Managing e-health data:
Security management in practice
Marc Nyssen
Medical Informatics VUB
Master in Health Telematics KIST E-mail: [email protected]
Structure of the presentation
Practical approach towards ISMS: plan, do, act, check
How to start
Scope of the “institution”
People and committees concerned
Documents
Practical approach: plan
1- Determine the scope (department, application, institution?) (step 1)
2- Determine the information/privacy policy (step 2)
3- Comprehensive risk analysis (steps 3, 4, 5)
4- Plan risk treatment (step 6)
5- Select management goals and controls (step 7)
6- Prepare statement of applicability (step 8)
Practical approach: Do
1- Perform risk treatment, with resources allocated and controls
(steps 1, 2, 3)
2- Educating and training (step 4)
3- Manage operations and business resources (steps 5, 6)
4- Deal with security incidents (step 7)
Practical approach: Act
1- Carry out improvement measures (step 1)
Practical approach: Check
1- Monitor procedures and controls (step 1)
2- Review ISMS regularly (step 2)
Plan: 1. Scope of the “institution”
Delimit the boundaries of data security management”
–
Department
–
Hospital
–
Single application: for example “medical record system”
–
Including or not including physical access
Plan: 2. Determine the information
security/privacy policy
Information/privacy policy of the institution:
Organizations processing health information, including personal health information, shall have a written
information security policy that is approved by management, published, and then communicated to all employees and relevant external parties.
General policy statements concerning how data is managed by the institution PLUS:
a) the need for health information security;
b) the goals of health information security;
c) compliance scope
d) legislative, regulatory, and contractual requirements, including those for the protection of personal health information and the legal and ethical responsibilities of health professionals to protect this information;
e) arrangements for notification of information security incidents, including a channel for raising concerns regarding confidentiality, without fear of blame or recrimination.
f) the breadth of health information;
g) the rights and ethical responsibilities of staff, as agreed in law, and as accepted by members of professional bodies;
Plan: 2. Determine the information
security/privacy policy
h) the rights of subjects of care, where applicable, to privacy and to access to their records;
i) the obligations of clinicians with respect to obtaining informational consent from subjects of care and maintaining the confidentiality of personal health information;
j) the legitimate needs of clinicians and health organizations to be able to overcome normal security protocols when healthcare priorities, often linked to the incapacity of certain subjects of care to express their preferences, necessitate such overrides; also the procedures to be employed to achieve this;
k) the obligations of the respective health organizations, and of subjects of care, where healthcare is delivered on a “shared care” or “extended care” basis;
l) the protocols and procedures to be applied to the sharing of information for the purpose of research and clinical trials
m) the arrangements for, and authority limits of, temporary staff, such as locums, students and “on-call” staff;
n) the arrangements for, and limitations placed upon, access to personal health information by volunteers and support staff such as clergy and charity personnel.