Compliance

Compliance Ethically Managing Medical Information

By BRUCE JENNINGS

Watching Our Health

Information is power, perhaps more so today than in the past. Should we be alarmed because someone is watching us, or comforted because someone is watching over us? Confidentiality is about your ability to control who has access to information about you and how it is used.

PROTECT YOUR DATA

It is not surprising that in many countries legal steps have been taken in the last decade to protect the rights of individuals and the confidentiality of health information, and regulations affecting the workplace figure prominently in this. In 2007 the EU issued a report setting out a strong framework of safeguards regulating the use of electronic medical records. The US also has several national laws that relate to discrimination against the disabled (the Americans with Disabilities Act of 1990), the handling of medical records (the Health Care Information and Patient Protection Act of 1995; the Health Information Technology for Economic and Clinical Health Act of 2009), and genetic information (the Genetic Information Nondiscrimination Act of 2008).

SPECIAL PROTECTION FOR DISABILITIES

The approach in both Europe and the US has been to impose duties and liabilities on health professionals and organizations rather than on employers. And here the key rule is the requirement of patient informed consent. However, medical conditions that are considered disabilities and genetic conditions are given special protections not only in the clinic but also in the workplace. Such conditions may not be taken into consideration in hiring decisions. For ongoing employment, when companies collect and maintain employee health information for insurance or other HR programs, steps (such as restricted access) must be taken to ensure that such information will not adversely affect the supervision, evaluation, and opportunities of the employee.

NEW PARADIGMS

In the workplace emerging today, greater confidentiality in the handling of health information is a part of a whole new paradigm in the relationship between employers and employees. Chronic health impairments do not necessarily negate skill, experience, and productivity. Disabilities should no longer be a basis for simply excluding of the individual from normal employment; instead, workplace accommodations should be made to mitigate that individual’s special needs. Employee health challenges should be creatively overcome, not stigmatized. This new attitude makes good ethical and business sense.•

How Do Companies Handle Employee Health Data in a Genome-Free Access Society?

By ELAINE ZACHARAKIS LOUMBAS With the explosion of technological advances in the mapping of the human genome, our DNA is not just the code for

identifying us and giving us our known hereditary traits, but the predictor for our predisposition to a number of health conditions and perhaps even

behaviors. Having an employer access such information would make many very uncomfortable. To address these growing privacy concerns, in 2008, the United States Congress passed the Genetic Information Non-Disclosure Act (“GINA”). GINA makes it “an unlawful employment practice for an employer to request, require or purchase genetic information with respect to an employee or family member.” There are exceptions to this general rule. One important exception is where “the employee provides prior, knowing, voluntary and written authorization.” Why would anyone freely give such an authorization to his or her employer?

By MARGARET CURNUTTE

Behind the Genetic Veil of Ignorance

Imagine that you know nothing about your abilities, tastes, gender or social position. You don’t know what benefits and burdens you will confront in life. Indulge this thought experiment a bit more and ask yourself—if you were able to design a society from the ground up—what kinds of social arrangements would you want?

Twentieth century American philosopher, John Rawls, challenged us to assume this “original position” in his seminal work A Theory of Justice. He asked us to place ourselves behind “the veil of ignorance” and to imagine not knowing what your lot in life would be. Up until the second half of the twentieth century, we have for the most part, not needed to place ourselves behind a veil of ignorance when considering our genetic fates. When Rawls published this work in 1971 it would not have made sense to add, for example, one’s genetic disposition for developing breast cancer to the list of things that should be placed behind the veil. We did not know of any genetic mutations that corresponded to the disease. We were fairly ignorant about the genetic dimensions of our lives. Today, in the era of personal genomics, we have new tools at hand to both probe our selves and try to manage the uncertainty of disease. With such technological change comes the expansion of ethical and political negotiations about how we ought to live. Genetic tests for a range of health conditions from one’s susceptibility to developing heart disease to whether one will develop Huntington’s disease are available, and until recently, have only been at the discretion of clinicians. Beginning in 2007, private companies like the US based 23andMe and Navigenics created a new business model for genetic testing through the Internet. For a relatively small fee, consumers could purchase predictive probabilistic genetic tests online that are based on publicly available genome-wide associations studies. These genetic tests communicate whether you are at increased or decreased risk of developing certain conditions relative to the average person in the population. As consumers, we now have new degrees of freedom with which to flirt with our personal genetic ignorance. Consumer and labor advocates have worried about what implications these technologies might have for privacy, self-understanding, social welfare, and the medical profession. With genetic information flowing through non-traditional, non-clinical channels, employers and insurers could potentially access and use such information. In 2008 the Genetic Information Nondiscrimination Act (GINA) became federal law in the United States (see article below) •

ETHICAL DILEMMAS ON THE JOB

One reason might be when a potential employer is screening potential job applicants to see if they might be predisposed to adverse reactions to certain hazardous materials. An applicant, in order to get the job, may agree to such disclosure and also such testing is potentially beneficial to the applicant. Some provisions in GINA also allow an employer to conduct genetic monitoring of toxic substances in the workplace without the employee’s written authorization if the “genetic monitoring is required by federal or state law.” In such circumstances, GINA conditions such use only if: (a) the employer provides written notice of the genetic monitoring to the employee (b) the monitoring is in compliance with any federal or state genetic monitoring regulations, and (c) the employer, excluding any licensed health professional or board certified genetic counselor that is involved in the genetic monitoring program, receives the results of the monitoring only in aggregate terms that do not disclose the identity of specific employees; or where the employer conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of human remains identification and requests or requires genetic information is used for analysis or DNA identification markers for quality control to detect sample contamination.

PREVENTING DISCRIMINATION

Even under these circumstances, GINA prohibits discrimination by employers for who fail or refuse to hire or to discharge any employee or otherwise discriminate against any employee because of genetic information with respect to the employee. Thus, the law is very protective of employees. The difficulty in practice is for the employee to be able to prove that he or she was fired because of discrimination and not due to a documented performance issue. Also, employees who are terminated may not want to sue and may decide to just find a position elsewhere. Having a protective anti-discrimination law is good public policy, but enforcement and compliance are equally important. Also, just the fact that employers can have access to such information creates issues from a privacy and security perspective. GINA contains requirements as to how employers must maintain such genetic health information records. Furthermore, HIPAA (as amended by the HITECH Act) governs how employers must treat employee health records in the group health plan context.