by Mark Heinemann | 6 Feb, 2020 | CHCUK News & Articles, Consultation, Data Privacy, News, NIS, PASS, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Intelligence
2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug...
by Syneos Health_1 | 26 Jun, 2019 | Data Privacy
Thailand’s Personal Data Protection Act, B.E. 2562 (2019) (“PDPA”) has been published in the Government Gazette on 27 May 2019. Timeframe With very few exceptions, companies and organizations collecting, using, disclosing, and/or transferring...
by Syneos Health_1 | 19 Nov, 2018 | Brexit, CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent, eletronic Signatures
MHRA/HRA Joint statement on seeking eConsent – A joint MHRA/HRA statement (eConsent Statement) has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods. It has become apparent that eConsent...
by Syneos Health_1 | 19 Nov, 2018 | Data Privacy, GDPR
The US Office for Human Research Protections (OHRP) has compiled a very useful list of the country-by-country guidelines and supporting information on the impact of the EU General Data Protection Regulation (GDPR) If you are new to the General Data Protection...
by chuck_ltd | 22 Aug, 2018 | CHCUK News & Articles, Data Privacy, Informed Consent, NIS
France – Health Research and Data Protection: Lawmakers Revise Research Standard MR-003 “Research in the Field of Health Without Collection of Consent” By Mark Heinemann, Principal Consultant, Real World Clinical Consulting, Syneos Health The French Data Protection...
by chuck_ltd | 15 Apr, 2018 | CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent
While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies,...
by chuck_ltd | 13 Jan, 2017 | CHCUK News & Articles, Data Privacy, HIPAA, News
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) has announced its first Health Insurance Portability and Accountability Act (HIPAA) settlement of the year regarding the untimely reporting of a breach of unsecured protected health...
by chuck_ltd | 3 Jan, 2017 | CHCUK News & Articles, Data Privacy, News
The United States has traditionally taken a libertarian approach to data privacy: “what is not forbidden is permitted.” Outside sensitive sectors such as health (HIPAA) and finance (GLBA), the United States was historically content to let the market police itself. The...
by chuck_ltd | 18 Oct, 2016 | CHCUK News & Articles, Data Privacy, News
Last week, the HHS Office of Civil Rights (OCR) released its long-awaited “Guidance on HIPAA & Cloud Computing” (Guidance). Using 11 questions and comprehensive responses, the Guidance details OCR’s position on the obligations of covered entities and business...
by chuck_ltd | 30 Aug, 2016 | CHCUK News & Articles, Data Privacy, News
The European Commission has drafted a code of conduct on privacy for mobile health (mHealth) apps (the “Code”). The Code has been submitted to the Article 29 Data Protection Working Group for approval. The Code aims to provide a user friendly guide to compliance with...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, Data Privacy
Another Record HIPAA Settlement, Another Reminder to Keep Electronic PHI Secure 4 August 2016, the US Department of Health & Human Services’ Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois’ largest healthcare system) will pay a...
by chuck_ltd | 10 May, 2016 | CHCUK News & Articles, Data Privacy, News, Virtual Clinical Research
The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The...
by chuck_ltd | 29 Apr, 2016 | CHCUK News & Articles, Data Privacy, EHR, Virtual Clinical Research
The Electronic Health Record Sharing System Ordinance came into effect on 2 December 2015. The Ordinance provides the legal framework for public and private hospitals and other healthcare providers to collect, share and keep patient’s electronic health record...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, Cybersecurity, Data Privacy, Digital Health Technology, Medical Apps, News, Virtual Clinical Research
Strasbourg, 2 February 2016 The European Commission and the United States have agreed on a new framework for transatlantic data flows: the EU-US Privacy Shield. Today, the College of Commissioners approved the political agreement reached and has mandated...
by chuck_ltd | 15 Jan, 2016 | CHCUK News & Articles, Data Privacy, News
In December 2015, a journalist disclosed one patient’s health data in a TV show. The data were related to the patient’s mental health and his treatment in the mental health clinic “Dr Laza Lazarevic”, in Belgrade. The Serbian Commissioner for...
by chuck_ltd | 15 Jan, 2016 | CHCUK News & Articles, Data Privacy, News
The European Court of Justice ruled in October 2015 that its ‘safe harbour’ agreement with the US, that allowed the transfer of EU citizens’ data to the US, is no longer valid because it does not adequately protect consumers. This decision was made in the wake of the...
