See Data Protection Act 1998, Schedule 1 Parts I and II.
See generally Clerk & Lindsell on Torts, London: Sweet
& Maxwell 18th edn. The French word for ‘tort’
literally means ‘wrong.’
See Health Insurance Portability and Accountability
Act of 1996 (HIPAA).
See Part II of Data Protection Act 1998 generally.
See Pub. L. 104-191; 42 USC Section1320d-5; Pub. L.
104-191; 42 USC Section 1320d-6. A person who
knowingly obtains or discloses individually identifi-
able health information in violation of HIPAA faces
a fine of $50 000 and up to one-year imprisonment.
The criminal penalties increase to $100 000 and up
to 5 years imprisonment if the wrongful conduct
involves false pretences, and to $250 000 and up to
10’years imprisonment if the wrongful conduct
involves the intent to sell, transfer or use individually
identifiable health information for commercial
advantage, personal gain or malicious harm. Crim-
inal sanctions will be enforced by the Department of
Justice.
See Schedule 17 of Act for notification requirement.
See, for example, Community Code 2001/83/EC and
amending Directives 2003/63/EC (implemented in
the UK by SI 2003/2321) and 2004/27/EC (imple-
mented in the UK by SI 2004/3224).
See, generally, Andrew E. Costa, ‘‘Negligence per se
Theories in Pharmaceutical & Medical Device Liti-
gation,’’ 57 MELR 51 (2005).
The advisory role of the CHMP in the EU is similar to
the advisory role of the Committee on the Safety of
Medicines in the UK.
The Consumer Protection Act (1987) Schecdule
4(1)(e).
The new Reg. 726/2004 now makes the authorisation
procedure compulsory for orphan medicinal pro-
ducts and medical products for human use contain-
ing an entirely new active substance for the
treatment of AIDS, cancer, neurodegenerative dis-
order or diabetes. See Annex to Regulation listing all
products now requiring Community authorisation
and those needing it as of 2008.
This is a simplification of a complex area of law for the
purposes of this introduction. These themes are
explained more fully in subsequent chapters.
With thanks to N. Leverett in Shook, Hardy and Bacon
LLP Houston and E. Bolton Shook, Hardy and
Bacon International LLP, London.REFERENCES 603