPAA 2 Privacy Rule in 45 CFR § 164.501.

  • Health care services means services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease.

  • Health care organization ’ means any person or en-