Technology for Economic and Clinical Health Act (HITECH Act) (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof. Since January 1, 2019, neither the Company nor its subsidiaries has received written 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 Companys knowledge, no such
claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees,
settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, since January 1, 2019, none of the Company, its subsidiaries or its respective directors, officers, employees, or, to the
knowledge of the Company, contractors or agents, has been, or is currently, 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. Since January 1, 2019, the Company and its subsidiaries have filed, obtained,
maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission).
(rr) The Company and each of its subsidiaries are, and at all prior times since January 1, 2019 were, in material
compliance with all applicable data privacy and security laws, rules, and regulations regarding the collection, use, transfer, storage, protection, disposal or disclosure of sensitive information (including Personal Data (as defined below))
generated by Company or collected from or provided by third parties, including, without limitation, the European Union General Data Protection Regulation (GDPR) (EU 2016/679) (collectively, the Privacy Laws).
Personal Data means (i) any information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked with a particular individual, including the following information
if it identifies, relates to, describes, is reasonably capable of being associated with, or could be reasonably linked, directly or indirectly, with a particular individual: a natural persons name, street address, telephone number, e-mail address, photograph, social security number or tax identification number, drivers license number, passport number, credit card number, bank information, or customer or account number; (ii)
personal data as defined by GDPR (to the extent the GDPR applies), and (iii) other information that identifies such natural person, or his or her family, except any protected health information as defined by HIPAA. To
the extent required by Privacy Laws, the Company and its subsidiaries have in place, materially comply with, and take appropriate steps to ensure
16