by chuck_ltd | 21 Dec, 2015 | CHCUK News & Articles, Data Privacy, News
Though the U.S. Department of Health and Human Services Office for Civil Rights (OCR) has told organizations to expect the Phase 2 HIPAA audits soon for almost two years now, it appears that the audits truly are around the corner. In September, OCR Director Jocelyn...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Data Privacy, News
Source: Law-Now Yesterday evening a political agreement about new EU data protection rules was reached following final negotiations between the Parliament, the Council and the Commission (the so-called ‘trilogue’ meetings). The new rules will be set out...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence
Non-interventional studies (NIS) are a key tool for collecting information about how a drug is actually used (+ safety, effectiveness, healthcare benefit and value etc…) once it’s been approved (e.g., by FDA in the USA) and accepted for reimbursement...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence, Virtual Clinical Research
On 16 October 2015, CMS hosted a conference on the implications of the European Commission’s plans to create a Digital Single Market. The conference generated meaningful discussions on the true impact, reality and consequences of the proposed framework. Key figures...
by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, Medical Apps, News, NIS, Real Word Evidence, Virtual Clinical Research
Commission Welcomes Agreement to Make EU Online Environment More Secure European Commission – Press release Brussels, 8 December 2015 Negotiators of the European Parliament, the Council and the Commission have agreed on the first EU-wide legislation on...
by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence
The revised Health Information and Patient Safety Bill, as drafted, will grant certain researchers the ability to obtain personal data without the consent of the relevant individual. The Bill envisages that the Data Protection Commissioner will have a role in...
by chuck_ltd | 7 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice. This guidance covers common inspection...
by chuck_ltd | 24 Nov, 2015 | CHCUK News & Articles, Data Privacy, News
Corrs Chambers Westgarth – Helen Clarke Understandably most people are sensitive about protecting their personal health information. For this reason, Australia’s privacy laws give heath information a higher level of protection than other types of personal data....
by chuck_ltd | 18 Nov, 2015 | CHCUK News & Articles, Data Privacy, News, NIS
Background On October 6 2015 the European Court of Justice (ECJ) ruled that the European Commission decision on the adequacy of the EU-US safe harbour framework is invalid. ECJ Decision In Maximillian Schrems v Data Protection Commissioner (Case C-362/14) the ECJ held...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Pragmatic Trials, Real Word Evidence
Morrison & Foerster LLP – Paul D. McKenzie and Wei Zhang One of the more dramatic privacy law developments in China in 2014 was the August criminal conviction of foreign nationals Peter Humphrey and Yu Yingzeng for their violation of Article 253 of the...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, Medical Apps, News, Pragmatic Trials, Real Word Evidence
Buchalter Nemer – Kathleen Juniper Smart medical devices that can deliver health care services are increasingly consumer friendly. Using the latest technologies and sophisticated algorithms, some devices are capable of collecting data directly from consumers...
by chuck_ltd | 6 Nov, 2015 | CHCUK News & Articles, Data Privacy, News
Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations involving the promotion of the company’s...
by chuck_ltd | 6 Nov, 2015 | CHCUK News & Articles, Data Privacy, News
The Information Commissioner has issued a monetary penalty notice (MPN) of £130,000 to Pharmacy2U, the UK’s largest NHS approved online pharmacy, after it sold the details of 21,500 customers to third-parties through an online marketing company. The...
by chuck_ltd | 4 Nov, 2015 | CHCUK News & Articles, Data Privacy, News
This business resource explains the requirements under the Privacy Act 1988 (Cth) (Privacy Act) for private sector health service providers or other private sector organisations who are seeking to collect, use or disclose health information without consent for...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines
We are on the cusp of introducing a mechanism to disclose value transfers between health professionals and EFPIA Member Companies. But, with the June 2016 deadline looming, learning from those who are already experiencing this form of transparency could save us...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines
Although the Big Data revolution is only in its early days, the potential for value creation is huge in the healthcare sector. Not only can clinical data help us to understand diseases and develop therapies; it can also drive the transition towards modern health...
by chuck_ltd | 8 Oct, 2015 | CHCUK News & Articles, Data Privacy, Publication Guidelines
Version 3 of Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP3) was published on 15 September 2015. This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for...
by chuck_ltd | 7 Oct, 2015 | Data Privacy
Source: Schneider on Security On 6th October 2015, the European Court of Justice ruled that sending personal data to the US violates their right to privacy: The ruling, by the European Court of Justice, said the so-called safe harbor agreement was flawed because it...
