Health Care Regulatory Laws means any applicable law relating to healthcare, including, without limitation the following (as amended from time to time), (i) the Federal Food, Drug, and Cosmetic Act of 1938, as amended (21 U.S.C. § 301 et seq.), and (ii) the Public Health Service Act (42 U.S.C. § 201 et seq.), and all regulations promulgated thereunder (including, but not limited to, 21 C.F.R. Part 1271).
Health Care Regulatory Laws means any applicable Law relating to healthcare, including, without limitation the following (as amended from time to time), in each case, only to the extent applicable to the business of Clearday or its Subsidiaries as conducted on the date of this Agreement and on the Effective Date, (i) those relating to Medicare or Medicaid, (ii), the Federal Food, Drug and Cosmetic Act of 1938, as amended, and all regulations promulgated thereunder by the U.S. Food and Drug Administration (“FDA”) (the “FDCA”), (iii) HIPAA, and other Privacy Laws concerning Personal Data in medical records and/or other records generated in the course of providing or paying for health care services, (iv) the Anti-Kickback Law (42 U.S.C. § 1320a-7b(b)) and the regulations promulgated thereunder, (v) the Civil Monetary Penalties Act (including those aspects pertaining to beneficiary inducements) (42 U.S.C. § 1320a-7a) and the regulations promulgated thereunder, (vi) the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), (vii) the federal physician self-referral prohibition (42 U.S.C. § 1395nn) and the regulations promulgated thereunder, (viii) the False Claims Act (31 U.S.C. § 3729 et seq.), (ix) the Federal Health Care Fraud Law (18 U.S.C. § 1347), (x) state Laws relating to health care fraud and abuse and financial relationships between referral sources for health care items and services and referral recipients; (xi) other federal or state Laws relating to billing or claims for reimbursement for health care items and services submitted to any third-party payor, (xii) the Controlled Substances Act (21 U.S.C. § 801 et seq.) (xiii) the Public Health Service Act (42 U.S.C. § 201 et seq.) , (xiv) federal and state Laws related to the wholesale distribution of health care items including without limitation the Prescription Drug Marketing Act (21 U.S.C. §353) and the regulations promulgated thereunder, (xv) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder, (xvi) the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), and (xvii) federal, state and local Laws regulating the corporate practice of medicine, professional fee-splitting, or the health care licensure of health care businesses.
Health Care Regulatory Laws means the federal Medicare and Medicaid statutes (which include, but are not limited to, 42 U.S.C. ss.ss.1320a-7, 1320a-7a, 1320a-7b, 1395nn), the federal TRICARE statute, the Federal False Claims Act (31 U.S.C. ss.3729-33), 18 U.S.C. ss.1892, 18 U.S.C. ss.1341, 18 U.S.C. ss.1343, 18 U.S.C. ss.ss.1961-63, 18 U.S.C. ss.286, 18 U.S.C. ss.1001, 18 U.S.C. ss.664, 18 U.S.C. ss.666, 18 U.S.C. ss.1510, 18 U.S.C. ss.1516, 18 U.S.C. ss. 1347, 18 U.S.C. ss.669, 18 U.S.C. ss.1035, 18 U.S.C. ss.1518, 31 U.S.C. ss.3730, and, with respect to each of the above, any ordinance, rule, regulation or Order, all federal Laws regulating prescription drug and controlled substance sale, use, distribution, marketing and security; all federal Laws pertaining to human subjects research; Laws pertaining to precautions against the spread of bloodborne pathogens in the workplace or healthcare facilities; and all federal Laws pertaining to the licensure and operation of managed care plans and health plans offering health services under Title XIX of the Social Security Act. Health Care Regulatory Laws shall also mean, with respect to any applicable state, the state Laws pertaining to substantially similar subject matter, as well as any state Laws pertaining to the practice of medicine or the allied health professions.
Examples of Health Care Regulatory Laws in a sentence
Except as set forth in Schedule 2.27(a) of the Company Schedules, neither the Company, any Subsidiary, or any Affiliate thereof has received any written or oral notice or complaint from a Governmental Entity or any other Person, that allege that the Company or such Subsidiary is not in compliance with any such Health Care Regulatory Laws and that have not been addressed to the satisfaction of such Governmental Entity or complainant.
Except as set forth in Schedule 2.27(a) of the Company Schedules, the Company and each Subsidiary is operating and has operated in material compliance with the Health Care Regulatory Laws.
