Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and…Continue
Added by Roger Steven on November 23, 2017 at 6:17am — No Comments
Misuse of social media is a critical area of HIPAA privacy. A random act of carelessness by a healthcare worker can result in a Protected Health Information (PHI) breach, inviting actions from the HHS. As is known, protection of patient health information is what HIPAA is essentially all about. Many…Continue
Added by Roger Steven on November 14, 2017 at 6:29am — No Comments
The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.
The FWA must clearly outline the…Continue
Added by Roger Steven on November 13, 2017 at 5:45am — No Comments
While it is true that all researchers want their studies to be reviewed and approved quickly; it has to be borne in mind that risks in the study can slow the process. Evaluation of risks is a fundamental requirement as stated in DHHS and…Continue
Added by Roger Steven on October 31, 2017 at 6:36am — No Comments
Hypertension is the silent killer of our times. Over thirty million Americans -one eleventh of the entire country’s population -suffer from this condition. It is rightly termed the silent killer because not only does it not show obvious symptoms; it works silently against the system when it is present. Neglected hypertension is a sure cause for strokes and heart attacks.
There is a highly undesirable, but strong and almost irrefutable link between cardiovascular disease (CVD) and…Continue
Added by Roger Steven on October 27, 2017 at 7:20am — No Comments
In the dozen years from the time of its enactment, change in thinking has been one of the palpable aspects of HIPAA. The advising and counseling outlook that characterized the initial years of its existence is now history. HIPAA is today noted for its very stringent and arm-twisting attitude. Its methods of enforcement are dreaded, to put it mildly. The coaxing and wheedling method used by the Office of Civil Rights (OCR) is now passé. The OCR is extremely unrelenting in its expectations…Continue
Added by Roger Steven on October 25, 2017 at 7:15am — No Comments
A Physician Extender is one who is not a physician, but is of a lesser qualification, who helps physicians by carrying out many activities usually carried out by physicians. As the name suggests, Physician Extenders work to supplement the functions of a physician and could take a considerable load…Continue
Added by Roger Steven on October 18, 2017 at 6:48am — No Comments
As health information grows, sharing it among healthcare providers and researchers is necessary for providing and advancing healthcare services and healthcare research. But the Health Insurance Portability and Accountability Act (HIPAA) of 1996 severely limits how Protected Health Information (PHI) can be…Continue
Added by Roger Steven on October 13, 2017 at 7:44am — No Comments
In a scenario where today’s healthcare environment is fast paced, diverse and straddle many disciplines; retention and disposition of medical records -both paper and electronic -is fraught with complexities. There are different rules set out by the state agencies, as well as by HIPAA statutes and…Continue
Added by Roger Steven on October 11, 2017 at 7:19am — No Comments
Meeting the legal requirements required of a healthcare provider hinges on and depends directly on a clear grasp of HIPAA compliance requirements. A thorough grasp of HIPAA compliance entails being fully equipped with all the knowledge needed to put the proper policies and procedures in…Continue
Added by Roger Steven on October 9, 2017 at 7:44am — No Comments
A proper understanding of the Anti-Kickback Statute (AKS) is completely necessary for healthcare providers and professionals. It is among the strongest weapons in the government arsenal for enforcing the federal fraud and abuse laws. Along with Stark II (the federal physician anti-referral law),…Continue
Added by Roger Steven on October 5, 2017 at 7:04am — No Comments
The major reason for which there are widespread violations of the HIPAA Rules for communicating with patients by unencrypted email and text message is that healthcare providers and Covered Entities and their Business Associates are ignorant of the rules. Although the HIPAA Rules are pretty straightforward and easy to follow; providers and Business Associates who don’t implement them in accordance…Continue
Added by Roger Steven on October 3, 2017 at 6:03am — No Comments
With HIPAA now being fully enforced and the government getting stricter and stricter about its implementation; practice or business or compliance officers need to be absolutely thorough about all the areas of HIPAA implementation. Given that there are enormous issues of risks that Covered Entities and their Business Associates need to address; the need to be fully aware of the changes that the Omnibus Rule has brought…Continue
Added by Roger Steven on September 26, 2017 at 7:09am — No Comments
The introduction of the Electronic Health Record (EHR) has certainly brought about a major change in the way healthcare is administered in this vast country.
EHR's have evolved in a big way from the time they first came to be used in a moderate way in the healthcare industry a few decades ago. From then on, although the push towards making all health records online has been on -and the US economy saves close to $80 billion a year on paper and other aspects -the rate of penetration of…Continue
Added by Roger Steven on September 21, 2017 at 7:27am — No Comments
For people on a job hunt, the reason for not offering one is almost invariably the same: You lack experience. How do you convince the organization that one can gain no experience unless one has a job? This is a typical chicken and egg conundrum: You are not given a job because you have no…Continue
Added by Roger Steven on September 18, 2017 at 6:30am — No Comments
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a federal Act that regulates the manner in which physicians have to be paid when they treat patients who come to them under Medicare. It modifies and supersedes the earlier legislation on this topic, namely the Balanced Budget Act, which was in force from 1997.
From the time the Balanced Budget Act linked physician payments to budget cuts and economic growth; it has reduced physician payments by over a fifth. In…Continue
Added by Roger Steven on September 7, 2017 at 7:34am — No Comments
Ransomware is dangerous and malicious software that infects the operating systems of computers that are vulnerable. It blocks access to files, and demands a ransom for releasing it. After the ransom is paid, usually in the form of virtual cash, through means such as Bitcoin, the block may be released.…Continue
Added by Roger Steven on September 1, 2017 at 7:49am — No Comments
Protected Health Information (PHI) is a very valuable piece of information. It is valuable for the patient, for the healthcare provider, and for the insurer. Unfortunately, there is one source to which it is more valuable than to all these: Hackers. Protected Health Information is meant to be protected, but this information is coveted in the black market more than credit cards and social security.
The reason is simple: The PHI contains very vital, but confidential information about a…Continue
Added by Roger Steven on August 29, 2017 at 7:52am — No Comments
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), a federal Act that governs the way in which physicians need to be paid when they treat patients who come to them under Medicare, alters and replaces the earlier Act in this regard, namely the Balanced Budget Act, which was in force from 1997.
Since the Balanced Budget Act linked physician payments to budget cuts and economic growth; it brought down physician payments by 21 percent. MACRA, on the other hand, introduces…Continue
Added by Roger Steven on August 24, 2017 at 7:32am — No Comments
Perhaps no educational campus is free of students with some or another kind of mental or emotional issues. Considering the wide diversity of students that enroll into American colleges and the varied backgrounds they come from; it is no surprise that American colleges will have to deal with such…Continue
Added by Roger Steven on August 9, 2017 at 7:30am — No Comments