Tag: medical secrecy

Revision of the Swiss Data Protection Act: Conference for HCPs

This Thursday 24 October 2019, I will have the pleasure to present the current state of the revision of the Swiss Federal Data Protection Act (DPA), as currently discussed at the Federal Parliament. I will be discussing the consequences for doctors in private practice in a conference organised by FMH Services, at the Hotel Aquatis in Lausanne.

Since the GDPR become enforceable on May 25, 2018, data protection has become a hot topic and an area concern for many sectors, particularly in the healthcare sector. The various actors, whether healthcare institutions or organizations (HCOs), hospitals, clinics or doctors (HCPs), are particularly sensitive to the changes of the legal framework given the sensitivity of the data processed on a daily basis.

The objective of this conference is to review the updates that will likely pass and be introduced by the total revision of the Swiss Data Protection Act. We will discuss the challenges that doctors will face and the recommendations they will need to receive for preparing to the changes. This will be the opportunity to discuss how the GDPR applies to physicians and HCPs, as well as best practices for the use of technologies by doctors as data controllers of health-related personal data.

The revision of the Swiss DPA aims at strengthening the rights of the individuals, in this case patients, and at aligning on the European data privacy standards. We will examine to what extent the revision fulfils this objective.

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CONSEQUENCES ON THE DAILY PRACTICE OF HCPS

Generally, the daily practice of HCPs will not change drastically with the new Swiss Data Protection Act and the guidance will remain similar for a physician’s practice to the ones already issued by the Commissioner in the past.

In my previous article on outsourcing medical billing, I mentioned what guidance the Federal Commissioner issued in the context of healthcare, which contains exhaustive recommandations, examples and cases studies on security measures at the medical office, outsourcing, guidance on the use of cloud computing and how to respond to patients exercising their access right to medical records. The Federal Commissioner also issued a guidance on how to deal with data privacy generally at the office.

This being said, the major changes for processing of medical information is relating to the use of new technologies, where the risk for medical secrecy and data protection is the highest. This is also true because a very low number of HCPs are prepared to face digital transformation and have little measures in place or best practices for the use of ICTs. This requires an increased vigilance and diligence from health professionals and physicians to avoid being held liable from a civil or a criminal perspective.

Therefore, security and the application of data privacy principles of patient data at the medical office remains essential because of the increased risks associated with the use of information systems, social media, cloud computing, telemedicine and other similar technologies. In this context, all previous recommendations of the Federal Commissioner remain valid (see below) and must be followed, as must those issued by the Code of Ethics of the Swiss Federation of Physicians.

It should be noted that risks increase with the use of telemedicine systems and unsecured means of communication, as well as in the case of outsourcing (subcontracting) of services, such as invoicing or secretarial services.

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FINES IMPOSED ON HOSPITALS AND DOCTORS UNDER THE GDPR

In Europe, we have already seen hospitals sentenced by data protection authorities to administrative penalties of several hundred thousand euros.

Since the implementation of the GDPR, most breaches have consisted of deficiencies in appropriate security measures to protect patient data. Similarly, the violation of the duty to set up controls for the rights of access to the same data in patient files has often been the cause of sanctions and breaches by health institutions.

In this respect, the following European decisions are worth mentioning:

  • Portugal: my previous article and comments on the € 400,000.- fine imposed to a Portuguese hospital. Note that in this article, I also discuss other major fines under the GDPR (equifax, Cambridge Analytica) and the very first fine (ICANN) under the GDPR, as well the situation of Swiss hospitals with regard to privacy and data protection and some elements of the current revision of the Swiss Data Protection Act;
  • Pays-Bas: € 460,000 fine imposed to Haga Hospital (Netherlands) for allowing non-authorized access to employees and third parties to the medical record of a local celebrity. The fine was imposed as a result of inapropriate security measures, especially a weak access control mechanisms (art. 32 GDPR) with no double-factor authentication, which was considered the “ABC” of security;
  • Cyprus: € 14,000 imposed to a doctor for publishing health-related information of a patient on Instagram, mentioning the name of the patient without her consent. After investigations, the Data Protection Commissioner of Cyprus also imposed a €5,000 fine to the hospital for not being able to recover the medical record of the patient following an access request.

These examples demonstrate the importance of privacy and security compliance and data protection principles. Those basic principles have to be applied in medical offices and hospitals. Also to guarantee a good control over personal data, it is crucial to apply the principle of privacy-by-design, implement a complete data protection and management program for all types of health actors.

