Endemik’s Post

📅 Join BioPharmaChem Ireland and Connected Health Skillnet on Friday, 20 September 2024 from 11:00-12:15 for an informative live #webinar on the upcoming NIS 2 Directive where we will be joined by experts Puneet Kukreja and Robert Haniver from EY to explore what it means for the #pharma sector. The NIS 2 Directive aims to achieve a high common level of #cybersecurity across the EU, and will replace its predecessor NIS-D. NIS 2 will impose enhanced cybersecurity obligations on organisations who are subject to NIS-D, and will extend to capture entities in additional sectors and sub-sectors, including manufacturers of certain #pharmaceutical products, medical devices and R&D activities, which were not regulated under NIS-D. With the intended 18 October 2024 deadline for implementation fast approaching, this webinar will give you: ☑ an overview of key aims and requirements of NIS2 ☑ the potential impact it may have on regulated organisations and their supply chains ☑ key #compliance steps organisations should be taking. To book your place please complete the Connected Health Skillnet form here: https://lnkd.in/er85Phxc #biopharma #connectedhealth #webinar #cybersecurity #compliance #supplychains Siobhán Dean Sinead Keogh Karina Cassidy Michael Kilkelly Audrey Devlin Eimear Curran

US pharma giant Cencora says Americans’ health information stolen in data breach 🚨 Important Cybersecurity Update: Cencora Data Breach 🚨 Cencora, a major player in the pharmaceutical services industry, has disclosed a significant data breach that has impacted the sensitive personal information of patients from 11 major pharmaceutical firms. This breach, which occurred in February 2024, has exposed details such as names, addresses, health diagnoses, medications, and prescriptions of affected individuals. This incident highlights the critical importance of robust cybersecurity measures in the healthcare sector. Cencora, formerly known as AmerisourceBergen, reported that while their IT systems remain operational, they are collaborating with law enforcement and cybersecurity experts to fully assess the situation. They have also committed to offering two years of free identity protection and credit monitoring services to those affected. For professionals in the healthcare and cybersecurity fields, this breach underscores the need for continuous vigilance and investment in protecting patient data. Let's stay informed and proactive in safeguarding sensitive information. #Cynergy #Cybersecurity #DataBreach #HealthcareSecurity #Cencora #Pharmaceuticals #PatientPrivacy

➡ As the NIS2 directive looms on the horizon, a critical question emerges: how will it affect the Healthcare & Life Science Sector? The NIS2 (Network and Information Systems) directive represents a significant leap forward in the European Union's efforts to bolster cybersecurity across critical infrastructure sectors, with healthcare and life sciences firmly in its scope. This comprehensive legislation mandates that healthcare providers, pharmaceutical companies, and medical device manufacturers take proactive steps to fortify their digital defences. 🤝 Discover how we can help prepare your healthcare product for new regulations: https://lnkd.in/dHcvDzWS or contact Krzysztof Minicki to discuss your needs. #healthcare #lifescience #NIS2 #cybersecurity #medicalproducts

Thoughts on this? >> The Change Healthcare hack could be a catalyst for real healthcare cybersecurity improvement >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #healthcare #pharmaceutical #productmarketing

📌 Cybersecurity for Medical Devices - FDA considerations 🚀 FDA published a new paper recently : https://lnkd.in/eeEFcyZ5 This draft guidance with topics will be integrated into the premarket cybersecurity document as soon as it is publicly commented on. 👂 One topic in particular will attract the attention of manufacturers: What are "cyber devices"? The current definition is: A “cyber device” is a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device (2) has the ability to connect to the internet and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats. FDA now adds an interpretation: FDA considers devices that include any of the following features to have the ability to connect to the internet. The list below is illustrative, not exhaustive: ◉ Wi-Fi or cellular ◉ Network, server, or Cloud Service Provider connections ◉ Bluetooth or Bluetooth Low Energy ◉ Radiofrequency communications ◉ Inductive communications ◉ Hardware connectors capable of connecting to the internet (e.g., USB, ethernet, serial port) 💡 You see, there is no way of getting out of proper cybersecurity documentation anymore. As soon as your device has a kind of data interface, you should apply the FDA premarket guidance for cybersecurity (https://lnkd.in/essp-EGB) together with the new requirements of the new paper. #usfda #cybersecurity #medicaldevices #samd #healthtech

