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Healthcare

The healthcare sector is highly regulated with healthcare standards, rules and legislation. To help manufacturers sift through the minefield of regulations, we bring together industry and Government stakeholders to produce healthcare standards that ensure the safe provision of healthcare throughout the UK and to support emerging industries such as eHealth and nanotechnology.

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BS ISO 7101: A blueprint for quality management in healthcare
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BS ISO 7101: A blueprint for quality management in healthcare

In an era where healthcare systems worldwide are facing a host of complex challenges, the introduction of BS ISO 7101 - the first international consensus standard for healthcare quality management – provides an opportunity for actionable transformation. From diminishing financial resources and shortages in the workforce to escalating rates of chronic diseases and insufficient data for informed decision-making, healthcare organizations globally have encountered substantial challenges over recent years. Serving as the first international standard for healthcare quality management, BS ISO 7101:2023 Healthcare organization management. Management systems for quality in healthcare organizations. Requirements addresses these challenges head-on. This document provides a universal set of requirements applicable to any healthcare system, organization, or entity seeking to elevate the quality of its healthcare services. What is BS ISO 7101? BS ISO 7101 establishes a roadmap for healthcare organizations to adopt a systematic approach towards sustainable, high-quality health systems. It outlines a comprehensive framework to enhance the quality of healthcare delivery and care outcomes. The standard includes a set of essential requirements designed to guide organizations of varying scales, structures, and regions. These include: the creation of a culture of quality, embracing people-centered care, risk identification and management, ensuring patient and workforce safety, controlling service delivery through documented processes, and continual monitoring and improvement of performance. Want to learn more about how standards are supporting the healthcare sector? Discover our Healthcare industry page. Why should your healthcare organization use BS ISO 7101? Implementing BS ISO 7101 is a strategic move for healthcare organizations. The standard encourages evidence-based methods, transparency, and a culture that prioritizes quality. While it necessitates some documentation, its primary objective is to establish transparent processes without burdening organizations with excessive administrative tasks. BS ISO 7101 provides flexibility, making it applicable to diverse healthcare providers, from small clinics to large hospitals. Conformity can be demonstrated through various means, including self-declaration, seeking confirmation from interested parties, or obtaining certification from an external organization. Successful implementation signals to stakeholders that an effective healthcare quality management system is in place. What are the benefits of using BS ISO 7101? BS ISO 7101 is not just a set of requirements, it is a tool for navigating the complexities of modern healthcare. As the world experiences a surge in virtual healthcare and technological advances, the standard emphasizes the importance of timely, safe, and people-centered care. The benefits its application can bring include: Improved quality of healthcare delivery. Improved patient safety. Increased planning for sustainable healthcare service delivery. Enhanced operational effectiveness and cost-efficiency. A strengthened reputation with an extended market reach. These outcomes not only contribute to the well-being of patients, but also can position your healthcare organization as a reliable and high-quality service provider in a competitive market. It equips your business to adapt to these changes, ensuring that you continue to provide high-quality care, even in the face of global pandemics and evolving healthcare landscapes. Ensure your healthcare business is reaping the benefits of managing quality effectively. Download BS ISO 7101 today.Read more
BS EN 14683:2025: The updated medical face mask standard explained
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BS EN 14683:2025: The updated medical face mask standard explained

