France face tracks draft law to create national health database

1. INTHISISSUEINTHISISSUE
Texas telehealth
rule prompts
‘restriction’ fears
BSI publish code of practice
for health app development
France fast tracks draft law to
create national health database
The British Standards
Institution (BSI) published on
30 April a new code of practice
for healthcare app develop-
ment, which aims to provide a
set of principles for developers
in order to build trust amongst
healthcare professionals,
patients and the public in their
products and services.
The publically available speci-
fication ‘PAS 277:2015 Health
and wellness apps - Quality
criteria across the life cycle -
Code of practice’ developed in
conjunction with Innovate UK
will,according to the BSI’s press
release, enable app developers
to come up with innovative
ways of providing solutions
that can be adopted by health-
care professionals and the
public, and will help support a
change in how healthcare is
delivered.
PAS 277 provides recommen-
dations for quality criteria for
health and wellness apps;covers
the full app project lifecycle,
including development,testing,
releasing and updating; and
informs the development of
health and wellness apps
intended for internal use as
well as those placed in the
market. Bleddyn Rees, Partner
atWragge Lawrence Graham &
Co, thinks that PAS 277 is
important for compliance. “If
developers comply with this
[new code of practice] apps will
be substantially more reliable,”
explains Rees.
The UK’s Royal College of
Physicians (RCP) published
guidance on 29April in consul-
tation with the Medicines and
Healthcare Products Regulatory
Agency and the General
Medical Council on the use of
medical apps by doctors,which
inter alia states that doctors
should only use medical apps
that have a CE mark and should
always exercise professional
judgment before relying on
information from an app.
Lincoln Tsang, Partner at
Arnold & Porter, explains that
the requirement that doctors
only use medical apps with a CE
mark means in simple terms
that medical apps must be
regulated and subject to a
process called conformity
assessment to ensure that they
are designed and manufactured
in such a way that when used
under the conditions and for
the purposes intended they will
not compromise patient safety.
“The RCP’s guidance will
bring greater awareness
amongst healthcare profession-
als about the regulatory
landscape for CE marked
medical apps,” adds Tsang. “It
sets out the best practice to
ensure that physicians use a
properly regulated app in the
interest of patient safety.”
The French National Assembly
adopted draft legislation on 14
April, which would create a
national health database in
France. According to the
proposals, health data from
multiple sources would be
aggregated in a National System
of Health Information (SNDS).
“The French National Health
Insurance Fund would play a
key role in the management of
the SNDS to regroup (i) data
derived from hospital informa-
tion systems, (ii) data derived
from national health insurance
information systems, (iii) data
on the causes of death, and (iv)
part of the data related to the
reimbursement of medical
products provided by comple-
mentary private health insur-
ance companies,” said Daniel
Kadar, Partner at Reed Smith.
The French data protection
authority (CNIL) will be
involved in defining the
anonymisation procedures that
will result in anonymised files
being made available to
everyone. Datasets containing
some personal data will also be
aggregated, but access to those
datasets will be restricted and
subject to the authorisation of
the CNIL. “In the case of the
SNDS, the draft legislation
provides no measure of security
and will be available to public
authorities. This represents the
biggest privacy risk,”adds Pierre
Desmarais,Founding Lawyer at
Desmarais Avocats.
The draft is being examined
under the accelerated proce-
dure, which could see the act
adopted after the first reading
before the French National
Assembly and the French
Senate if consensus on the final
wording of the text is reached.
The Texas Medical Board voted
on 10 April to introduce a new
rule on the practice of telemed-
icine in the state, which would
mean that a doctor-patient
relationship, necessary under
state law for treatment to be
given, cannot be established by
‘questions and answers
exchanged through email,
electronic text, or chat or
telephonic evaluation of or
consultation with a patient.’
“The new rule is perceived as
restrictive by some and clarify-
ing by others,” said Julian
Rivera, Partner at Husch
Blackwell LLP. “The difference
in perspective generally
depends on the current and
planned care models of the
perceiver.”Rene Quashie,Senior
Counsel at Epstein Becker
Green, believes however that
“the rule is overly restrictive,
and will certainly prevent many
innovative telemedicine
delivery models from being
implemented in Texas.”
The new rule is set to enter
into force on 3 June 2015;
however,telemedicine provider
Teladoc has filled a complaint
for a preliminary injunction in
a Texas District Court to block
the rule, arguing that the rule
‘would dramatically restrict
competition from telehealth.’
mHealth Pharma apps
and EU regulation 03
Health IT Information
blocking in the US 06
Clinical Trials New
Portuguese draft law 08
Health IT An overview
of HIMSS 2015 10
Cyber Security Health
data in the US 12
Turkey Government’s
E-Pulse Project 15
The monthly journal for the connected health industry
VOLUME 02 ISSUE 05 MAY 2015 WWW.E-COMLAW.COM