US pharma giant Cencora says Americans’ health information stolen in data breach "U.S. pharmaceutical giant Cencora says it is notifying affected individuals that their personal and highly sensitive medical information was stolen during a cyberattack and data breach earlier this year." Are we done wondering why people are pushing back on providing data to organizations that have created processes that require us to give it to them ... even though we dont trust them? An very real ethical dilemma has been created by this lack of responsibility and accountability ... data poisoning ... thats where people provide false data to organizations that demand their data for a service or product. If you collect it, or use it, or share it, its YOUR responsibility to protect it ... #privacy #security #leadership #cybercrime #ethics https://lnkd.in/eaJW5PGj

It’s been quite a year for US Cybersecurity!   March 2023 On 2023-MAR-29, #fda issued a short draft guidance called the #cybersecurity refuse to accept (RTA). This described #fda’s decision to refuse to accept premarket applications that do not contain the objective evidence #fda needs to evaluate a manufacturer’s cybersecurity efforts.   This guidance is no longer available on #fda’s website. It was superseded by the publishing of the finalized guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions and updated guidance Electronic Submission Template for Medical Device 510(k) Submissions (see below).   September 2023 On 2023-SEP-27, #fda finalized Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (https://lnkd.in/gnKxt7hq). This guidance describes recommendations regarding the #cybersecurity information to be provided for devices under premarket submission. It is an incredibly comprehensive document that links to additional free and purchasable resources. Appendix 4, Table 1 Recommended Premarket Submission Documentation provides a list of specific records #fda expects to see upon submission.   October 2023 On 2023-OCT-02, #fda released an update to Electronic Submission Template for Medical Device 510(k) Submissions (https://lnkd.in/gm7r5QKB). Known as the #eSTAR guidance, this update mandated that all submissions after 2023-OCT-02 use the #eSTAR template for all premarket notification (510(k)) submissions.   The update of this guidance document, in combination with the finalization of the Cybersecurity in Medical Devices guidance, provides #fda a more automated mechanism (#eSTAR) to mandate specific #cybersecurity records. With the #eSTAR template, the submission will automatically be rejected if specific records aren’t included, thus negating the need for all #fda RTA efforts.   February 2024 On 2024-FEB-26, #nist updated their Cybersecurity Framework to V2.0 (https://lnkd.in/gVJ9_zTb). The NIST Cybersecurity Framework (CSF) 2.0 provides guidance to industry, government agencies and other organizations to manage cybersecurity risks. It is essential for medical device manufacturers to understand how this framework interacts with their medical devices.   Call to Action So, what is a manufacturer to do next? Even if you have just received clearance, you will have software updates to your device that may eventually need to be submitted to FDA in a new 510(k). 1. Review Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. 2. Review the NIST Cybersecurity Framework (CSF) 2.0. 3. Perform a gap assessment of the quality system and current software design history records. 4. Update SOPs and #cybersecurity records. 5. Subscribe to receive updates from organizations dealing with #cybersecurity (#imdrf, #fds, #nist, etc.)