Medical face masks are a critical component of infection prevention in healthcare settings. They help to limit the transmission of infectious agents from healthcare staff to patients, playing a key role in surgical and clinical environments. To ensure they meet the highest performance, safety, and regulatory standards, BS EN 14683:2025 Medical face masks - Requirements and test methods has been revised to reflect the latest international knowledge, technological advancements, and regulatory requirements. This revision not only strengthens testing and performance requirements but also incorporates new considerations for transparent masks, sustainability, and manufacturing processes. These updates align with Medical Device Regulation (EU) 2017/745, ensuring compliance across European markets. For manufacturers, healthcare institutions, procurement professionals, and testing laboratories, understanding these updates and adapting accordingly is essential to ensure compliance and maintain market competitiveness. What is BS EN 14683 and why is it important? BS EN 14683 is a European standard that specifies the design, construction, performance, and testing requirements for medical face masks used in surgical and clinical settings. These masks act as a barrier against infectious agents, protecting both patients and healthcare workers. For users of the standard, it provides clear guidelines and performance benchmarks to ensure medical face masks are safe, effective, and compliant with regulatory requirements.  It helps manufacturers design and test products, procurement teams assess quality for contracts and tenders, and healthcare providers select masks that meet infection control standards. By standardizing key requirements like bacterial filtration, breathability, and microbial cleanliness, BS EN 14683 ensures consistency and reliability across the industry. Discover how standards support safety, quality and effective equipment and service provision throughout the healthcare sector by visiting our Healthcare topic page. What are the changes to BS EN 14683? BS EN 14683:2025 is the latest edition of the standard. It has been revised to ensure clarity, performance enhancement, and broader market acceptance. One of the most notable future changes outlined in Annex E is the proposed removal of Type I medical face masks in the next revision. Healthcare organizations and manufacturers should begin evaluating their current mask offerings to prepare for this transition. Additionally, as reusable masks gain more attention, this standard provides a framework for future sustainable innovations in medical face protection. Other significant updates include: 1. Improved testing and performance criteria for medical face masks Microbial cleanliness test completely revised to provide more detailed and reliable results. Refined bacterial filtration efficiency (BFE) test methodology for greater accuracy. Updated breathability test now includes a formula for airflow calculation. 2. Enhanced inclusion and accessibility for medical face masks New requirements for transparent medical face masks to improve communication for deaf and elderly patients. Clearer design guidelines to ensure masks meet both functional and accessibility needs. 3. Stronger manufacturing and documentation processes for medical face masks New clause on manufacturing and processing requirements to improve quality control. Updated documentation requirements to ensure traceability and regulatory compliance. 4. Greater focus on the sustainability of medical face masks New annex on environmental impact, supporting eco-friendly manufacturing practices. Formal recognition of reusable medical face masks, promoting circular economy initiatives. 5. Regulatory alignment and market access Now aligned with Medical Device Regulation (EU) 2017/745, ensuring market compliance. Updated Annex ZA for harmonization, making it easier for manufacturers to demonstrate conformity. The changes introduced in BS EN 14683:2025 mark a significant step toward greater safety, accessibility, and sustainability in medical face masks. Those affected by these updates should act now to align with the new requirements, ensuring continued compliance, market access, and commitment to high-quality healthcare solutions. Stay compliant and ensure the highest standards of safety, quality, and sustainability in medical face masks. Get your copy of BS EN 14683:2025 today and stay ahead of regulatory changes.
How to manage cybersecurity in the healthcare sector
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How to manage cybersecurity in the healthcare sector

