Patient consent vital for new healthcare models

The rules and regulations encompassing the healthcare industry are changing; are you getting the most out of your data?

In this new and evolving data consent landscape, new legislations are being introduced and privacy regulations are being enacted worldwide: It’s vital to keep abreast of which laws are being implemented but also what technologies leading players in the pharma, life sciences and healthcare industries are using to ensure auditable compliance and improve patient trust.

Innovative technologies such as Wearable Tech can now provide patients (and their physicians, if permitted) with round-the-clock monitoring, from tracking their sleep patterns to accurate ECG readings.
Having access to this calibre of data will redefine the notion of patient care, from being able to digitally monitor whether a patient is taking their prescription to guaranteeing a new level of personalised treatment – based on a patient’s diagnosis but also their specific genetic makeup.

For patients, these advancements mean medical professionals can diagnose and treat conditions faster and with better patient outcomes than ever before. For government healthcare organizations, this will dramatically reduce the amount of time and resources spent on fruitless tests and unwarranted prescriptions.  

Patient expectations – and even their behaviours – will change, as citizens evolve a nuanced and informed understanding of consent and take greater interest than ever before in who can access their data, and the purposes for which that is used as well as the personal benefit to them. As healthcare businesses increasingly deliver through collaboration, they need to redefine their positioning with regards to value to the healthcare system and patient outcomes. 

In fact, healthcare organizations such as pharmaceutical companies and medical insurance companies must comply with a plethora of rules and regulations to ensure the protection of patients’ medical records against data misuse, exploitation, and discriminatory practices.

Healthcare organizations are well aware (or should be) that any noncompliance to data privacy legislations such as HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation) will lead to fines and even significant criminal charges.

Attempted violations of HIPAA attract penalties up to $50,000. In contrast, the GDPR fines (Article 83) are bifurcated; less severe infringements attract fines of up to €10 million, or 2% of the firm’s worldwide annual revenue from the preceding financial year, whichever amount is higher. More serious infringements attract fines of up to €20 million, or 4% of the firm’s worldwide annual revenue from the preceding financial year, whichever amount is higher.

This article will both outline the major challenges facing healthcare organizations and how to address them.

What are the risks of not managing health data correctly?

When it comes to the health sector, data accidentally posted, leaked, emailed to the incorrect recipient or even faxed can translate to ‘’minor’’ clerical errors such as patients being unable or ineligible to update their medical insurance.

On the other end of the spectrum, data mismanagement could lead to life-threating consequences such as compromised health or even death.  

As medicine becomes an increasingly data-driven operation, companies need to consider: 

• The quality of the data they hold, in terms of accuracy, granularity, recency. 

• The format of the data they hold, to support machine learning and other data science techniques which will deliver better outcomes. 
• How to build patient, professional and distribution chain trust: because without consent, a company’s ability to thrive will be severely capped. 

It is in this vital last area: the building of trust through transparent, patient-controlled consent interfaces that Cassie from Syrenis delivers. We help large healthcare companies go beyond compliance, meeting new expectations around how patient data is treated and deliver on what today’s citizens expects: powerful benefits for sharing their precious data, complete control and complete transparency. 

What data privacy obstacles do healthcare organizations face and how can they tackle them?

Healthcare organizations face a slew of data privacy challenges. Let’s identify the key privacy challenges for managing healthcare data privacy and the measures organizations can take to address them

• Information segregation and assessment  

A healthcare organization receives data in fragments and different formats from multiple sources. Segregation of personally identifiable information (PII) from fragmented data coupled with regularly changing requirements for data, governance, and privacy compliance, poses a great challenge to privacy teams.

To comply with an ever-increasingly complex patchwork of regulations, health data organizations must increase their visibility into data under their control and define relevant context around purpose and consent. 

Healthcare organizations need to implement matching and grouping rulesets within their data platform, which can be configured by clients to determine how incoming data will be sorted and processed.
These rulesets will effectively sort incoming data to ensure that it’s attributed to the correct data subject, and will flag any potential issues such as record duplication, incorrect identifying information etc. 

These rulesets can be as complex or as simple as required. They are used to handle a number of complex use-cases, from persona-driven consents to managing siloed data structures, where data subjects exist simultaneously in many systems, with different identifiers. 

• A demand for privacy officers 

An increasing number of regulations worldwide mandate that organizations employ a privacy expert. 

The success of privacy officers can be measured by their ability to implement a preparatory plan in order to identify and prioritize company actions. This analysis will provide clear insights regarding risk-mitigating measures and effectiveness. 

What following steps will privacy officers need to take?

First and foremost, privacy officers will need to establish transparency in their privacy management programs by installing and maintaining privacy documentation for business units and users internally, and focusing on the privacy User experience (UX) externally because the privacy UX is a key driver of maximising consent: where UX instills confidence and trust in patients, consent is more likely to be given and renewed. 

Secondly, they must establish a structured privacy risk discovery and management program by reviewing existing personal data processing operations, using metrics to prioritize major privacy risks

• Territorial scope of privacy regulations 

Cross-border transfer of health data is a major concern for health organizations that need to transfer data from one nation to another for research purposes.
The statutory conflict between multiple legislations affects the transfer of data to foreign institutions. For certain data subjects, it is difficult to exercise their rights if the processing of their data takes place outside the country of origin.
 

For data being processed or intended to be processed post-transfer to a third country, GDPR mandates data controllers or processors to meet the conditions mentioned in Chapter V, Article 44. Article 45 lays the requirements for an adequacy decision by the European Commission, which decides whether a non-EU country ensures an adequate level of protection. In its absence, adequate safeguards put in place (Article 46) and explicit consent (Article 49) provided by the data subject, make the transfer possible.

Healthcare organizations not only have a moral, but a legal responsibility to stay updated and go beyond compliance, to elevate privacy in healthcare as expected by patients.

Technology and the application of data science offer powerful opportunities to enhance the quality of life for all citizens. This use of increased patient data, and the sharing of increased volumes, variety and velocity of patient data with healthcare professionals as well as the use of this data in trials however, can only be achieved through patient consent, which relies on trust. Adopting the right Consent and Preference Management Solution is essential if healthcare companies are to achieve this.

What is Cassie and how can it help?

Consent matters now more than ever. Cassie by Syrenis is a consent management platform that helps organizations use privacy as a differentiator, by building trust and using customers’ own declared preferences to improve their consent journey.