patient privacy in a mobile world a framework to address privacy law issues in mobile health

116 Pages·2013·1.73 MB·English

PATIENT PRIVACY
IN A MOBILE WORLD
A FRAMEWORK TO ADDRESS
PRIVACY LAW ISSUES
IN MOBILE HEALTH
JUNE 2013

PATIENT PRIVACY
IN A MOBILE WORLD
A FRAMEWORK TO ADDRESS
PRIVACY LAW ISSUES
IN MOBILE HEALTH
JUNE 2013

ACKNOWLEDGEMENTS

Thomson Reuters Foundation and the TrustLaw Connect team are truly grateful
to each of the partners that contributed to and collaborated on this work:

mHealth Alliance identified the need to examine this important issue and
brought their expertise on mobile health in the global arena. We truly value
their collaborative approach and ability to engage with multiple stakeholders to
deliver this project.

Baker & McKenzie and Merck dedicated significant resources as the
international coordinators for this project, bringing a wealth of legal and
commercial expertise on health, privacy and data protection laws. Baker &
McKenzie also carried out the research for the Chilean and Peruvian case studies
in this report.

Doulah & Doulah for the Bangladesh research, MMAKS for the Ugandan
research, Nisith Desai for the Indian research, Templars for the Nigerian
research and Ubena John, Doctoral Candidate at Stockholm University for the
Tanzanian research.

The mHealth Alliance wishes to acknowledge a number of individuals who
contributed to the production of this publication. First, we would like to thank
Kathy Calvin, President and CEO of the United Nations Foundation, whose
initial conversations with Monique Villa, President of the Thomson Reuters
Foundation, led to the development of the TrustLaw Connect project that
forms the basis for this publication. We also want to acknowledge and thank
Patricia Mechael, Executive Director of the mHealth Alliance, whose leadership
in addressing concerns around privacy, confidentiality and data security as key
iv PATiENT PRivACY iN A MOBiLE WORLD – A FRAMEWORK TO ADDRESS PRivACY iSSUES iN MOBiLE HEALTH
barriers to using mobile technology launched the work of the Alliance and led
to the engagement with Thomson Reuters Foundation, Baker & McKenzie and
Merck. The Alliance also wishes to thank William Philbrick, who, on behalf of
the Alliance, oversaw and managed the project that led to this publication.
His efforts were part of a larger team effort that included Chelsea Hedquist,
Jon Payne, Madhu Deshmukh, Shariq Khoja, Avrille Hanzel, Adele Waugaman,
Madhura Bhat, Francis Gonzales, Chelsea Solmo and Sarah Struble.

Baker & McKenzie is proud to contribute to this paper and the efforts of the
mHealth Alliance in championing the use of mobile technologies to improve
health throughout the world. A very special thank you is due to the TrustLaw
Connect network of the Thomson Reuters Foundation for organizing the project
and undertaking the process of assembling the contributing lawyers. Baker
& McKenzie is deeply grateful to Merck and its global team for co-leading this
project and providing constant input and support. Also, this paper could not
have been completed without the essential contributions of Doulah & Doulah
from Bangladesh, MMAKS Advocates from Uganda, Nisith Desai Associates
from India, Templars from Nigeria and Ubena John from Tanzania. Finally, we
would like to thank the following individuals who comprised our global team:
Michael J. Wagner (Chicago), Brian Hengesbaugh (Chicago), Karen Sewell
(Chicago), Kate O Suilleabhain (Chicago), Amy de La Lama (Chicago), Peter R.
George (Chicago), Lindsay M. Martin (Chicago), Jacqueline M. Wilkosz (Chicago),
Deanna Bougie (Chicago), Erin Boo (Chicago), Teresa Tovar (Lima), Jorge Ossio
(Lima), Viviana Chavez (Lima), Christoph Rittweger (Munich), Julia Wendler
(Munich), Katherine T. Sakoda (Palo Alto), Antonio Ortuzar, Jr. (Santiago), and
Rafael Pastor (Santiago).

Merck wishes to express appreciation to both the mHealth Alliance and
the TrustLaw Connect network of the Thomson Reuters Foundation
for the opportunity to work on this important project, as well as the
PATiENT PRivACY iN A MOBiLE WORLD – A FRAMEWORK TO ADDRESS PRivACY iSSUES iN MOBiLE HEALTH v
excellent collaboration by both organizations throughout its planning
and implementation. In addition, we wish to acknowledge the invaluable
contribution made by Baker & McKenzie as well as the other participating law
firms. Finally, but not least, we at Merck are very proud of the contribution
made to the project by a global team including colleagues from our Office of
General Counsel and Global Compliance Organization, in several locations in
the US, Europe and Asia Pacific regions. As such, this project is an important
milestone in the ongoing expansion and globalization of Merck’s long
standing legal pro bono program.

We acknowledge the contribution of all of the partners involved in the project
and especially Nasir and Amina, partners at Doulah & Doulah, for the local
research. Special thanks go to Karen Sewell at Baker & McKenzie and Serena
Grant and Dianne Marcos at the Thomson Reuters Foundation for taking up
the toughest job of cross-border co-ordination and consolidation.
MMAKS Advocates acknowledges the work of Mr. Phillip Karugaba and Ms.
Gloria Matovu who volunteered on the mHealth Alliance Research.

We would like acknowledge the following members of the Templars team
— Olumide Akpata, Ijeoma Uju, Chioma Oparadike, Oyeyemi Immanuel and
Ebuka Uyanwa — for their contributions to this project.

DiSCLAiMER

The material in this paper is of the nature of general comment only and is not intended to be
a comprehensive exposition of all potential issues, nor of the law relating to such issues. It is
not offered as advice on any particular matter and should not be taken as such. The precedent
documents included in this paper have not been prepared with any particular matter in mind.
Baker & McKenzie, Merck, Thomson Reuters Foundation, the editors and the contributing
authors disclaim all liability to any person in respect of anything done and the consequences
of anything done or permitted to be done or omitted to be done wholly or partly in reliance
upon the whole or part of this paper. Before any action is taken or decision not to act is made,
specific legal advice should be taken in light of the relevant circumstances and no reliance
should be placed on the statements made or documents reproduced in this paper.
TABLE OF CONTENTS
ACKNOWLEDGEMENTS ................................................ III
SELECTED DEFINITIONS ............................................... XI
ACRONYMS ................................................................ XIII
FOREWORD .................................................................. 1
EXECUTIVE SUMMARY .................................................. 3
INTRODUCTION ............................................................ 5
OBJECTIVE ................................................................. 8
BACKGROUND. ............................................................ 8
Technology’s Effects on mHealth Privacy and Security ................... 11
Culture’s Effect on mHealth Privacy and Security. ........................ 12
Law’s Effect on mHealth Privacy and Security ............................ 13
Other Factors Affecting mHealth Privacy and Security ................... 15
Uses of mHealth and the “mHealth Ecosystem”. ......................... 16
METHODOLOGY ...........................................................19