With significant data breaches hitting the headlines each year, healthcare cybersecurity is a major and expanding area for investment and concern. Cybersecurity, according to the UK’s National Cyber Security Centre (NCSC), is ‘how individuals and organizations reduce the risk of cyberattack.’ Cybersecurity should ‘protect the devices we all use and the services we access from theft and damage’ and ‘prevent unauthorized access to the vast amounts of personal information we store on these devices and online. For healthcare organizations, this means that all data stored digitally – everything from medical records to staff bank account details – is kept secure, so it can only be accessed, used, or changed by those authorized to do so. SARS-Cov-2 both raises the possible impact of a cyberattack and increases the likelihood of it happening. With unprecedented demand on healthcare, the impact of service disruption on the scale seen in 2017, could be devastating. Acute services are under strain, and there is no slack in the system to divert patients away from affected hospitals. In addition, while some face-to-face care was possible without access to digital technology in 2017, most of healthcare is now reliant on digital technology. It’s widely accepted that healthcare has lagged behind other industries when it comes to cybersecurity and that the industry needs to close the gap. Healthcare leaders must ensure vital hospital facilities and power supplies can’t fall into the wrong hands – not to mention control of smart medical devices and implants. Thankfully, businesses can use standards to build resilience across diverse cybersecurity fronts simultaneously. The challenge: Making healthcare cybersecure Healthcare managers must protect significant, decentralized, systems containing vital personal data relating to millions of people. Post-GDPR, the consequences of failure are severe. Cybercriminals constantly seek to gain access to this information – especially as many consider healthcare institutions to be soft and slow-moving targets. This data also has significant value on the dark web. There are also many avenues of possible vulnerability – from data breaches, vandalism, and extortion to so-called C-suite attacks, AI-driven malware, and assaults from the computing cloud. What’s more, significant outsourcing, third-party arrangements, and personal device use provide further layers of cybersecurity complication (and potential exploits for criminals). Good cybersecurity combines the right technical barriers with the right culture and staff mindset since most attacks exploit human interaction. Growing Internet of Things (IoT) connectivity presents a further nuance to the cybersecurity challenge. The stakes could scarcely be higher here – directly impacting patient health, safety, or even mortality. Aside from protecting existing structures and safeguarding patients, optimized cybersecurity also helps to remove widespread barriers to innovation in the digital health space. Successfully addressing the challenge truly calls for a combined view of both the micro and macro issues. To learn more about innovation within the healthcare sector, read our article ‘At Home Healthcare: Where is the Consumer Genetic Testing Industry Headed?’. A standard-led approach to cybersecurity In order to develop an effective security-specific strategy, healthcare leaders need to examine their wider organizational standards strategy, across all operational aspects. This can help to ensure a reliable foundation on which to build (for example looking at pillars like BS EN ISO 9001, the internationally recognized quality management standard). With the fundamentals covered, the next task for healthcare leaders could be considering the development of a formalized cybersecurity policy – one which goes far beyond simply backing up data and frequently testing network security to identify potential gaps (although these remain important). Managers can use the global information security standard BS EN ISO/IEC 27001 to create and implement a bespoke management system, and then BS EN ISO/IEC 27002 to develop guidelines that meet international standards. This may also help large healthcare institutions remain agile and responsive in the face of an incident or data breach. Cloud-based services and storage policies will make up a significant portion of any wide-ranging security protocol. BS EN ISO/IEC 27017 provides enhanced controls for providers and customers. It clarifies roles and responsibilities to help make cloud services as secure as any other part of the healthcare IT estate. A robust cybersecurity policy could be considered vital for decentralized systems, with users spread across several geographical locations or campuses. They should detail all security procedures, processes, and responsibilities for staff – both for routine best practices and emergency protocols. It should underline the need for an ‘ever vigilant’ mindset which must be present across every healthcare organization. A vital strand of any BS EN ISO/IEC 27001-based plan is the correct management of patient healthcare data and medical records. BS EN ISO 27701 helps healthcare leaders control this personal information. It outlines how to establish and run a privacy information management system (PIMS). Consideration should also be given in the wider policy to the increasing prevalence of personal device use amongst staff, for routine work and administration. It needs to clarify exactly what’s acceptable, and what responsibilities users have (as well as which applications they can use and where specific risks lie). Building and maintaining resilience to cyberattacks will be always an ongoing, incomplete, process. It’s about building the right culture of awareness and responsibility across all management and staff because healthcare leaders are fighting a constantly evolving threat. A standards-based approach is the most powerful means of organizational defence – optimizing the balance between efficient daily operation and appropriate protection. Protect your healthcare organization from cyberattacks and information theft by adding these key information security standards to your collection today. Discover BSI Knowledge Want to have access to all your cybersecurity standards in one place? A BSI Knowledge subscription gives you instant access to the resources you need to improve your information security processes. The flexibility and visibility it provides of the best practices guidance enables you and your team to get the most from standards - from patient privacy to remote data access. Build your own custom collection of standards, or opt for access to our GBM24 Information Technology - Software & Networking module and keep up-to-date with any relevant changes to your cybersecurity strategy. Request to learn more.
BS 8684: Ensuring safe, effective, and person-centred TEC services
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BS 8684: Ensuring safe, effective, and person-centred TEC services

