Laws & regulations

Article • Dutch healthcare

Divisions need revisions

Dutch healthcare is internationally viewed as high level. However, the cost of care continues to rise, despite all the cuts.

Article • No standardisation

Lab medicine in Norway, Serbia and France

Laboratory medicine delivery, regulation and accreditation vary between countries, e.g. Norway, Serbia and France recently aired at FiLM 2017. Leading figures explained the shape, scope and funding of healthcare and lab services and roles played by different professionals and challenges they face.

News • European Commission

Proposal on endocrine-disrupting chemicals fails to protect public

The Endocrine Society expressed disappointment in the European Commission's revised proposal on defining and identifying endocrine-disrupting chemicals (EDCs), citing unnecessarily narrow criteria for identifying EDCs that will make it nearly impossible for scientists to meet the unrealistically high burden of proof and protect the public from dangerous chemicals.

Article • Legislation

IVDs under the microscope

European regulators have turned the world of in vitro diagnostics (IVDs) upside down with new legislation that will come into effect at the end of this year. The new EU legislation gives manufacturers five years to meet strict standards. That may not be enough time.

News • Politics

New EU recommendations on Cytotoxic Drugs

New policy recommendations on preventing occupational exposure to cytotoxic drugs were launched in the European Parliament on 26 April 2016, an important new initiative designed to protect healthcare professionals working across the EU.

News • Contrast agents

MultiHance receives approval for use in MRI of the whole body

Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, today announced the approval of the use of MultiHance® (gadobenate dimeglumine) in Magnetic Resonance Imaging (MRI) of the whole body in adults and paediatric patients (> 2 years). The approval was obtained through a Mutual Recognition Procedure, with the Medicines and Healthcare products Regulatory Agency…

News • Infection

Siemens Zika test receives FDA emergency use authorization

The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical…

Medical device regulation in the EU and US needs urgent reform

Patients and clinicians need greater regulatory transparency to make informed decisions about treatment Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ.

News • Fraud

Fighting against counterfeit medicine

Around the world, especially in developing nations, counterfeit medicines are a real problem. Until now, in many countries there hasn't been a standard protocol to conduct investigations and pursue prosecution. New research, led by Michigan State University, is providing the foundation to apply criminology theory to preventing the production and sale of fake and substandard medicines.

News • Data Protection Regulation

COCIR urges harmonised enforcement of the DPR

COCIR welcomes the adoption of the European Data Protection Regulation (DPR). However, in order for the Regulation to deliver on its objectives, it is crucial that EU Member States move rapidly towards a harmonised interpretation and enforcement of its provisions. This will pave the way for growth, innovation and a data-driven healthcare sector.

News • Science

How the brain decides blame and punishment

Juries in criminal cases typically decide if someone is guilty, then a judge determines a suitable level of punishment. New research confirms that these two separate assessments of guilt and punishment – though related - are calculated in different parts of the brain. In fact, researchers found that they can disrupt and change one decision without affecting the other.

News • Quality Results

Need for patient-friendly reports in direct-to-consumer testing

Noting a paradigm shift among consumers who are seeking greater control over their own healthcare, AACC issued a position statement today on direct-to-consumer laboratory testing, which allows people to order medical tests directly from a lab without having to work with their healthcare provider. The statement emphasizes direct-to-consumer test results must be accurate and easily understood—an…

Article • IVD regulations

'We will need a lot more regulators'

The proposed EU draft IVD regulation looks set to have major implications for IVD manufacturers and laboratory-developed tests (LDTs). Replacing a current system that is inflexible, unresponsive and does not effectively protect patients, the new regulation will apply directly to all 28 EU countries and govern the manufacture and marketing of in vitro diagnostic devices (IVDs).

News • New guidance

Contact precautions for hospital visitors

Leading infectious diseases experts have released new guidance for healthcare facilities looking to establish precautions for visitors of patients with infectious diseases. The guidance looks to reduce the potential for healthcare visitors in spreading dangerous bacteria within the healthcare facility and community. The recommendations are published online in Infection Control & Hospital…

Article • Treating Ebola

An isolation unit flying on 60-metre wings

The ‘Robert Koch’ plane for medical evacuations (MedEvac) is the winged equivalent of a German hospital isolation ward. Within it, medics with viral haemorrhagic fever while working on the Ebola outbreak in West Africa, receive intensive medical care during any stages of the disease, while being evacuated. Report: Anja Behringer

Article • Population Imaging

Ethical considerations arise from incidental findings

ECR 2015 evoked Shakespeare´s repertoire as delegates were asked to ponder the ethical implications of incidental findings in large population imaging studies in Vienna. Report: Mélisande Rouger

Article • Harmonising Imaging

Could the dream ever come true?

Every European knows how differences can boost cultural diversity and open unexpected perspectives – but, when it comes to having a homogeneous standard of care, they can become an absolute nightmare.

Interview • Structured reporting

Liberating radiologists to be expert consultants

Where some decry the commoditisation of radiology, Gabriel Krestin MD, sees an opportunity to redefine the profession, for radiologists to rise up from basement reading rooms to consult as equals with other medical specialists in multi-disciplinary conferences focused on patient care. ‘If we are going to think about the future, we should not be looking in a rear view mirror. We need to be open…

News • Research

Obesity is Not a Disability

Sermo, the social network for doctors, announced the results of a poll of 2,238 doctors on the contentious issue of whether obese individuals should be considered disabled. An overwhelming majority of doctors, 88 percent, disagreed with a new ruling from the European Union under which employers will be required to protect obese workers and provide them with special parking spaces, larger seats…

Interview • Diagnostics

Reimbursement rates must be negotiated

Last October the Association of the German Diagnostics Industry (VDGH) warned that the proposed EU regulation on in vitro diagnostic medical devices will increase production costs. Simultaneously with the Brussels proposal publication, the German Federal Ministry of Health presented a draft fees regulation that includes significant increases and several new fees, inter alia the minimum fee for…