Thank you. This is an excellent summary report with important implications for data safety and patient privacy in m-Health initiatives as well as mobile-based money transfer systems such as M-Pesa in Kenya. An important question will be how to sustain one phone number per person/family in low resource settings where numbers change frequently. This will be essential for privacy, continuity of care, and sustainability of initiatives. As recommended by Ngugi, Ogembo , & Pelowski (2010), associating value (such as m-based money) with a specific phone number may increase the value and retention of one cell number.

Lisa:

mHEALTH PRIVACY AND SECURITY ISSUES

There are many challenges here, and I will focus only briefly on the technology and international collaboration issues, which I regard as two of the most critical issues that need addressing and resolution before mHealth can advanced safely and maturely. Given that mHealth data are collected everywhere, in contrast to convention healthcare data that was largely within HCO facilities, and BY everyone (thus no longer restricted to HIPAA-compliant HCOs), so that the "reach of HIPAA constraints are likely to be significantly insufficient, a viable mHealth Privacy/Security (mHealth-PS)Framework will require:

(1) Enabling cross-border transactions as well as cross-border translations, between divergent payment and/or encryption schemes.

(2) International integration, preferably under auspices of an international collaborative central authority to avoid national, regional and sectarian balkanization. And although a global consensus governing all facets of mHealth privacy and security would be unrealistic, a Minimal Common Framework (MCF) for mHealth Privacy should be securable. This would serve to integrate core features the EU's Consultation on the mHealth Green Paper [1] when they are delivered after 2nd of July 2014 (and in compliance with Article 8 of the Charter of Fundamental Rights of the European Union, as well as in Article 16(1) of the Treaty on the Functioning of the European Union (TFEU), and the Personal Data Protection Directive [2]). These in turn must be integrated with the WHO-ITU Joint Agreement on mHealth for Non-communicable Diseases (NCDs) as outlined in the WHO report "mHealth - New Horizons for Health through Mobile Technologies" (2011) [3,4], and with the EU-US Memorandum of Understanding (MoU) on eHealth/Health IT [5], as well as with the emerging SHARPS (Strategic Healthcare IT Advanced Research Projects on Security) [6] under the auspices of the U.S. Office of the National Coordinator for Health Information Technology (ONC) (within the U.S. Department of Health and Human Services (HHS)), among others with cross-border dimensionality.

(3) Articulation of viable Patient Notice and Consent (PNC) requirements.

(4) Identification authentication assurance via PKI-based (Public Key Infrastructure) technologies or equivalents.

(5) In-flight dynamic security/privacy safeguards that may include at minimum E3 (end-to-end encryption), or more sophisticated deployment of tunneled VPNs (Virtual Private Networks).

(6) Data store security and access protection with full auditing and NTK (Need-To-Know) safeguards.

(7) Data segmentation technologies: to assure that only the minimal and most justifiable data be accessed and transmitted (providers needing immunization data should not also have access to mental health data), implementing therefore, rights at the minimal data segment, not database, level.

(8) De-identification technologies to assure "data scrubbing" transformation to limit determination of whether given data is associated with a given individual.

Among of course many other regulatory, legislative, cross-border and technological issues.

Many of the regulatory issues are discussed more fully elsewhere [7] and some key enabling mHealth privacy and security technologies are highlighted in the many Round Table Presentations on Investigating Privacy and Security Challenges of mHealth Applications [8], given at recent 19th Americas Conference on Information Systems (AMCIS) Conference, but the above may serve as a brief launching platform for further deliberation.

REFERENCES

1. Green Paper on Mobile Health ("mHealth"). Policy/Legislation. Digital Agenda for Europe. European Commission. Brussels, 10.4.2014. At: http://ec.europa.eu/digital-agenda/en/news/green-paper-mobile-health-mhealth.

2. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281/31, 23.11.1995.

3. WHO-ITU Joint Agreement on mHealth for Non-communicable Diseases (NCDs). World Health Organization (WHO) jointly with United Nations International Telecommunication Union (ITU). At: http://www.itu.int/en/ITU-D/ICT-Applications/Documents/mHealth_for_NCDs_June2013.pdf; also: http://www.who.int/nmh/events/2012/mhealth_background.pdf.

4. mHealth - New Horizons for Health through Mobile Technologies. World Health Organization (WHO). 2011. http://www.who.int/goe/publications/goe_mhealth_web.pdf.