This should include training, rules of conduct for employees and managers, access controls, as well as appropriate organizational and technical measures to avoid data breaches, unauthorized access to personal data, data losses, alteration, and other violations protection. It also remains key, even for micro enterprise and medical offices to have an action plan in the event of a data breach in order to notify the authorities or the patient if necessary. Given those challenges, a light version of an data protection officer (external) would be welcome.

Even if the legal regime of the Swiss DPA will differ from the European sanctions under the GDPR (2% – 4% of the global turnover or €10 – €20 million), these basic rules and principles are essential and must be respected in order. This is key to avoid civil or criminal liability for violation of the Data Protection Act. Also, where applicable, such behavior may infringe the Criminal Code (Art. 321) for violation of medical secrecy.

Now, the Swiss sanctions system only offers the possibility for individuals to initiate a civiel or a criminal proceedings for violation of the Federal Data Protection Act. The maximum penalties amount to CHF 10k. However, the plan with the revision is to increase the level of criminal fine up to CHF 250,000 maximum. This still remains a criminal fine, based on a criminal trial initiated by a plaintiff or a data subject, where the individual will be held liable, excepting the data controller that cannot receive any direct administrative sanction from the Swiss authority.

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Find my other articles relating to healthcare:

  • Article on the outsourcing of medical data
  • Non-economic physicians and the consequences of overbilling (in French: “polypragmasie”, in German “Überarztung”)
  • Videoconference: software and medical devices regulation
  • Conference on telemedicine

Outsourcing medical billing: a matter of transparency

What is required when outsourcing medical invoices to a third party?

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In healthcare, it is frequent for medical professionals and health institutions to outsource medical billing to a third party. There are many financial and practical advantages to subcontract such service. First, outsourcing can increase efficiency, by reducing the cost of performing these kinds of tasks by the employees. Therefore, it saves work spaces and it is cost-effective, as the service is provided by experts within a company specialized in this area. Second, the responsibility and the costs for investing in this service, the employees’ management, staff training and keeping these skills up to date, are borne by the third party. Finally, one can expect regular reporting services and cooperation from the third party as part of the deal.

Where outsourcing contains many advantages, medical billing must comply with legal obligations, in particular with medical secrecy and data protection regulations, especially if the third party wishes to use the data for another purpose than medical billing. This would be the case if the personal health-related data are used for the supplier’s benefit (such as creating its own creditors and debtors database), or for the benefit of third parties (e.g.: selling the data to insurance companies).

Transferring health data of patients to a third party can infringe medical secrecy and data protection regulations. If the data are not used for the same purpose as for medical invoicing, the Swiss Criminal code (art. 321), the Swiss Federal Data Protection Act (DPA), and cantonal laws protect the medical secrecy by prohibiting undue disclosure without express consent of the patient.

Infringements observed by the Swiss Federal Commissioner

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The Federal Data Protection and Information Commissioner (FDPIC) recently osbserved that third parties specialized in medical billing are using health data of patients to:

  • create their own database with individual’s solvency to categorize them; and
  • sell the data to third parties (such as health insurances).

According the FDPIC, healthcare professionals must reinforce their obligation to comply with transparency, which he states as follows:

“Where healthcare professionals outsource medical billing services to third parties, they shall remain precise and draw attention of the individuals in a clear manner to where and to whom the data would be transferred, and for what purpose the supplier may process such data. This includes in particular using such health-related data to create unrelated databases and potential sales to third parties. In order to comply with this obligation, the healthcare professionals must get the individuals’ express consent“.

Medical secrecy and explicit consent

From a legal perspective, medical personal data – meaning health-related data from an identified or an identifiable individual – are sensitive data. This special category of personal data requires to get the patient’s explicit consent before the processing (art. 4 § 5 DPA), in writing , and before a transfer to a third party for another purpose than for medical invoicing. Therefore, it would be illegal to transfer and use of such data for another purpose without a valid written consent.

This practice complies with both art. 321 of the Swiss Criminal code and art. 10a § 1 let. b of the DPA to the extent the owner of the secret has released the health professional from the medical secrecy.

How do I draft my privacy clause in an outsourcing contract?