The Company has not received notice of adverse finding, warning letter, or clinical hold notice from an IRB, IEC, FDA, EMEA, or similar Governmental Entity, or any untitled letter or other correspondence or notice from the FDA or any other Governmental Entity or any institutional or ethical review board alleging or asserting noncompliance with any Health Care Regulatory Laws applicable in any jurisdiction.
Neither the Company nor any Subsidiary has been the subject of or received, or has knowledge of any pending or, to the Company’s knowledge, threatened: (i) compliance, disciplinary or enforcement action from any Governmental Entity; (ii) any written notice of noncompliance with or alleged violation of any Health Care Regulatory Laws; or (iii) material finding from an inspection by a Governmental Entity.
For the last three (3) years, neither the Company nor any Subsidiary has received written notice of, and there is no pending, or to the knowledge of the Company, threatened action, suit, proceeding, injunction or investigation against the Company or any of its Subsidiaries by any Governmental Authority or other Person asserting a material lack of compliance with any Health Care Regulatory Laws.
More Definitions of Health Care Regulatory Laws
Health Care Regulatory Laws means any applicable Law relating to healthcare, including, without limitation the following (as amended from time to time), (i) those relating to Medicare or Medicaid or any other health benefit programs that are sponsored by a Governmental Authority, including Medicaid managed care, the TRICARE program, worker’s compensation and Medicare Advantage, (ii), the Federal Food, Drug, and Cosmetic Act of 1938, as amended, and all regulations promulgated thereunder by the U.S. Food and Drug Administration, (iii) HIPAA and other Privacy Laws concerning Personal Data in medical records and/or other records generated in the course of providing or paying for health care services, (iv) the Anti-Kickback Law (42 U.S.C. § 1320a-7b(b)) and the regulations promulgated thereunder, (v) the Civil Monetary Penalties Act (including those aspects pertaining to beneficiary inducements) (42 U.S.C. § 1320a-7a) and the regulations promulgated thereunder, (vi) the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812) and the regulations promulgated thereunder, (vii) the federal physician self-referral prohibition (42 U.S.C. § 1395nn) and the regulations promulgated thereunder, (viii) the False Claims Act (31 U.S.C. § 3729 et seq.), and the Federal Health Care Fraud Law (18 U.S.C. § 1347) and the regulations promulgated thereunder, (ix) state Laws relating to health care or insurance fraud and abuse and financial relationships between referral sources for health care items and services and referral recipients, (x) other federal or state Laws relating to billing or claims for reimbursement for health care items and services submitted to any third-party payor, (xi) the Controlled Substances Act (21 U.S.C. § 801 et seq.), (xii) the Public Health Service Act (42 U.S.C. § 201 et seq.), (xiii) federal and state Laws related to the wholesale distribution of health care items including without limitation the Prescription Drug Marketing Act (21 U.S.C. §353) and the regulations promulgated thereunder, (xiv) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder, (xv) the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), (xvi) federal, state and local Laws regulating the corporate practice of medicine, pharmacy, and other licensed healthcare professions, the employment of licensed professionals by non-profe...
Health Care Regulatory Laws means any applicable Law relating to healthcare, including, without limitation the following (as amended from time to time), (i) those relating to Medicare or Medicaid, (ii), the Federal Food, Drug and Cosmetic Act of 1938, as amended, and all regulations promulgated thereunder by the U.S. Food and Drug Administration (“ FDA ”) (the “ FDCA ”), (iii) HIPAA, and other Privacy Laws concerning Personal Data in medical records and/or other records generated in the course of providing or paying for health care services, (iv) the Anti-Kickback Law (42 U.S.C. § 1320a-7b(b)) and the regulations promulgated thereunder, (v) the Civil Monetary Penalties Act (including those aspects pertaining to beneficiary inducements) (42 U.S.C. § 1320a-7a) and the regulations promulgated thereunder, (vi) the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), (vii) the federal physician self-referral prohibition (42U.S.C. § 1395nn) and the regulations promulgated thereunder, (viii) the False Claims Act (31 U.S.C. § 3729 et seq .), (ix) the Federal Health Care Fraud Law (18U.S.C. § 1347), (x) state Laws relating to health care fraud and abuse and financial relationships between referral sources for health care items and services and referral recipients; (xi) other federal or state Laws relating to billing or claims for reimbursement for health care items and services submitted to any third-party payor, (xii) the Controlled Substances Act (21 U.S.C. § 801 et seq. ) (xiii) the Public Health Service Act (42 U.S.C. § 201 et seq.) , (xiv) federal and state Laws related to the wholesale distribution of health care items including without limitation the Prescription Drug Marketing Act (21 U.S.C. §353) and the regulations promulgated thereunder, (xv) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder, (xvi) the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), and (xvii) federal, state and local Laws regulating the corporate practice of medicine, professional fee-splitting, or the health care licensure of health care businesses.
