The Sunshine Act Reporting Requirements For Medical Device Companies

Healthcare technology has grown and evolved over time. With the conversion to electronic medical records and the creation of social media just to name a few, ensuring patient privacy is of the utmost importance for healthcare facilities in this day and age. In order for an organization to avoid hefty fines, it is imperative that a healthcare administrator maintains compliance with the standards and regulations associated with the Health Insurance Portability and Accountability Act (HIPAA). This paper will provide a summary

Although the EHR is still in a transitional state, this major shift that electronic medical records are taking is bringing many concerns to the table. Two concerns at the top of the list are privacy and standardization issues. In 1996, U.S. Congress enacted a non-for-profit organization called Health Insurance Portability and Accountability Act (HIPAA). This law establishes national standards for privacy and security of health information. HIPAA deals with information standards, data integrity, confidentiality, accessing and handling your medical information. They also were designed to guarantee transferred information be protected from one facility to the next (Meridan, 2007). But even with the HIPAA privacy rules, they too have their shortcomings. HIPAA can’t fully safeguard the limitations of who’s accessible to your information. A short stay at your local

Modern communications capabilities open up a world of possibilities for all types of medical practices to develop deeper connections with their patients and to manage health care remotely. The HIPAA Privacy Rule gives patients the right to obtain copies of their medical records, treatments and protected health information or PHI. These requirements go further if medical providers want to receive reimbursement from Medicare and Medicaid -- patients must be able to access their records online, download copies and transmit the information to third-party providers. Most medical practices are finding it necessary to develop patient portals where patients and physicians can interact, share information and perform important functions such as practices billing patients and accepting payments online. HIPAA 's rules require that these patient portals have strong security and privacy protections to prevent unauthorized access of these confidential PHI records.

In most offices, and outpatient services has a team where the physician is unable to monitor the team at all times. For example, in a pharmacy setting there are pharmacists, pharmacy technicians, and clerks at times. The majority of the time the clerks have the most patient contact where the pharmacists are unable to monitor them at all times making sure protected health information is not spread. In the HIPAA rules, covered entities include health plans, health care clearinghouses, and health care professionals who electronically transmit any health information in connection with transactions for which HHS has adopted standards (Tomes, 2007). In writing, the people who are liable for violations are one those providers who bill electronically are covered entities. Directors or officers can commit violations by selling individually identifiable health information to a drug company for marketing purposes, they can also be charged if the director and or officer aided a covered entity’s commission of the HIPAA criminal act, and lastly can be heavily prosecuted if they commit identity theft utilizing patients protected health information (Tomes,

One technological change that may have the largest effect on our lives today is the rapid growth of medical technology development. Three main effects that medical technology has impacted our modern society are prolonging lifespan, improving quality of health care and promoting nation’s economic growth. The three stages of medical technology are review by regulatory agencies, technology assessments by insurance carriers, and review by purchasers, clinicians, and consumers. Review by regulatory agencies is the most recognized of the three stages and is administered by the Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health by regulating pharmaceutical products and medical devices. Each product must go through a series of approvals, clinical trials, and post market surveillance protocols in order to ensure its safety and effectiveness. www.nap.edu

The Health Insurance Portability and Accountability Act also known as HIPAA was first signed into law on the federal level in 1996. Since it was signed into law it has had a huge effect on patient’s privacy, healthcare workers and even insurance company’s. “HIPAA is intended to improve efficiency throughout health care and requires that health care providers adhere to standardized national privacy and confidentiality protections.” (OMA p .236). It’s an invaluable tool that has created a standard of compliance across the healthcare field.

During this research, there has been a collection of data that had been connected to the instances of HIPAA violations within the United States. There are various cases that have been reported through patients and employees where very personal medical information has been exposed unlawfully for personal gain. These cases have not only put a company at reputational risk. But these cases can also place a patient and or healthcare company in a terrible financial stipulation. This thesis will include a series of charts and tables that describe the fluctuation of such cases involving different examples of HIPAA violations. Not only will there be data of these instances but there will be illustrations of how both patients and healthcare employees exemplify HIPAA violations. These cases will be verified from an external and internal evaluation. Suggestive protocol will be demonstrated to guide one along to ensure the possibility of another case of HIPAA violation is prevented. Protocols and examples are being credited by diverse information.

