Who was sanctioned, and for what?

The medical technology manufacturer misled investors about regulatory risks of the Alaris infusion pump, which had more than 25 software defects, and did not record the remediation costs, as a result of which operating income in the fourth quarter of 2019 was overstated by 82 %. BD is paying 175 million USD and must appoint an independent compliance consultant.

Authority / court

U.S. Securities and Exchange Commission (SEC)

Area of law

Capital markets and financial supervision · Disclosure and reporting obligations

Legal basis

Antifraud-, Reporting-, Buchführungs-, interne Kontroll- und Disclosure-Controls-Vorschriften der US-Wertpapiergesetze

Action

Fine

Status of proceedings

final

Sector

Healthcare

Original amount 175,000,000 USD, converted at the ECB reference rate of 16 Dec 2024.

Checked against the official source on 28 Sep 2026 · Version 2 · Direct link

Hospital staff opened a colleague's electronic health record to organise duty rosters during Covid rather than for treatment purposes. Technical barriers limiting access to treating staff were lacking; the Italian data protection authority (Garante per la protezione dei dati personali) imposed 24,000 EUR (Provvedimento No. 616).

Authority / court

Garante per la protezione dei dati personali

Area of law

Data protection · Employee data

Legal basis

Art. 5 Abs. 1 lit. a, b, c, f, Art. 9, 25, 32 DSGVO; Art. 75 Codice privacy; Linee guida dossier sanitario

Action

Fine

Status of proceedings

unknown

Sector

Healthcare

Published

11 Sep 2026

Checked against the official source on 25 Sep 2026 · Direct link

The neurotechnology company from Dallas, described by the Bureau of Industry and Security (BIS, the export control agency of the US Department of Commerce) as small, delivered neural data acquisition systems (“OmniPlex”) and accessories worth around 179,000 USD on eight occasions in 2022/23 via its Asian distributor to the Chinese Academy of Military Medical Sciences, which has been on the Entity List (the US export control list of restricted parties) since December 2021. The penalty of 1.7 million USD is suspended for five years and then waived, provided that Plexon submits an external audit of its export compliance programme on time and commits no further violations; a five-year denial of export privileges is likewise suspended, and Plexon must also provide export control training.

Authority / court

U.S. Department of Commerce, Bureau of Industry and Security (BIS)

Area of law

Sanctions and export control · Export control and dual-use goods

Legal basis

Export Administration Regulations, 15 C.F.R. § 764.2(a), § 744.11

Action

Fine

Status of proceedings

final

Sector

Healthcare

Mitigating circumstances

Penalty and denial of export privileges fully suspended for five years, conditional on an external export control audit.

Published

14 Aug 2026

Original amount 1,700,000 USD, converted at the ECB reference rate of 14 Aug 2026.

Checked against the official source on 28 Sep 2026 · Direct link

The Houston laboratory allegedly paid kickbacks and billed Medicare and Medicaid for medically unnecessary genetic tests. The settlements with the laboratory and other parties add up to 36.4 million USD (combined total); the laboratory is subject to a Corporate Integrity Agreement.

Authority / court

U.S. Department of Justice

Area of law

Bribery and corruption · Commercial bribery

Legal basis

Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); False Claims Act (31 U.S.C. §§ 3729 ff.)

Action

Other

Status of proceedings

final

Sector

Healthcare

Liability of senior managers

Measures against individuals are not reported here.

Original amount 36,400,000 USD, converted at the ECB reference rate of 30 Jul 2026.

Checked against the official source on 28 Sep 2026 · Version 3 · Direct link

In summer 2025, an attacker gained access to the private hospital's electronic patient record system and obtained data on 524,867 patients and 202,246 trusted persons. There was no VPN or multi-factor authentication for external users, no appropriate access control and no detection of suspicious activity; the trusted persons were not notified. France's data protection authority (Commission nationale de l'informatique et des libertés, CNIL) imposed a fine of 500,000 EUR (SAN-2026-009).

Authority / court

Commission nationale de l'informatique et des libertés (CNIL)

Area of law

Data protection · Data breaches and data security

Legal basis

DSGVO Art. 32, Art. 34

Action

Fine

Status of proceedings

final

Sector

Healthcare

Published

3 Sep 2026

Checked against the official source on 25 Sep 2026 · Direct link

The Florida laboratory provided referring physicians with consulting services below market value and paid independent consultants referral-based remuneration for recruiting physicians. Following a self-disclosure, NeoGenomics paid 9,813,260 USD.

