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

All healthcare providers, health organizations, and government health plans that use, store, maintain, or transmit patient health care information are required to comply with the privacy regulations of the HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) was passed by congress in 1996, and helps to ensure the privacy and security of Electronic Health Records (EHR's). By following the rules and regulations set forth under HIPAA, we can ensure the safety of patients' EHR's. We are responsible for protecting patients' records, and there are many measures we can take in order do this. Firstly, we must always keep patients' health information private. This means no discussing the records with people that are not authorized to know, and even then, we should only disclose the minimum necessary amount of information possible. For covered entities, we must designate a privacy and security officer to ensure the privacy

In 1996 president, Clinton signed an act called the Health Information Portability and accountability Act (HIPAA). HIPAA was put into action because many employers were denying health coverage for pre-existing conditions. The primary goal of the law is to make it easier for people to keep health insurance, protect the confidentiality and security of healthcare information and help the healthcare industry control administrative costs. Since 1996, HIPAA has a length timeline of new proposals and rules. Such as defining covered entities and authorized release of Protect health information (PHI). Since the initial act was since there have been many advancements in technology have made the government expand on the Act adding the Health Information Technology for Economic and Clinical Health (HITECH) act. This act was implemented for all health systems to move to electronic charting to minimize violations and security breaches.

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

In 2010, through President Barrack Obama’s advocacy, the United States enacted the Patient Protection and Affordable Care Act (“PPACA”) in an effort to ensure that all Americans have access to health coverage. As part of the PPACA Congress directed the Secretary of the U.S. Department of Health and Human Services (“HHS”) to develop and implement a Medicare Self –Referral Disclosure Protocol. The SRDP is intended to foster the resolution of potential or actual violations of Stark. This Section will give an in depth look at disclosures prior to SRDP, its enactment and the important developments in its brief existence.

Upon hearing the case on several violated privacy rules of HIPAA Act of 1996 by Cignet Health of Prince George’s County, MD (Cignet), the HHS Office for Civil Rights (OCR) found the accused guilty of breach of privacy. A civil money penalty (CMP) of $4.3 million was imposed on the company due to the violations identified by the Office of Civil Rights. This civil money penalty was the first one to be issued on any entity by the Department for violations of the HIPAA Privacy Rule. The amount of penalty imposed was determined by violation category and may increase if authorized by the HITECH Act section 13410(d). Cignet did not request a hearing when notified on the civil money penalty and therefore, its right to appeal against the imposed penalty is no longer viable.

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.

The marketing errors I chose to look at are related to Stark Law, and The Physician Payments Sunshine Act (PPSA). To better understand about the errors these physicians have made we need to better understand what Stark Law, and the Sunshine Act are. So first off I will give some back ground into what these Laws/Acts are.

Ten years ago after much challenges and questionable skepticism, the HIPAA policy became effective and has been shaping healthcare one regulatory policy at a time. The evolution of the HIPAA privacy act helped establish the HIPAA Security Rule which was published in 2003 and became effective in 2005, and then eventually led to the HIPAA Enforcement Rules and the Breach Notification Rule. With it joint fortification of the 2009 HITECH Act and HIPAA’s modifications to regulations, it was released in January 2013 to the industry (American Health Information Management Association, 2013).

Additionally, the penalties that were assessed within this case was based on the compliance of the policies and procedures of the HIPAA laws and was settled against Rite Aid by the rights of health information privacy. “Jill Granger and Laura Cataldo (2013) reports this standardization, originally suggested as a cost-saving measure by healthcare groups, eventually evolved to include federal protection of privacy with the introduction of the Privacy Rule, effective in 2001, for individually identifiable health information. This mandate established standards that dictated the use and disclosure of protected health information (PHI), and addressed issues such as administrative handling of information and the keeping of records, as well as the

The National Patient safety agency (NPSA) is an organization that created as a Special Health Authority. The function of this organization is to establish and managing patient in order to store maintain and secured semi-current records pending to their ultimate disposal. Besides that, the NPSA also assimilating safety-related information that can helps researcher to conduct research about healthcare. However, the security in accessing those records involves the authorization from the head of records agency that essential in protecting the patient records.

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

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.