The breach of patients’ confidential information does not only jeopardize our reputation and reduce the public trust in our organization, it could also lead to severe financial consequences. Under HIPAA law, if an organization is found guilty of unauthorized disclosure of patient medical record, they could face prison time harsh privacy violation penalty. We are sure that none of us want this to happen to our organization. So how can we prevent medical record security leak and better protect our patients’ privacy while also providing the best care possible to all our patients? The following guidelines and

Retrieved from http://www.marchofdimes.org/professionals/medical-resources.aspx). Office of the Medical Director and outside experts review all clinical information presented on the site (Marchofdimes.org, 2015). All the clinical material is based upon scientific research and the collective experience of practicing physicians and other health care providers (Marchofdimes.org, 2015). The “March of Dimes” regularly reviews all material to ensure that it is accurate, appropriate, and in accord with the leading important health professional organizations (Medical Resources | March of Dimes. (n.d.). Retrieved from http://www.marchofdimes.org/professionals/medical-resources.aspx). The privacy section explains how the “March of Dimes” collects personal information when you sign up with them by making a donation or creating an account (Marchofdimes.org, 2015). Personal information is only shared with consent, however, not shared for the purpose of companies to solicit the

The HIPAA Privacy Rule identifies the authentic need for public health specialists and others accountable for safeguarding public health and safety to have contact to secure health evidence to carry out their public health task. This rule identifies that public health reports made by protected persons are an imperative resource of recognizing dangers to the health and safety of the public as a whole, as well as persons. The rule also licenses protected objects to unveil threatened health material without approval for known public health devotions. To improve and uphold the public's health, deterrent programs and events are needed. The public health system emphases on prevention through population founded health advancement and public services

Medical technology encompasses a wide range of healthcare products and is used to diagnose, monitor, and treat diseases or medical conditions that affect humans. This may included but not limited too, pharmaceuticals, vaccines, and medical equipment. Such technologies are intended to improve the quality of healthcare delivered through earlier diagnosis, less invasive treatment options and reductions in hospital stays and rehabilitation times. Recent advances in medical technology have also focused on cost reduction. Medical technology may include medical devices, information technology, biotech, and healthcare services. The impacts of medical technology may involve social and ethical issues. For example physicians may seek objective information from technology rather than listening to subjective patient reports. A major contributor of healthcare expenditure in America is the advancement of medical technology. According to several studies it is shown that there is a correlation between the nation’s gross domestic product (GDP) and money allocated to healthcare. One of the leading theories is that medical technology is growing faster than expected.

Leadership in innovation in healthcare is no different, as its initiative is to progress while maintaining strict confidentiality and maintaining an overall safe and trustworthy establishment. Healthcare laws are issued to help safeguard patient information creating a moral medical healthcare environment. Healthcare laws secure patient information and medical history and it has helped against fraudulent practices such as identity theft. Knowledge and practice of such laws strengthen leadership. For example, HIPAA (The Health Insurance Portability and Accountability Act) privacy rule was created as a way to secure patient identifiable healthcare information and limiting its disclosures for legitimate purpose use only. To explain, the HIPAA Privacy Rule is an arrangement of selected models to secure the protection of patients' health records as these guidelines give patients access to their health record and control over how their own health record are utilized and disclosed (2015). In any event, the Privacy Rule addresses a guideline for understanding situations where disclosure can be given without patient consent. For example, court proceedings, insurance billing, and

The health care industry is one of the most dynamic and delicate industries in the U.S. having experienced healthy and substantial changes for the last thirty years most of which have aimed to improve health care management and services delivery to the patients. The changes have enabled the integration of technology into the industry such as in the area of informatics, science and research and payment services and clinical treatments. The health care sector has introduced various changes to address disease and health care management such as the Modernization Act of 2003, the Patient Protection Act and Affordable Act, which aim at improving health provision and most

“An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users.” (healthit.gov) The EHR mandate was created “to share information with other health care providers and organizations – such as laboratories, specialists, medical imaging facilities, pharmacies, emergency facilities, and school and workplace clinics – so they contain information from all clinicians involved in a patient’s care.” ("Providers & Professionals | HealthIT.gov", n.d., p. 1) The process has proved to be quite challenging for providers. As an

There are a multitude of patient privacy (HIPAA) and patient information concerns related to the use of technology in medical care. Selection of the proper hardware, operating systems and system software make the compliance with and documentation in support of these regulations far easier.