Connecting for Better Health’s Post

Have you seen our white paper, Consent-to-Share: California’s Opportunity to Modernize Cross-Sector Data Sharing? #Consent is key to linking clinical and social services data for better health outcomes. Our research highlights critical insights and calls for action: ✅ Accelerate adoption of state legal consent interpretations ✅ Advance tech & policy for consent management ✅ Standardize consent forms ✅ Build consent programs with state agencies

Jeremy Sherer and Amy Joseph were published in Reuters Legal and Thomson Reuters Westlaw, “Digital health forecast 2024: legal implications of technological, policy, and business developments” Read the article here: https://bit.ly/49FHFj4 #healthlaw #digitialhealth #telehealth #digitalhealthforecast #digitialhealth2024

Health care provider organizations and social service agencies MUST take #patientconsent selections seriously to safeguard #healthprivacy! New white paper from Midato Health's Carol Robinson and Cindy Throop covers best practices for consent management for the use and disclosure of sensitive health-related data, including keeping data fields separate, appropriately using multi-party consent forms, knowing when to use tailored consent forms for specific purposes, and more. Read the paper at https://bit.ly/consentmgmt 

Consent is an issue we must confront in California and across the nation to effectively link clinical and social services data and promote collaboration for better overall health. Check out C4BH’s Advancing #Consent Management in California research to learn more and get involved. Our top policy recommendations include:  -Accelerate the adoption of state legal interpretations of consent to share -Advance technology and policy for consent management -Develop standardized consent forms -Establish statewide consent management programs in collaboration with agencies beyond CalHHS Center for Data Insights and Innovation https://lnkd.in/ex98_3Hq

It isn’t informed consent if the patient doesn’t understand the information. How can we help them understand it?💭   🌟“Information is best communicated through conversation, visuals and text. Written information, be it digital or printed, should be accessible and meet BRAN (Benefits, Risks, Alternatives, do Nothing) principles. This includes the use of written information and electronic web-based information systems that provide invaluable details of procedures, options, risks and potential complications. These systems are, in the current climate, an invaluable tool in providing safe and effective informed consent. The use of multimedia tools, diagrams and videos allows patients to consider their care and decision making at their own pace and prepare any questions’ they may have.”🌟   This quote is taken from EIDO Healthcare’s Consent Review, a free resource that explores the impact of notable court cases since the landmark Montgomery vs Lanarkshire Health Board ruling in 2015.⚖️   Download the Consent Review today to learn more about key court cases with consent at their centre and what lessons you can take from them to help your patients and practice.🤝   https://lnkd.in/e4AgR4_B #InformedConsent #PatientUnderstanding

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies https://bit.ly/44LRhaz #health #data #bioavailability

Don't let this headline be YOU! Headline: Palm Beach Health Sued for Alleged Use of Meta Pixel Tracking Code on Patient Portal Allegedly,  Palm Beach Health added the tracking code to its patient portal and the code collected information such as patient medical test results, diagnoses, website searches, and IP addresses. Then the protected personal information was sold to advertisers. The lawsuit is  Prosky v. Palm Beach Gardens Community Hospital, Inc. et al.(Alder, HIPAA Journal, 5/20/2024). The HHS’ Office for Civil Rights states that  tracking technologies can only be used  with patient’s  authorization  and when disclosure is permitted by HIPAA.  A business associate agreement must be in place with the provider of the tracking technology. Also, disclosure should be clearly stated in the organization’s privacy notice. What is a Business Associate? That is a subcontractor who routinely has access to protected patient identifying information.  Business associates who violate HIPAA may be subject to penalties of $127 to over $1,919,173 per violation  ( 45 CFR §§ 160.404 and 102.3 ). Ouch. DLH-Enterprises5150.com

Exciting news, because nothing gets my heart racing like a well-executed informed consent! The FDA has just released a new guidance document "Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards"   (If this proposed rule finalized, it would harmonize the FDA’s regulations on human subject protections with the revised HHS Common Rule.) Let's dive into 3 examples of ways you can present the key information section in an ICF: Structured Summary: Present key information in a structured format, providing bullet points or headings for easy navigation. This approach ensures essential details are prominently displayed, aiding participants in understanding the trial's purpose, procedures, risks, and benefits.    Visual Aids: Utilize visual aids such as infographics or flowcharts to complement written information. Visual representations can enhance comprehension, particularly for complex concepts or procedures, empowering participants to make informed decisions about their participation in the trial.    Plain Language: Communicate key information using clear and concise language, avoiding technical jargon or complex terminology. This approach promotes accessibility and comprehension, ensuring participants from diverse backgrounds can fully understand the information presented and actively engage in the informed consent process. Let's leverage this new guidance to enhance the quality and effectiveness of our research endeavors! https://lnkd.in/eaJJmyM8 #ClinicalResearch #FDA #InformedConsent #GuidanceDocument #EfficiencyTips

📢AGENDA RELEASED for the Global Clinical Trial Disclosure and Data Transparency Conference! Join us for this essential event where industry leaders and experts will delve into the latest in #clinical #trialdisclosure and #datatransparency. From #regulatory updates to best practices in data sharing, this conference is a must-attend for anyone committed to advancing #transparency in #clinicalresearch. View #CTD24 agenda at: https://ow.ly/GJxN50SCEUW

𝗜𝘀𝗿𝗮𝗲𝗹’𝘀 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗠𝗼𝗯𝗶𝗹𝗶𝘁𝘆 𝗟𝗮𝘄: 𝗔 𝗟𝗲𝗮𝗽 𝗙𝗼𝗿𝘄𝗮𝗿𝗱 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 This month, the Israeli Ministry of Health Committee passed the 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗠𝗼𝗯𝗶𝗹𝗶𝘁𝘆 𝗟𝗮𝘄, enhancing efficiency in the Israeli healthcare system. By reducing duplicate tests and treatments, this law 𝘀𝗮𝘃𝗲𝘀 𝘁𝗶𝗺𝗲 𝗮𝗻𝗱 𝗿𝗲𝘀𝗼𝘂𝗿𝗰𝗲𝘀 𝘄𝗵𝗶𝗹𝗲 𝗲𝗻𝗵𝗮𝗻𝗰𝗶𝗻𝗴 𝗱𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗮𝗻𝗱 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁 𝗮𝗰𝗰𝘂𝗿𝗮𝗰𝘆. With this reform, individuals can seamlessly transfer their personal medical information between providers, granting physicians immediate access to comprehensive patient histories. This new legislation opens exciting opportunities for 𝗜𝘀𝗿𝗮𝗲𝗹𝗶 𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, driving improved care and efficiency while navigating patient privacy concerns. Discover more about this transformative law here: https://lnkd.in/dsz_wZ7N #𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 #𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 #𝗠𝗲𝗱𝗶𝗰𝗮𝗹𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻𝗣𝗼𝗿𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 #𝗗𝗶𝗴𝗶𝘁𝗮𝗹𝗛𝗲𝗮𝗹𝘁𝗵 #𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲𝗦𝘆𝘀𝘁𝗲𝗺 #𝗛𝗲𝗮𝗹𝘁𝗵𝗗𝗮𝘁𝗮 #𝗛𝗲𝗮𝗹𝘁𝗵𝗦𝘁𝗮𝗿𝘁𝘂𝗽𝘀 #𝗜𝘀𝗿𝗮𝗲𝗹𝗶𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