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Among the other contract clauses which are specific to the outsourcing agreement, the contract should at least contain the following:

For outsourcing in Switzerland:

  • a reference to the relevant DPA provisions;
  • a warranty from the billing company to comply with the DPA provisions;
  • a warranty of fulfilment of data protection claims of data subjects;
  • the prior consent of the data controller (health professionals) if the data processor decides to subcontract the service;
  • describe the purpose for the processing of the data;
  • an obligation for the employees, auxiliary personnel, freelancers etc. of the processor to comply with the DPA provisions;
  • an obligation for the data processor to comply with data security obligations;

For cross-border transfers to the third party:

  • If permitted by national law to transfer to a third party based in another country, include a provision to regulate cross-border transfers. If personal data are processed (accessed or transferred) in a country without a sufficient protection level for the processing, the data protection clause shall at least include:
    • an obligation to enter into standard contractual clauses, such as the C2P EU model clauses (or privacy shield, or Swiss transborder data flow agreement);
    • an obligation for the data processor to enter into such standard model clauses with its affiliates located in countries without an adequate protection level;
    • an obligation or the data processor to inform the data controller prior the transfer if the data are being subcontracted, including a right to object, and provide information to the controller about the subprocessors (identity, location) and engage the subprocessor with a contract containing the same level of contractual obligations.
  • For the Swiss Federal commissioner, Swiss Doctor should not allow a third party outside Switzerland to access medical records. If so, the Doctor may infringe medical secrecy which is protected by the Swiss Criminal code and by the DPA.

Practical recommendations

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According to the FDPIC, it is not sufficient to inform the patient of such processing somewhere in the medical office, or a waiting room. Nor would it be sufficient to add a clause in small letters in a medical consent form. To comply with transparency, the patient shall receive a proper information to allow – or not – the processing on the basis of a written consent. The patient shall do this without any pressure of any kind.

This short note of the FDPIC reinforces the principle of transparency of the processing.

For the patients

This memo is a call for reinforcement of transparency in the healthcare sector. It explains that more supervision will occur in the future in that particular area to protect the individuals’ right to privacy, and from an undue processing when third parties wish to use the data for their own benefit.

As consent is required, the patient may withdraw its consent at any time. In such event, healthcare professionals and any third party using the data will have to stop using them and potentially delete them to comply with the patient’s request.

For healthcare professionals and hospitals

The principle of transparency, which comes from privacy regulations is not new. It is protected by the non-disclosure obligation for healthcare professionals relating to medical secrecy. But even with the consent to disclose medical information, privacy regulations do not allow anyone to use any personal data for whatever purpose. It would be a breach of the DPA and the processing would become illegal.

In practice, doctors and hospitals shall duly inform the patient to allow him/her to validly consent to sharing medical information for other purposes than for medical billing.

The service provider being a data processor, it has to comply with all the data controller (doctors and healthcare professionals) instructions and requirements, and is responsible for the processing, and to comply with the DPA.

To remain cautious, heathcare professionals should ensure that:

with regard to the service provider:

  • it does not use the data for other purposes than for medical billing;
  • it will comply with privacy regulations, as well as medical secrecy, as the service provider is not bound by medical secrecy;
  • include a paragraph for get the data back at any time, at no costs;
  • for cloud computing purposes, use only service providers based in Switzerland, and draft a contractual clause to prohibit any transfer of such data to a subcontractor or a third party outside Switzerland

with regard to the patient:

  • update the consent forms and add a clear clause – separated from medical related acts – to draw the patient’s attention that the processing may be done for other purposes than medical being (and explain which ones);
  • if the data may be used for other purposes than for medical billing:
    • get the consent after having duly informed the patient and before to process the data; or
    • inform the patient of such transfer in order for the patient to give or withdraw its consent on the processing.

For service providers

The Commissioner has not given its opinion on the supplier’s civil responsibility towards the patient for undue processing, or medical secrecy infringement, or both.

In order to protect the service provider for using the data for other purposes than medical billing, it may perform the following:

  • anonymize the data, whichever it will use the data for its own use or to sell the data to third parties. In this case, medical secrecy and privacy laws will not apply;
  • clarify with healthcare professionals for what other purposes it wishes to use the data;
  • request healthcare professionals to ensure, in the outsourcing agreement, that the patient has been informed of the processing validly given its consent to the processing;
  • include a specific exclusion of liability in case of a third party claim (for medical secrecy of privacy infringement);
  • add an indemnification clause for losses it may incur as a result of the breach of privacy laws or medical secrecy.

To go further, see the following notes on the website of the Swiss Federal Commissioner:

  • This note in French, German or Italian on outsourcing in the context of healthcare
  • This note in French, German or Italian on the use of service providers for keeping medical records in the cloud
  • This note in French, German or Italian on security in medical offices
  • Guide on processing of personal data in the context of healthcare

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Gabriel Avigdor | NTIC.ch