Digital health and artificial intelligence sit at the intersection of several regulatory regimes. Software that has a medical purpose is regulated as a medical device under the MDR or IVDR, many AI-enabled devices are also high-risk systems under the EU AI Act, and reimbursement pathways such as Germany's DiGA add further requirements. This page collects the updates HealthSignal tracks on the AI Act, Software as a Medical Device, clinical decision support, cybersecurity, and digital health reimbursement, drawn only from official public sources.
Informuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTNewΑρ. πρωτ. 92834 Ανάκληση της παρτίδας 202412 του Καλλυντικού προϊόντος ALOHA Nails & Cosmetics REPAIR GEL MILKY LILAC, λόγω παρουσίας
Greece EOFInformuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTData : 13/07/2026
Portugal INFARMEDData : 18/07/2026
Portugal INFARMEDAz NNGYK indikáción túli gyógyszerrendelési ajánlásai link: tranexamic acid hatóanyagú gyógyszerek lokális és intraarticularis alkalmazásának intézményi szintű engedélyezése vérzéscsökkentés céljából or
Hungary NNGYKWest Nil Virus (WNV) – Frankreich Neu Sicherheitsinformation | Blut & Gewebe | 17.07.2026 Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der französischen Behörde mitgete...
Austria BASG12.06.2026. Zāļu valsts aģentūrā saskaņota reģistrācijas īpašnieka Roche Registration GmbH (Vācija) vēstule veselības aprūpes speciālistam “Evrysdi ( risdiplamum ) 0,75 mg/ml pulveris iekšķīgi lietojama šķīduma pagata...
Latvia ZVA (State Agency of Medicines)10.07.2026. 2026. gada 15. jūlijā tiks atvērta pieteikšanās brīvajiem laikiem zāļu reģistrācijas pieteikumu izskatīšanai 2027. gadam DCP procedūrām (Latvija kā atsauces valsts (RMS)) un nacionālajām reģistrācijas proc...
Latvia ZVA (State Agency of Medicines)AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)News announcement 16 July 2026 General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier 1 min read
EC Public HealthFact Sheets Jul 16, 2026 Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fa...
US CMS NewsroomZainteresirano javnost obveščamo, da je Ministrstvo za zdravje (v nadaljevanju: MZ) na podlagi četrtega odstavka 180. člena Zakona o zdravilih (Uradni list RS, št. 17/14, 66/19, 102/24 – ZZKZ, 24/25, […]
Slovenia JAZMPPeople in England with a type of chronic heart failure could benefit from a new treatment option. Our final draft guidance recommends finerenone for adults with chronic heart failure with preserved or mildly reduced e...
UK NICEThis proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative ...
US Federal Register - CMS Rules16-07-2026 - Dentistes : Interdiction de facturer des suppléments en ambulatoire aux bénéficiaires de l’intervention majorée Depuis le 1er juillet 2026, l’interdiction de facturer des suppléments aux bénéficiaires de ...
INAMI-RIZIV (Belgian HTA)Informuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTActualité
ANS - French Digital Health AgencyCases of iatrogenic botulism have been reported following the therapeutic or cosmetic use of botulinum toxin containing products where the toxin’s effect extends beyond the area of treatment. Patients should seek imme...
UK MHRAPress Releases Jul 14, 2026 CMS Proposes Transformational Medicare Reforms to Expand Accountable Care, Modernize Physician Payment, and Shift from Sick Care to Healthcare CMS Proposes Transformational Medicare Reforms...
US CMS NewsroomInformuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommenda...
US Federal Register - FDA Guidance NoticesGenerar PDF Fecha de publicación: 14 de julio de 2026 Categoría: medicamentos de uso humano Referencia: MUH, 08/2026 La medida se ajusta a la normativa y a las guías europeas aplicables a las variaciones de tipo IA/IA...
AEMPS (Spanish Medicine Agency)The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and...
US Federal Register - FDA Rules13.07.2026. Jauna drošuma informāciju par desogestrelu un etonogestrelu saturošiem kontracepcijas līdzekļiem, kā arī par Litfulo – zālēm perēkļveida matu izkrišanas ārstēšanai Desogestrelu un etonogestrelu saturošas z...
Latvia ZVA (State Agency of Medicines)News announcement 8 July 2026 Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026) 1 min read
European Health Data SpaceA procedure that keeps donor livers supplied with oxygen inside the body before removal has been recommended for NHS use and could help more people on the transplant waiting list.
UK NICEThis proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experi...
US Federal Register - CMS RulesPRESS RELEASE | 07 July 2026 Commission presents EU Action Plan on Cybersecurity and Artificial Intelligence
EU AI Act ImplementationThe AI Act is the first-ever legal framework on AI, which addresses the risks of AI and positions Europe to play a leading role globally.
EU AI Act ImplementationThis guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.
UK MHRAThis guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.
UK MHRAPeople with polyendocrine metabolic ovarian syndrome (PMOS) should have their condition diagnosed sooner and be offered an annual review to monitor symptoms, treatment and long-term health risks, according to our draf...
UK NICERelonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
UK MHRAThis register contains all websites that are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell medicines online, in Northern Ireland.
UK MHRAThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #109 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #110 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Porcines." This guidan...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #90 entitled "Effectiveness of Anthelmintics: General Recommendations." This guidance has been dev...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #111 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Canines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #97 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Caprines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #96 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Ovines." This guidance ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #113 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Felines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #95 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines." This guidance...
US Federal Register - FDA Guidance Notices