Pharmacy Data Law (2009:367)

Original Language Title: Apoteksdatalag (2009:367)

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2009:367

Introductory provision



section 1 of this Act apply to such processing of personal data

at öppenvårdsapotekens retail of medicines etc. which

is completely or partially automated, or where the data

form part of a filing system or are intended to form part of a structured collection

of personal data, are available for searching or

compilation according to specific criteria.



Personal data relating to consumers and the competent

to order products may be processed for the purposes specified

in section 8.



Relationship to other laws



2 §/expires U: 2016-01-01/

In this law, terms and concepts that are also present in

the medicines Act (1992:859) has the same meaning as in the Act.



It as in this Act provided, in the case of medicinal products should also

apply such products and groups of products referred to in paragraph 3 of the

the medicines Act.



2 section/entry into force: 01/01/2016

In this law, terms and expressions that are also present in the medicines Act (2015:315) has the same meaning as in the Act.



It as in this Act provided, in the case of medicinal products shall also apply to such goods and product groups as referred to in chapter 18. section 2 of the medicines Act. Law (2015:324).



Definitions



section 3 With community pharmacies as referred to in this law such

establishment for the retail sale of medicinal products is carried out with

authorisation pursuant to Chapter 2. section 1 of the Act (2009:366) on trade in

medicines.



With the authorization referred to in this law as referred to in Chapter 2.

paragraph 1 of the law on trade in drugs has been authorised to

retail sale of pharmaceutical products.



Requirements for processing, handling and storage



section 4 of the personal data to be processed so that the individual's

Privacy is respected.



Documented personal information shall be handled and stored so

that unauthorized persons do not have access to them.



Relative to the personal data Act



paragraph 5 of the personal data Act (1998:204) applies to

öppenvårdsapotekens treatment of personal data, unless

subject to the provisions of this Act or the regulations issued in

connection to this law.



The individual's attitude to personal data treatment



section 6 of the processing of personal data is permitted under the

This Act may be carried out even if the individual disagrees with the

the treatment.



The processing of personal data which is not permitted under the

This law must nevertheless be carried out, if the individual has provided a

explicit consent to the processing.



Privacy responsibility



paragraph 7 of the licence holder is responsible for the

personal data processing that is performed on an outpatient pharmacy.



Purpose of the processing of personal data



paragraph 8 of the personal data may be processed if necessary for



1. dispensing of medicinal products ordered, and ordered

goods covered by the Act (2002:160) on pharmaceutical benefits

accommodation as well as for measures relating to the processing,



2. disclosure of information to the E-hälsomyndigheten under 2

Cape. 6 § 5 or 7 teams (2009:366) on trade in

medicines,



3. handling of complaints and recalls,



4. Administration of part payment of medicines and products

covered by the law on pharmaceutical benefits, etc.,



5. Administration of full powers to pick up medicines,



6. disclosure of information to the Inspectorate for health and

care, and national agency for their supervision;



7. reporting to prescribers on the exchange of drugs

According to the fourth paragraph of section 21 of the law on pharmaceutical benefits

accommodation,



8. health-related customer service,



9. to disclose the recipe or form to

the consumer,



10. systematic and continuous development and enforcement

of öppenvårdsapotekens quality, and



11. administration, planning, monitoring and evaluation of

öppenvårdsapotekens activity and the production of

stats.



Such processing of personal data referred to in the first subparagraph 5

and 8 may not extend to anyone other than those who have left their

consent to the treatment.



For the purposes referred to in the first subparagraph 10 and 11 may no

data are presented that can be attributed to a single

person. Team (2013:1027).



Processing of personal data for other purposes



section 9 in respect of the processing of personal data for other

purpose than that described in paragraph 8 of the terms of paragraph 9 (d)

and the second subparagraph personal data Act (1998:204).



Search terms



10 § Identity may be used as a search term only in the case of



1. consumer, for the purposes set out in section 8, first subparagraph

1, 3 to 5, 8 and 9, and



2. a person who is authorized to order medicines, for the purposes

referred to in paragraph 6 and 7.



Prescribing the cause may not be used as a search term.



Disclosure on medium for automated processing



section 11, a personal task, may it be on medium

for automated processing.



Permission assignment



section 12 of the licensee shall determine the conditions for allocating

of permissions for access to partially or completely automatically

processed data about consumers and the competent

to order medicines. This privilege is restricted to what

needed to the working in an outpatient pharmacy

to fulfil their duties there.



The Government, or Government authority determines,

provide for the assignment of permissions for access

to partially or completely automatically processed data.



Access control



section 13, the licensee shall ensure that access to

or partly automatically processed data about consumers

and those who are competent to order medicine, documented

so that they can be controlled. The licensee shall

systematic and periodic check if any unauthorized

access to such data.



The Government, or Government authority determines,

provide for documentation and control.



Conservation



section 14 When personal data is no longer needed for treatment

According to the purposes of section 8, the task is removed.



Rectification and indemnity



section 15 of the provisions of the personal data Act (1998:204) about

rectification and Indemnity apply to the processing of

personal information under this Act.



Information



section 16 of the licence holder shall ensure that the individual receives

information on personal data processing.



That information shall include information on



1. who is the data controller,



2. the purposes of the processing,



3. the obligation which may result from legislative or

Regulation,



4. confidentiality and security provisions that apply

for information and treatment,



5. the right to take part of the information referred to in section 26

personal data Act (1998:204),



6. the right under section 15 of the correction of inaccurate or

misrepresentations,



7. the right referred to in section 15 to damages in the treatment of

personal information in contravention of this Act;



8. what applies in the case of search terms,



9. what applies in terms of retention, as well as



10. whether the personal data treatment is voluntary or

do not.