As more people rely on technology enabled care (TEC) to maintain their independence and well-being, the need for consistent and reliable standards has become increasingly evident. Enter BS 8684:2024, the UK’s first comprehensive standard dedicated to the delivery of TEC services. An estimated 1.8 million people in the UK currently use telecare services. TEC has become a cornerstone of modern care delivery, offering solutions that empower individuals to live independently, safely, and with dignity. From remote monitoring devices to emergency alert systems, it provides invaluable support to millions of people, particularly those who are elderly, disabled, or living with chronic conditions. However, the rapid expansion of TEC has also highlighted significant challenges, including inconsistencies in service delivery, varying levels of safety, and a lack of person-centred approaches. Introducing the first standard for technology enabled care Until now, standardization within the TEC sector has primarily focused on the products themselves—such as devices and alarms—rather than the comprehensive service chain that connects these products to the end users. This gap has led to fragmented service delivery, with inconsistent practices in risk assessments, installation, maintenance, and information sharing. These inconsistencies not only compromise the quality of care but also put vulnerable users at risk. BS 8684:2024 Technology enabled care – Assessment of user needs and risks, system design, installation and maintenance – Code of practice was developed to address these challenges. It provides a much-needed framework that standardizes the design, installation, maintenance, and overall delivery of TEC services. By setting clear guidelines and best practices, this standard aims to ensure that TEC solutions are safe, effective, and truly person-centred. Discover how standards support the provision of healthcare services by visiting our Healthcare Industry page. What is the scope of BS 8684? BS 8684 is a comprehensive standard that covers the entire spectrum of technology enabled care services, focusing on the critical aspects of user assessment, system design, installation, and ongoing maintenance.  The standard is intended for use by a wide range of stakeholders in the care sector, including: Care commissioners: those responsible for procuring and overseeing TEC services. Service providers: organizations delivering TEC services to end users. Housing providers: entities integrating TEC solutions into residential settings.  Installers and maintenance professionals: those responsible for the physical installation and upkeep of TEC devices. Local authorities: government bodies that play a key role in commissioning, regulating, and ensuring the delivery of high-quality TEC services to meet the needs of their communities. The standard outlines recommendations for: Person-centred assessments: ensuring that TEC solutions are tailored to the specific needs and risks of each individual user. Selection and installation of connected products: providing guidelines on choosing the right technology and ensuring it is correctly installed. Maintenance and decommissioning: offering best practices for the ongoing upkeep of TEC devices and their safe removal when no longer needed. Information sharing: emphasizing the importance of clear communication and data sharing among all parties involved in the TEC service chain, including the Alarm Receiving Centre (ARC). Data processing and consent: establishing protocols for the ethical handling of user data, with a focus on privacy and security. What are the benefits of using BS 8684? The primary beneficiaries of BS 8684 are the individuals who rely on technology enabled care to live independently and safely. By adopting this standard, care providers and commissioners can ensure that the TEC services they deliver are not only high-quality but also deeply aligned with the needs and preferences of users. Key benefits include: Enhanced safety and reliability: BS 8684 ensures that all aspects of TEC service delivery are standardized, reducing the risk of errors and inconsistencies that could compromise user safety. From thorough risk assessments to proper installation and maintenance, the standard provides a safety net that protects vulnerable individuals. Person-centred care: one of the core principles of BS 8684 is the emphasis on tailoring TEC services to the unique needs of each user. This person-centred approach ensures that the technology is not only effective but also enhances the individual’s quality of life by supporting their independence and well-being. Improved coordination and communication: the standard promotes better collaboration among all stakeholders involved in the TEC service chain. By ensuring that everyone, from commissioners to service providers to installers, is working from the same playbook, BS 8684 fosters a more cohesive and efficient service delivery model. Greater confidence and trust: For users and their families, knowing that their TEC services are governed by a rigorous standard like BS 8684 provides peace of mind. It reassures them that the technology they depend on is safe, reliable, and fit for purpose. Support for independent living: by ensuring that TEC solutions are appropriately assessed, selected, and maintained, BS 8684 helps users live independently in their own homes for as long as possible, reducing the need for more intensive care interventions. Be at the forefront of technology enabled care solutions. Get your copy of BS 8684:2024 here.

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