🌟 Elevating Pharmaceutical Operations with Optimum Origen's MSP and 24-Hour Help Desk Services 🌟 In the fast-paced world of pharmaceuticals, seamless IT operations are paramount to success. Optimum Origen is here to empower pharmaceutical companies with top-tier Managed Service Provider (MSP) solutions and round-the-clock Help Desk services. 🔒 Advanced Cybersecurity Measures: Safeguarding sensitive pharmaceutical data is our top priority. Optimum Origen implements robust cybersecurity protocols to protect against cyber threats and ensure compliance with industry regulations. 💻 Proactive Monitoring and Maintenance: Our MSP services provide proactive monitoring of IT infrastructure, ensuring optimal performance and minimizing downtime. With real-time alerts and regular maintenance, pharmaceutical operations run smoothly without interruption. 👨💻 24-Hour Help Desk Support: Pharmaceuticals don't rest, and neither do we. Our dedicated Help Desk team is available 24/7 to address any IT issues or concerns, providing prompt resolutions and peace of mind around the clock. 🌐 Scalable Solutions for Growth: As pharmaceutical companies expand and evolve, our MSP services scale with them. Whether it's managing new technologies, integrating acquisitions, or adapting to regulatory changes, Optimum Origen ensures seamless growth transitions. 💡 Tailored Solutions for Unique Needs: We understand that every pharmaceutical company has its own set of challenges and requirements. That's why we work closely with our clients to tailor MSP and Help Desk solutions that align perfectly with their specific needs and objectives. With Optimum Origen as your trusted MSP partner, pharmaceutical companies can focus on their digital transformation and data analysis – while we handle the IT infrastructure with expertise and dedication. Let us manage your IT, so you can manage your operations on time and flawlessly. Ready to elevate your pharmaceutical operations? Contact Optimum Origens Inc. today to learn more about how our MSP and Help Desk services can drive success for your organization. 🤝 #OptimumOrigen #MSP #HelpDesk #Pharmaceuticals #ITServices #Cybersecurity #HealthcareIT

I am excited to present our latest two-part pharmind article on cybersecurity in the pharmaceutical industry, co-authored by Holger Mettler and Dr. Christopher Steck. Pharmaceutical companies play a vital role in public health, and some are classified as critical infrastructure (KRITIS), making them prime targets for cyberattacks. In our article, we explore how the IEC 62443 standards can help secure industrial networks and systems, ensuring operational availability and safeguarding patient safety. We also provide a practical guide for implementing these standards from the perspective of a pharmaceutical asset owner. #Exyte #CyberSecurity #IEC62443

Data breaches and ransomware attacks have indeed become a significant concern globally, with the healthcare and pharmaceutical sectors being particularly vulnerable due to the sensitive nature of the data they handle. Check Article: https://lnkd.in/gHXDFtYz Pooja Chatrath, CIO of Information Technology at Oncquest Laboratories Ltd., addresses these issues in her discussion. Check video: https://lnkd.in/gjddwXUz In the video, Chatrath highlights several key security concerns and strategies to mitigate these risks: Current Security Concerns: ➡ Data Breaches: The increasing frequency of cyber-attacks targeting patient data. ➡ Ransomware Attacks: The growing threat of ransomware, which can cripple healthcare services by encrypting crucial data and demanding a ransom. ➡ Insider Threats: The potential risks posed by employees who might misuse access to sensitive information. Need for Robust Access Controls: ➡ Password Policies: Implementing strong password policies to ensure that passwords are complex and changed regularly. ➡ Multi-Factor Authentication (MFA): Adding an extra layer of security by requiring multiple forms of verification before granting access to sensitive systems. ➡ Data Encryption: Encrypting data both at rest and in transit to protect it from unauthorized access and breaches. Additional Security Measures: ➡ Security Audits: Regular audits to identify and address vulnerabilities within the system. ➡ Penetration Testing: Conducting penetration tests to simulate attacks and assess the effectiveness of security measures. ➡ Employee Training: Educating staff about cybersecurity best practices and how to recognize potential threats. By implementing these strategies, healthcare and pharmaceutical organizations can better protect their data, maintain patient privacy, and reduce the risk of cyber-attacks. The emphasis on proactive measures such as audits and training is crucial in creating a security-conscious culture within these sectors. Sophos Anjali Sethi Joshi Puja Bhardwaj #heatlthcare #pharma #genAI #generativeAI #cio #ciso #cto #techleaders #ITsecurity #Cybersecurity #Infosec #DataProtection #AISecurity #ThreatIntelligence #Cybercrime #Cyberattacks #DigitalSecurity #Phishing #RiskManagement #DataBreach #Passwords #NetworkSecurity #CybersecurityAwareness #InformationSecurity #DataPrivacy #InfoSecurity #Hacking #CloudSecurity #Malware #Ransomware #AIinnovation #AItechnology #GenerativeAI #AIdevelopment #ArtificialIntelligence #AIresearch #FutureofAI