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Health Research
Health research aims to find better ways to treat, prevent and cure disease.
This vital component of healthcare can take multiple forms and present a variety of risks and opportunities. Whether it is a clinical trial, secondary data research, research ethics board protocol review, or a material transfer agreement, we keep the aims of the study top of mind while advising researchers, funders, and health care organizations. We also advise on deidentification of data for research purposes, and questions of research versus quality.
Our services include:
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Agreements - Material transfer, clinical trial, data sharing, basic science
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Research ethics board advice
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Research misconduct
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Protocol reviews
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Informed consents
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Deidentified data
Connect with our team
Mary Jane Dykeman
Samara Starkman
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Privacy for the Future is for you if:
You find that digital technologies are increasingly important for your business or your organization
You are increasingly working with cross-border partners and collaborators
You are a health care organization with questions about how best to contract and work with your service providers, or vice versa
You want guidance on emerging privacy and data issues in clinical research
The
Series Overview
In this series, you will gain valuable insights into (1) Canada-US cross-border privacy compliance, (2) the privacy and security challenges created by the use of software and connected and smart devices in healthcare, (3) service provider relationships in health care, and (4) clinical research privacy and compliance for the modern age. Ira and Mary Jane will unpack these hot topics and provide concrete, practical, innovation-minded guidance on how to navigate them.
Your Instructors
Ira Parghi is a partner at INQ Law. She has over 20 years of experience practicing both information law and health law and is admitted to practice in Ontario, California, and New York.
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Ira’s information law practice focuses on privacy compliance (including complex United States-Canada cross-border privacy issues), the prevention and management of privacy breaches (including ransomware and other cybersecurity incidents), the use and sharing of data in clinical research, and data governance. She advises clients on matters ranging from breach prevention and incident response to complex data-sharing agreements, the adoption of “smart” technologies, access to information requests, research contracts, data-related due diligence on corporate transactions, and the Canadian privacy compliance obligations of foreign companies operating in Canada. Her clients include medical technology companies, pharmaceuticals, retail pharmacies, private equity firms, hospitals, health care providers and organizations, research institutes, independent schools, school boards, colleges, retirement homes, non-profits, and municipalities. Ira is expert in a wide range of privacy laws, including PIPEDA, PHIPA, MFIPPA, FIPPA, and US legislation such as HIPAA. She has successfully represented numerous clients before federal and provincial/state regulators in both Canada and the United States.
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Ira’s health law practice focuses on clinical risk issues and adverse incident management, including large-scale lookback reviews and patient notifications. Ira frequently serves as a trusted advisor to senior administrative and clinical leadership in hospitals and health care organizations, advising on issues management, board and internal stakeholder engagement, media relations, legal compliance, regulatory reporting, and patient and client relations. She also has extensive litigation experience and has argued various matters before tribunals and the courts, including the Ontario Court of Appeal.
Ira regularly speaks, teaches, and writes on emerging privacy and security issues, cross-border privacy, and cybersecurity incident prevention and management.
Prior to joining INQ Law, Ira worked as the Corporate Privacy Officer at a large US health network, a lawyer in the health care group of a global law firm based in the United States, and a lawyer in the health law group of a large Canadian law firm.
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MPP, BA, LLB
Ira Parghi
Partner, INQ Law
BA (Hons), JD
Mary Jane Dykeman
Managing Partner, INQ Law
Mary Jane Dykeman is a managing partner at INQ Law. In addition to data law, she is a long-standing health lawyer.
Her data practice focuses on privacy, artificial intelligence (AI), cyber preparedness and response, and data governance. She regularly advises on use and disclosure of identifiable and de-identified data. Mary Jane applies a strategic, risk and innovation lens to data and emerging technologies. She helps clients identify the data they hold, understand how to use it within the law, and how to innovate responsibly. In her health law practice, Mary Jane focuses on clinical and enterprise risk, privacy and information management, consent, capacity and substitute decision-making, and counseling through difficult situations, including at the end of life. She has acted as in-house counsel to two Toronto teaching hospitals and was instrumental in the development of Ontario’s health privacy legislation.
Mary Jane regularly consults on large data initiatives and use of data for health research and quality purposes. Her consulting work extends to modernizing privacy legislation and digital societies, and she works with Boards, CEOs and CIOs on the emerging risks and trends in data. Mary Jane regularly speaks on AI, cyber risk and how to better engage and build trust with clients and customers whose data is at play. She is also a frequent speaker and writer on health law and data law.
Discover the
Privacy for the Future
Webinar Series
SCHEDULE & DETAILS
Health Privacy in a Digital Age I
MOBILE APPS
DATE: APRIL 27, 2022 TIME: 12-1pm EST
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The regulatory framework
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Privacy and security requirements and best practices
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Enforcement activity and culture
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What tech companies and health care organizations should focus on: areas of risk, top priorities, next steps
Health Privacy in a Digital Age II
CONNECTED AND SMART DEVICES
DATE: MAY 4, 2022 TIME: 12-1pm EST
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Contractual and litigation liability
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The regulatory framework
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Privacy and security requirements and best practices
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What tech companies and health care organizations should focus on: areas of risk, top priorities, next steps
Health Privacy Across Borders I
A PRIMER FOR CANADIAN ENTITIES OPERATING OR DOING BUSINESS IN THE US
DATE: MAY 11, 2022 TIME: 12-1pm EST
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The “business associate” designation under HIPAA
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HIPAA requirements for business associates
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Other federal regulators/laws
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State laws
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Enforcement activity and culture
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What Canadian entities operating or doing business in the US should focus on: areas of risk, top priorities, next steps
Health Privacy Across Borders II:
A PRIMER FOR US ENTITIES OPERATING OR DOING BUSINESS IN CANADA
DATE: MAY 18, 2022 TIME: 12-1pm EST
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The regulatory framework
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Speaking Canadian: how to think about Canadian compliance obligations
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Privacy and security requirements and best practices
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Enforcement activity and culture
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What US entities operating or doing business in Canada should focus on: areas of risk, top priorities, next steps
Hot Topics in Health Privacy I
SERVICE PROVIDER RELATIONSHIPS
DATE: JUNE 1, 2022 TIME: 12-1pm EST
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Privacy and security requirements and best practices
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Breach management considerations
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Cross-border outsourcing
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Privacy legislation amendments that will affect the service provider relationship
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What health care organizations and their service providers should focus on: areas of risk, top priorities, next steps
Hot Topics in Health Privacy II
CLINICAL RESEARCH
DATE: JUNE 8, 2022 TIME: 12-1pm EST
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Privacy and security requirements and best practices
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Data governance considerations
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Canada-US cross-border clinical research: privacy, consent, and compliance considerations
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What entities involved in clinical research should focus on: areas of risk, top priorities, next steps
Ask us about CLE credits!
Register for all 6 webinars, or for a specific topic:
6
LIVE WEBINARS
PACKAGE
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Six live 1-hour webinars with Instructor Q&A
Six webinar slide decks
Access to webinar recordings until June 2023
$599