Authority / court

U.S. Department of Justice

Area of law

Bribery and corruption · Commercial bribery

Legal basis

Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); False Claims Act (31 U.S.C. §§ 3729 ff.)

Action

Other

Status of proceedings

final

Sector

Healthcare

Mitigating circumstances

Self-disclosure of the remuneration arrangements.

Original amount 9,813,260 USD, converted at the ECB reference rate of 20 Jul 2026.

Checked against the official source on 25 Sep 2026 · Direct link

From May to the end of August 2024, the public hospital accidentally published on its website a surgery list containing patients' telephone numbers, illnesses and planned procedures; a member of the public found the document via Google. The Hellenic Data Protection Authority imposed a total of 25,000 EUR: 10,000 EUR for inadequate security, 2,000 EUR for the late notification, 10,000 EUR for failing to notify the data subjects and 3,000 EUR for missing contact details of the data protection officer (DPO).

Authority / court

Αρχή Προστασίας Δεδομένων Προσωπικού Χαρακτήρα (Hellenic Data Protection Authority)

Area of law

Data protection · Data breaches and data security

Legal basis

DSGVO Art. 5 Abs. 1 lit. f, 32 Abs. 1, 33 Abs. 1, 34 Abs. 1, 12, 13 i. V. m. 37 (Entscheidung 13/2026)

Action

Fine

Status of proceedings

final

Sector

Healthcare

Checked against the official source on 25 Sep 2026 · Direct link

On application by a competitor, the Комисия за защита на конкуренцията (Bulgarian Commission for the Protection of Competition, KZK) established that the laboratory had offered packages of medical laboratory tests free of charge nationwide over extended periods (only against a fee of 2 leva for taking blood) – conduct shown by no other market participant outside joint campaigns. It found an infringement of the general clause of unfair competition law (Art. 29 ZZK – Bulgarian Protection of Competition Act) and imposed 0.3% of 2024 turnover, i.e. 52,096.55 EUR. Appeals have been lodged against the decision.

Authority / court

Комисия за защита на конкуренцията (КЗК, Bulgarische Wettbewerbskommission)

Area of law

Competition law

Legal basis

Art. 29 ZZK (Generalklausel unlauterer Wettbewerb)

Action

Fine

Status of proceedings

under appeal

Sector

Healthcare

Published

2 Jul 2026

Checked against the official source on 28 Sep 2026 · Version 2 · Direct link

In the teaching hospital's virology laboratory, the lid of a centrifuge fell on an employee who had to hold it open by hand because of a defective gas spring; she was seriously injured. Maintenance reports from 2023 and 2024 had already called for the spring to be replaced. Fine of CA$65,000 plus victim fine surcharge.

Authority / court

Provincial Offences Court Hamilton (Ermittlung: Ontario Ministry of Labour, Immigration, Training and Skills Development)

Area of law

Health and safety and employment law · Workplace safety and accidents

Legal basis

Section 25(1)(b) Occupational Health and Safety Act (Ontario)

Action

Fine

Status of proceedings

final

Sector

Healthcare

Mitigating circumstances

Guilty plea; repair two days after the accident.

Published

21 Jul 2026

Original amount 65,000 CAD, converted at the ECB reference rate of 18 Jun 2026.

Checked against the official source on 25 Sep 2026 · Direct link

The Arkansas pathology laboratory and its management company allegedly granted unlawful kickbacks and ordered medically unnecessary tests. The settlement of 30 million USD is a joint payment by all settling parties; the laboratory entered into a Corporate Integrity Agreement.

Authority / court

U.S. Department of Justice

Area of law

Bribery and corruption · Commercial bribery

Legal basis

Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); False Claims Act (31 U.S.C. §§ 3729 ff.)

Action

Other

Status of proceedings

final

Sector

Healthcare

Liability of senior managers

Measures against individuals are not reported here.

Original amount 30,000,000 USD, converted at the ECB reference rate of 17 Jun 2026.

Checked against the official source on 28 Sep 2026 · Version 3 · Direct link

Monash IVF collected sensitive information about visitors to its fertility treatment website through third-party tracking pixels. The Privacy Commissioner held that following the visitors of health-related websites and afterwards showing them targeted adverts on social networks amounts to collecting sensitive data, which requires consent, and found breaches of APP 3.3, 5.1, 5.2 and 7.1. Monash IVF must not continue or repeat the conduct and must implement specified remedial steps; a parallel determination against the telehealth provider Medmate Australia was made on the same day.

