Legal Issues in E-Healthcare Systems - E-Healthcare Systems and Wireless Communications - page 31

It is to be noted that the above mentioned
circumstances should only be used to the benefit
of the data subject rather than to a third country
data user. As per the directive a data user who has
obtained personal data from any source and uses
the personal data for direct marketing purposes
shall cease to use it after the appointed date or if
the data subject is so requested. The EU Direc-
tive provides considerable level of protection for
personal data. The drawback of this Directive and
the Clinical Trials Directives 2001/20/EC is that
they are going to impinge upon the health research
and public health monitoring. However, if the
relevant organisations use anonymised data, there
is no requirement of getting consent. The level of
protection given to EU citizens is not available
in many countries. In USA Health Insurance and
Accountability Act (HIPAA) 1996 addresses the
issue of medical privacy. It is intended to protect the
confidentiality of patients' health data. It requires
the health services providers to enforce specific
safeguard and consent procedures. Patients' right
to access to their medical data to ensure accuracy
of data is ensured under this legislation. It also em-
phasises getting patients' consent before sharing
information for treatment, payment and health care
operation. Separate authorisation from patients is
necessary for non-health care purposes. However,
in case of emergency the requirement could be
waived. In Singapore, Electronic Medical Record
Xchange (EMRX) was initiated by Health Ministry
of Singapore to allow sharing of medical informa-
tion. To protect privacy and security of medical
data, doctors need National Registration Identity
Card Number of the patients. However patient has
no explicit right to control and dissemination of
information about himself. The Ministry has less
control over private hospitals and self regulation
could be ineffective. The government is going
to introduce password and smartcard system to
prevent theft and other related breaches. However,
appropriate amendment to the laws is necessary
to allow patients to control the dissemination of
their information (Tsai, 2010). Malaysia has been

since 1998 endeavouring to pass a legislation that
could provide adequate protection for privacy,
but due to pressure from the industries it has not
come to pass yet. Due to these variations in the
privacy legislation many users are sceptical about
the real use of the systems.

Product Liability

The e-healthcare system requires a continuous
supply of products and services to various par-
ties across boundaries using multiple suppliers or
service providers. In the process there are concern
as to validity of contract and the consequences
and liability of parties in the breach of contract.
In addition to contractual liability the tort liability
of manufactures, suppliers and service providers
are also important legal issues that need to be
addressed, and this part will analyse the follow-
ing issues: When an e-contract is formed? Does
the law of sale of consumer goods and services
apply to e-health product and services? How
will the consumers and the professional users be
protected? What are the liabilities of the e-health
service providers? Does the ISP have any duties?
Which country's law would be applicable and
which country's court will decide the case. What
are the liabilities in negligence?

Electronic Contract

“Electronic contracts” may be said as legally
enforceable promises or set of promises that are
concluded using electronic medium (L. Kidd, &
Daughtery, 2000). The UNICITRAL Model Law
on Electronic Commerce, in Article 11, instead
of defining an electronic contract, merely states
that a contract can be made by exchanging data
messages and when a data massage is used in the
formation of contract, the validity of such contract
should not be denied. However, the Article 2B of
the US Uniform Commercial Code which was later
incorporated into the Uniform Computer Informa-
tion Transaction Act 1999 states that an electronic