5. Memorandum of Understanding Between the United States Department Of Health And Human Services And the European Commission On Cooperation Surrounding Health Related Information and Communication Technologies. 2010. At: http://www.healthit.gov/sites/default/files/mou-onc-hrsa-usda_2011.pdf.

6. Strategic Healthcare IT Advanced Research Projects on Security (SHARPS. U.S. Office of the National Coordinator for Health Information Technology (ONC). U.S. Department of Health and Human Services (HHS). At: http://sharps.org/.

7. Patient Privacy in a Mobile World: A Framework To Address Privacy Law Issues In Mobile Health. mHealth Alliance. June 2013. At: http://www.mhealthalliance.org/images/content/trustlaw_connect_report.pdf.

8. Investigating Privacy and Security Challenges of mHealth Applications. Round Table Presentations. 19th Americas Conference on Information Systems (AMCIS) Conference. Chicago, 2013. At: http://aisel.aisnet.org/amcis2013/HealthInformation/RoundTablePresentations/6/.

The security required for any settings will be based on a security analysis of:

a) The level of security that is required for the information and the system implemented(usually by legal requirements. Note: in multiple jurisdiction scenarios apply the most stringent requirement for the whole system)

b) The expected threat (internal vs external,etc.)

c) the opportunities of the threat to take advantage of a vulnerability to exploit a system

The expected security solution will be based on making a possible attack ona system expensive enough so that it it is not profitable to the attacker.

Your security issues in a general scenario that you described will be divided into:

1) Privacy and integrity during transmission

2) Privacy and integrity during storage

3)Availability, integrity and privacy in disclosing findings.

4) Disposing of the data once the study is concluded

With respect to (1) you can instruct persons involved to use anonymity proxies or you can assume that the receiver is a trusted entity(this will depend on the risk assessment for a particular scenario). The usual scenario is that the receiving party is a trusted entity that has the need to know and associate the source to the information.The communications medium can be secured through the use of encryption of the communications channel used. This requirement will limit the availability of mediums used to collect the data since some of them do not use encryption and securing each particular means of gathering information can be costly to analyze and implement. The integrity of the communications channel can be addressed by hashing algorithms.

The security in (2) will depend on whether the people used to manage the application are trusted entities or not(again determined by a risk assessment). The design of the required solution may focus on: access of personnel (least privilege to carry out their required work) proper maintenance of the system(patches, etc) and encryption of the information.

For information disclosure the need to implement Data anonymization schemes is very important. One point to have here is that the anonymization scheme selected should be resistant to inferential attacks.

The final point which is one that I find most people forget is to use proper disposal techniques after the study has finished. It is worthless to implement all the above security measures if you forget to properly dispose of the data and the system is then reused in another project without sanitizing the system first.

A final thought is that all security measures in a project such as mobile health will depend on the minimum technology requirement accepted into the project. If resources are constrained it may be necessary to accept technology that is not secure and this will weaken the proposed system.

Hope this helps

There are a good number of conceptual frameworks developed for the purpose. An excellent survey of them can be found here.

http://www.cs.dartmouth.edu/~dfk/papers/avancha-survey.pdf

Thank you for these answers and references; all immensely helpful.

Another related question: what are the legal and ethical implications for European and American privacy laws in regards to health-related information when conducting mHealth research in Sub-Saharan Africa?

Relying on the government to protect your privacy is like asking a peeping tom to install your window blinds (John Perry Barlow)

I think total confidentiality will come about when finger print technology is perfected on smart phones.Such information would be encrypted and accessible only to the person bearing that unique identity.

For now, access to phone ,access to passwords, unencrypted text might compromise data!!

The issue of privacy or confidentiality is very critical at all times and it should always be give first priority to the individuals or groups involved. To begin with, all privacy issues should be initially addressed using a specific and comprehensive policy on the subject. One of the key issues is to identify/define confidentiality factors (variables). Use a participatory method. The policy elements should be anticipatorily developed and they should take into account, all the key privacy issues of socio-cultural, economic (e.g. financial), environmental (e.g. sanitation), political, and legal issues. For example, the use of special passwords, codes, tones, or sounds). Lack of privacy or confidentiality has very serious consequences on individuals, families, communities, groups, or nations; if unchecked or ignored with impunity. Privacy and confidentiality vary with culture, perception, level of knowledge, age, gender (sex), (social, economic, or political) status, roles, profession, duties, and responsibilities.