Authority / court

Office of the Australian Information Commissioner (OAIC)

Area of law

Data protection · Cookies and tracking

Legal basis

Privacy Act 1988 (Cth), APP 3.3, 5.1, 5.2, 7.1

Action

Order

Status of proceedings

unknown

Sector

Healthcare

Published

24 Jun 2026

Checked against the official source on 3 Oct 2026 · Direct link

In November 2018 attackers encrypted patient data in the laboratory information system of Midlands Regional Hospital Tullamore. The DPC found that the HSE had infringed Art. 5(1)(f), 28, 30, 32(1) and 34 GDPR (including insufficient security, deficient processor contracts and record of processing, and incomplete notification of affected persons), issued a reprimand, imposed €300,000 for the security failings (Art. 5(1)(f) and 32(1)) and ordered it to introduce specified policies and procedures for secure processing.

Authority / court

Data Protection Commission (DPC)

Area of law

Data protection · Data breaches and data security

Legal basis

Art. 5(1)(f), 28, 30, 32(1), 34 DSGVO

Action

Fine

Status of proceedings

unknown

Sector

Healthcare

Checked against the official source on 2 Oct 2026 · Direct link

The non-profit hospital group Ascension wanted to acquire AmSurg for 3.9 billion USD. Owing to overlaps in outpatient surgery in five regions, the Federal Trade Commission (FTC) requires the sale of seven AmSurg centres to SC Affiliates and a gastroenterology practice, as well as transitional support.

Authority / court

Federal Trade Commission (FTC)

Area of law

Competition law · Merger control

Legal basis

Section 7 Clayton Act; Section 5 FTC Act (Consent Order)

Action

Order

Status of proceedings

unknown

Sector

Healthcare

Employees

10,000 or more

Checked against the official source on 25 Sep 2026 · Direct link

The CNIL (French data protection authority) fined IQVIA Operations France EUR 5,000,000 because, for two health data warehouses authorised by the CNIL (fed with data from around 14,000 pharmacies and several thousand medical practices), the company did not comply with the conditions of the authorisations, including log analysis, multi-factor authentication, patient information and the right to object. In addition, pharmacy customers were not informed of the transfer of their data, in-house studies were carried out without the required authorisation and the pharmacy software transmitted data even after a refusal (Art. 25 GDPR). The CNIL classified the data as pseudonymised rather than anonymous and ordered remedial action within six months, subject to a penalty payment of EUR 10,000 per day.

Authority / court

Commission nationale de l'informatique et des libertés (CNIL), formation restreinte

Area of law

Data protection · Data subject rights and transparency

Legal basis

Art. 66 Loi n° 78-17 du 6 janvier 1978 (Loi Informatique et Libertés); Art. 14 und 25 DSGVO

Action

Fine

Status of proceedings

unknown

Sector

Healthcare

Culpability

negligent

Mitigating circumstances

The security shortcomings were remedied after the inspections.

Published

28 May 2026

Checked against the official source on 2 Oct 2026 · Direct link

The Californian provider of mobile PET scans allegedly paid referring cardiologists excessive fees for supervising the examinations in order to secure referrals. The settlement of 8,334,350.71 USD plus revenue-based payments is based on ability to pay; in addition, there is a Corporate Integrity Agreement.

Authority / court

U.S. Department of Justice / U.S. Attorney's Office, Central District of California

Area of law

Bribery and corruption · Commercial bribery

Legal basis

Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); False Claims Act (31 U.S.C. §§ 3729 ff.)

Action

Other

Status of proceedings

final

Sector

Healthcare

Original amount 8,334,350.71 USD, converted at the ECB reference rate of 30 Apr 2026.

Checked against the official source on 25 Sep 2026 · Direct link

Following an investigation by SafeWork NSW, the District Court of NSW fined LiveBetter Services Limited 675,000 AUD for a breach of ss 32/19(2) of the Work Health and Safety Act 2011. In February 2022, a participant in the National Disability Insurance Scheme (NDIS) was placed in a bath with excessively hot water, suffered serious burns and died from her injuries.

