Risk Evaluation and Mitigation Strategies

• Trustwave , a leading cybersecurity and managed security services provider, today released comprehensive research shedding light on the distinctive cybersecurity risks encountered by the hospitality industry.
• In its new research, Trustwave SpiderLabs has documented the attack flow utilized by threat groups, exposing their tactics, techniques, and procedures.
• From brute forcing to exploiting known vulnerabilities to attacking exposed open ports, these persistent threats pose significant risks to the hospitality industry.
• Franchise Model: The franchise framework leads to disparities in policy consistency and implementation across the industry, including cybersecurity measures.

• Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process.
• Once new drugs are approved for marketing in Canada, Health Canada continues to monitor them.

Clinical trials

• Potential new drugs are assessed in clinical trials before they can be authorized for sale in Canada.
• In addition, clinical trials often leave out children, the elderly, women, minority groups, people with disabilities and multiple other groups.
• Usually only 3,000 to 5,000 people are exposed to an experimental drug in clinical trials.

Drug safety programs

• That’s why when regulatory agencies like Health Canada approve a drug, they require the drug company to monitor post-market safety.
• These programs go by various names; in Canada and Europe they are Risk Management Plans (RMP) and in the United States they are Risk Evaluation and Mitigation Strategies (REM).
• Under these plans companies may have to conduct additional safety studies, set up registries to identify patients who are taking the drug, develop educational materials for health care professionals and/or patients, restrict access to the drug and commit to undertaking a number of other measures.

Access to drug monitoring information

• In the U.S., people can turn to a Food and Drug Administration website that lists all the drugs with REMS.
• Click on a hyperlink and it takes you to a summary of the RMP for the drug in question.
• Two of Health Canada’s stated goals in implementing a system of RMPs are to “support Canadians’ timely access to safe, efficacious and high quality drugs and support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products.” But without access to current information on specific drugs, Canadians cannot assess those risks for themselves, nor can they evaluate the monitoring program.
• But Health Canada does not need to wait until then to make this information available to Canadians.

• Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
• The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application.
• The incidence of grade ≥3 QT prolongation events was low, with uncommon ventricular arrythmia events.
• Overall, the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.

• Understanding Extended Reality Technology & Data Flows: * *Privacy and Data Protection Risks and Mitigation Strategies This post is the second in a two-part series.
• However, these technologies often depend on sensitive personal information, and the collection, processing, and transfer of this data to other parties may pose privacy and data protection risks to both users and bystanders.
• This post examines the XR data flows that are featured in FPFs infographic, and analyzes some of the data protection, privacy, and equity issues raised by the data that is processed by these devices, as well as strategies for mitigating these risks.
• *Key risks include: Sensitive inferences: XR devices collect, process, and share large quantities of data about users bodies and environments.
• Privacy-enhancing technologies ( PETs Bystander protections: Designing XR devices so that they ensure bystanders data is not unduly collected.
• Processing Large Volumes and Varieties of Sensitive Personal Data
  XR technologies raise traditional privacy and data protection risks, but also implicates larger questions around surveillance, social engineering, and freedom of expression.
• While these transmissions of data may improve a users XR experiences, they can also create new privacy and data protection risks for users and bystanders.
• Eye tracking underpins many current and future-facing use cases, such as enhanced graphics, expressive avatars, and personalized content, but it may pose privacy and data protection risks to users.
• Bystander and Environmental Data
  Bystanders privacy can also be impacted when XR devices and third parties collect and process sensor data.
• Some of the privacy and data protection issues affecting bystanders mirror the privacy risks to XR users.
• Strategies for Mitigating Risks
  Organizations that provide XR technologies can implement a number of strategies to address the risks raised by XR data collection, use, and sharing.
• V. Conclusion
  The complex web of data, sensors, algorithms and automated systems, and parties that enable important and sometimes central XR functions also can raise privacy and data protection concerns.
• Understanding Extended Reality Technology & Data Flows: * *Privacy and Data Protection Risks and Mitigation Strategies