Health Care Regulatory Laws means any Law relating to healthcare or pharmaceutical product or ingredient manufacturing, importation, exportation, sales, advertising, and formulation, including, without limitation the following, (i) those relating to Medicare, Medicaid or provincial and territorial health care insurance plans and programs, including all information and formal guidance and codes of conduct issued by Governmental Authorities related thereto, (ii), the Federal Food, Drug and Cosmetic Act of 1938, as amended, and all informal and formal guidance issued by the U.S. Food and Drug Administration (“FDA”) pursuant thereto (the “FDCA”), (iii) the Food and Drugs Act (Canada), the regulations promulgated thereunder, and all information and formal guidance issued by Health Canada related thereto, (iv) HIPAA, and all federal and state Laws concerning privacy, security or confidentiality of “Personal Information” (or similar terms such as “Personally Identifiable Information”, as defined by applicable state and federal Laws), medical records and/or other records generated in the course of providing or paying for health care services, patient confidentiality and informed consent, and the regulations promulgated thereunder, including all applicable Privacy Laws, (v) the Anti-Kickback Law (42 U.S.C. § 1320a-7b, 42 C.F.R. § 1001.952) and any equivalent or similar Canadian provincial and territorial Laws applicable to health professionals, (vi) the Civil Monetary Penalties Act (including those aspects pertaining to beneficiary inducements) (42 U.S.C. § 1320a-7a, and the regulations promulgated pursuant to such statutes), (vii) the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), (viii) the federal physician self-referral prohibition (42 U.S.C. § 1395nn, 42 C.F.R. § 411.351 et seq.), (ix) the False Claims Act (31 U.S.C. § 3729 et seq.) and the Public Servants Disclosure Protection Act (Canada), (x) the Federal Health Care Fraud Law (18 U.S.C. § 1347), (xi) applicable state, provincial and territorial Laws relating to health care fraud and abuse and financial relationships between referral sources and referral recipients; (xii) other federal, provincial, territorial or state Laws relating to billing or claims for reimbursement submitted to any third-party payor, (xiii) the Controlled Substances Act and the Controlled Drugs and Substances Act (Canada), each as amended, (ix) the Public Health Service Act and the Quarantine Act (Canada), (xv) the federal Controlled Substances Act (2...
Health Care Regulatory Laws means any applicable Law relating to healthcare, including, without limitation the following (as amended from time to time), (i) those relating to Medicare or Medicaid, (ii), the Federal Food, Drug and Cosmetic Act of 1938, as amended, and all regulations promulgated thereunder by the U.S. Food and Drug Administration (“FDA”) (the “FDCA”), (iii) HIPAA, and other Privacy Laws concerning Personal Data in medical records and/or other records generated in the course of providing or paying for health care services, (iv) the Anti-Kickback Law (42 U.S.C. § 1320a-7b(b)) and the regulations promulgated thereunder, (v) the Civil Monetary Penalties Act (including those aspects pertaining to beneficiary inducements) (42 U.S.C. § 1320a-7a) and the regulations promulgated thereunder, (vi) the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), (vii) the federal physician self-referral prohibition (42 U.S.C. § 1395nn) and the regulations promulgated thereunder, (viii) the False Claims Act (31 U.S.C. § 3729 et seq.), (ix) the Federal Health Care Fraud Law (18 U.S.C. § 1347), (x) state Laws relating to health care fraud and abuse and financial relationships between referral sources for health care items and services and referral recipients; (xi) other federal or state Laws relating to billing or claims for reimbursement for health care items and services submitted to any third-party payor, (xii) the Controlled Substances Act (21 U.S.C. § 801 et seq.) (xiii) the Public Health Service Act (42 U.S.C. § 201 et seq.) , (xiv) federal and state Laws related to the wholesale distribution of health care items including without limitation the Prescription Drug Marketing Act (21 U.S.C. §353) and the regulations promulgated thereunder, (xv) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder, (xvi) the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), and (xvii) federal, state and local Laws regulating the corporate practice of medicine, professional fee-splitting, or the health care licensure of health care businesses.