Authority / court

SafeWork NSW

Area of law

Health and safety and employment law · Workplace safety and accidents

Legal basis

Work Health and Safety Act 2011 (NSW) ss 32/19(2)

Action

Fine

Status of proceedings

unknown

Sector

Healthcare

Original amount 675,000 AUD, converted at the ECB reference rate of 30 Apr 2026.

Checked against the official source on 3 Oct 2026 · Direct link

Four laboratories and their association coordinated negotiations on prices with health insurers, coordinated in tenders, exchanged sensitive information and allocated customers. At first instance, the Protimonopolný úrad Slovenskej republiky (Antimonopoly Office of the Slovak Republic, PMÚ SR) imposed 14,551,800 EUR and three-year procurement bans; Unilabs received a substantially reduced fine as leniency applicant and under a settlement.

Authority / court

Protimonopolný úrad Slovenskej republiky (PMÚ SR)

Area of law

Competition law · Cartels and collusion

Legal basis

Slowakisches Wettbewerbsschutzgesetz (Kartellverbot)

Action

Fine

Status of proceedings

unknown

Sector

Healthcare

Culpability

intentional

Mitigating circumstances

Unilabs: leniency reduction (50%) and settlement (a further 30%).

Published

12 May 2026

Checked against the official source on 25 Sep 2026 · Direct link

The starting point was a complaint about incomplete disclosure of patient data; the clinic left several requests from the supervisory authority unanswered. The Andmekaitse Inspektsioon (Estonian Data Protection Inspectorate, AKI) ordered it to revise its contracts with Align Technology (Invisalign) with regard to the GDPR roles (Art. 26/28 GDPR), to adapt the consent form and the privacy notices in accordance with Art. 7, 9, 13 and 14 GDPR and to publish them in Estonian; non-compliance is subject to a penalty payment of 1,000 EUR per item.

Authority / court

Andmekaitse Inspektsioon (AKI)

Area of law

Data protection · Data processors

Legal basis

§ 56 Abs. 1 IKS; Art. 58 Abs. 2 lit. d DSGVO i. V. m. Art. 5 Abs. 1 lit. a, 7, 9, 13, 14, 26, 28 DSGVO

Action

Order

Status of proceedings

unknown

Sector

Healthcare

Checked against the official source on 28 Sep 2026 · Version 2 · Direct link

A general practitioner who had no longer been treating the complainant since January 2023 accessed his health data (findings, prescriptions) on the national e-health platform EESZT a total of 47 times via his practice software until August 2024 and did not respond to an access request. The Hungarian data protection authority (Nemzeti Adatvédelmi és Információszabadság Hatóság, NAIH) found infringements of Art. 5(2), 6(1), 9(2), 12(2) and 15(1) GDPR, ordered compliance with the access request and imposed 500,000 HUF.

Authority / court

Nemzeti Adatvédelmi és Információszabadság Hatóság (NAIH)

Area of law

Data protection · Data subject rights and transparency

Legal basis

DSGVO Art. 5 Abs. 2, 6 Abs. 1, 9 Abs. 2, 12 Abs. 2, 15 Abs. 1

Action

Fine

Status of proceedings

final

Sector

Healthcare

Published

20 Mar 2026

Original amount 500,000 HUF, converted at the ECB reference rate of 20 Mar 2026.

Checked against the official source on 28 Sep 2026 · Version 2 · Direct link

In parallel with the US declination, the PNF concluded a CJIP with the US subsidiary of the French medical technology manufacturer for 1,765,493 EUR (after crediting the US disgorgement) and a three-year AFA compliance programme. The case arose from Balt SAS's voluntary self-disclosure of 22 May 2023 concerning conduct at the acquired company Blockade Medical.

Authority / court

Parquet national financier (PNF); Validierung durch den Präsidenten des Tribunal judiciaire de Paris

Area of law

Bribery and corruption · Bribery of public officials

Legal basis

Art. 41-1-2 Code de procédure pénale (CJIP); aktive und passive Bestechung von Amtsträgern

Action

Fine

Status of proceedings

final

Sector

Healthcare

Employees

250 to 999

Culpability

intentional

Mitigating circumstances

Voluntary self-disclosure to the PNF and the DOJ; coordinated resolution with crediting.

Liability of senior managers

The CJIP does not address the criminal liability of natural persons.

Published

19 Mar 2026

Checked against the official source on 28 Sep 2026 · Version 2 · Direct link