Health Care Regulatory Laws means the federal Medicare and Medicaid statutes (which include, but are not limited to, 42 U.S.C. Sections 1320a-7, 1320a-7a, 1320a-7b, 1395nn), the federal TRICARE statute, the Federal False Claims Act (31 U.S.C. Sections 3729-33), 18 U.S.C. Section 1892, 18 U.S.C. Section 1341, 18 U.S.C. Section 1343, 18 U.S.C. Sections 1961-63, 18 U.S.C. Section 286, 18 U.S.C. Section 1001, 18 U.S.C. Section 664, 18 U.S.C. Section 666, 18 U.S.C. Section 1510, 18 U.S.C. Section 1516, 18 U.S.C. Section 1347, 18 U.S.C. Section 669, 18 U.S.C. Section 1035, 18 U.S.C. Section 1518, 31 U.S.C. Section 3730, and, with respect to each of the above, any ordinance, rule, regulation or order, all federal Laws regulating prescription drug and controlled substance sale, use, distribution, marketing and security; all federal Laws pertaining to human subjects research; Laws pertaining to precautions against the spread of bloodborne pathogens in the workplace or healthcare facilities; and all federal Laws pertaining to the licensure and operation of managed care plans and health plans offering health services under Title XIX of the Social Security Act. Health Care Regulatory Laws shall also mean, with respect to any applicable state, the state Laws pertaining to substantially similar subject matter, as well as any state Laws pertaining to the practice of medicine or the allied health professions.
Health Care Regulatory Laws means the following federal and state Laws and all applicable regulations promulgated thereunder, relating to the regulation, provision or administration of, or payment for, health care benefits, health care insurance coverage and health care products or services: (a) Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); (b) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute) and state Medicaid Laws; (c) the Federal Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn (the Xxxxx Law) or any state law affecting self-referrals; (d) TRICARE, 10 U.S.C. § 1071 et seq.; (e) the Federal Health Care Program Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x) or any state anti-kickback prohibition; (f) the Federal False Claims Act, 31 U.S.C. §§ 3729-3733 or any state law false claims prohibitions; (g) the Federal Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; (h) the Federal Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; (i) state fee-splitting and corporate practice of medicine Laws; (j) any state or federal licensure, permit or authorization Laws relating to the regulation, provision, or administration of, or billing or payment for, health care products or services including, without limitation, any state licensure, credentialing, or certification requirement limiting the scope of activities of persons acting without such license, credential or certification; and (k) any state or federal laws, rules and regulations governing the use, disclosure, privacy or security of personal health information, including without limitation, the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the implementing regulations and guidance issued thereunder from time to time (collectively, “HIPAA”).
Health Care Regulatory Laws mean (i) 21 U.S.C. §§ 301 et seq. (the Federal Food Drug and Cosmetic Act) and the regulations promulgated thereunder; (ii) Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk (the Medicare statute), and the regulations promulgated thereunder; (iii) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396dd (the Medicaid statute) and the regulations promulgated thereunder; (iv) TRICARE, 10 U.S.C. § 1071 et seq. and the regulations promulgated thereunder, ((ii), (iii) and (iv) each, a “Federal Health Care Program”); (v) the Federal Health Care Program Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. §§ 0000x-0x(x) and the regulations promulgated thereunder; (vi) the False Claims Act, 31 U.S.C. §§ 3729-3733 and the regulations promulgated thereunder; (vii) the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812 and the regulations promulgated thereunder; (viii) the Anti-Kickback Act of 1986, 41 U.S.C. §§ 51-58 and the regulations promulgated thereunder; (ix) the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b and the regulations promulgated thereunder; (x) the Exclusion Laws, 42 U.S.C. § 1320a-7 and the regulations promulgated thereunder; (xi) the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191 and the regulations promulgated thereunder; (xii) any foreign, federal, state and local privacy statutes, regulations and orders; (xiii) Title 45 part 46 of the Code of Federal Regulations (the regulations promulgated by the Health and Human Services Office of Human Rights Protection); (xiv) the Belmont Code; (xv) the Declaration of Helsinki; (xvi) the International Conference on Harmonization (ICH) Consolidated Guidance on Good Clinical Practice E6 and Good Distributions Practices, including any ICH clinical risk management and general principles; (xvii) the Protection of Human Subjects and Financial Disclosure requirements of 21 CFR Parts 50 and 54; (xviii) the Electronic Records; Electronic Signatures requirements of 21 CFR Part 11; (xix) the Federal Controlled Substances Act, 21 U.S.C. § 801 et seq. and the regulations promulgated thereunder; (xx) the foreign, state and local equivalents of such Laws in jurisdictions where it does business; and each of (i) through (xx) as amended from time to time.