The Importance Of Medical Devices In Patients And Hospital Technology

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Ultimately, the software, equipment and cloud solutions the companies and vendors provide will have to demonstrate a high quality of security and reliability. Patients’ private medical data as well as their lives are at risk in this new arena of technology.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

These new guidelines will allow for a 12-year period of data exclusivity for new branded biologics. During the 12- year period, rivals are not allowed to use any prior data to try to come up with their own product. Before, the passage of the ACA, the Federal Drug Administration (FDA), could not legally approve new biologic medicines because they had to have clinical trials. This law opened up the regulatory guidelines for the FDA to approve

Securing larger volumes of data than before, health care providers must be able to adapt to new methods of data storage and access of patient records. Security breaches in health care organizations is lost or stolen from unencrypted devices and media where the provider is using to retrieve records. As more health providers continue to use mobile devices to access pertinent information from electronic medical records systems the chances for breach increases so dramatically. (Rogers,

Massive security breaches have run rampant throughout the healthcare industry, making EHR’s harder and harder to properly implement. With increased scrutiny and the stringent regulations surrounding the healthcare industry, protecting the healthcare information stored electronically is critical to the success of any future attempts at implementing healthcare electronic recording systems. The struggle lies in the fact that so many threats exist that any facility can be completely overwhelmed with the daunting task of securing information while attempting to implement new systems. Although Healthcare info has many threats such as human, technological, and natural threats, and it faces intense scrutiny due to the HIPAA regulation requirements, it is still possible to protect and secure it through physical, administrative, and technical safeguards.

Before any biopharmaceutical company can begin to manufacture a desired product, the company is required by law to establish an adequate facility to support a safe and efficient manufacturing process. The US Food and Drug Administration (FDA) department under the authority of the Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations (GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The fundamental purpose of the regulations beforehand is to accomplish a system that ensures products are consistently produced and controlled to the highest standards and thus prevent human safety risks that may not be reduced through testing the final

Data breaches have become common nowadays especially in the healthcare industry. For example, a number of hacking events have been reported in the past years (Croll, 2007). Such events in the healthcare industry, have threatened the safety of private medical records. Since the healthcare environment posses the most valuable information of patients, they are the establishments who are most likely to suffer from hackers. Most importantly, patients worry about their confidential data being safe and secure (Dimitropoulos, 2009). Now that hospitals are adapting new technologies and are leaving paper charts behind, EMR (electronic medical records) are on the rise. With EMR systems, there is need to

* No foreseeable new product in pipeline. Currently takes up to 11,000 compounds to be screened to find one (1) compound to send through final testing (human trials). And even then it’s not guaranteed to make it past the FDA.

Medical devices are another emerging cyber risk for CVS, particularly because many new devices connect to the internet. Medical device security does not end with the manufacturer, it is a shared responsibility between many partners that must find a balance between device operability and security. Interoperability is an important component to medical devices for CVS because it can yield savings by reducing adverse outcomes, redundant testing, and time spent assessing and entering patient information.

Numerous health care industries have been victims of cyber-attacks. Such attacks occur when an isolated device transfers the stored medical data to the hospital’s network, which could possibly takeover the entire network of the hospital and intercept data exchange between the patient and the healthcare center. For instance, wearable devices such as the (insulin) diabetes kit that determines the exact amount to be discharged into the patient’s blood, based on

It is critical now more than ever, due to the lack sufficient security, to protect patient data in the healthcare industry. Therefore, in order to accomplish this goal, investigation into the possible causes of inadequate security as well as the other causes of healthcare breaches and cyber-threats must be explored. Without this analysis, patient data will continue to be compromised, which will cause devastating damage to both patients and healthcare organizations. From the extensive research on the outbreak of healthcare data breaches, the major factors that contribute to the increase of this issue were discovered. By thorough analysis of these factors, useful solutions will be developed to decrease the compromise of patient data as well as healthcare organizations implementing better security measures.

This research article examines the security concerns of using mobile technology systems in health care institution. Various methods of ensuring privacy and security of patient’s electronic medical information are addressed. This high quality article is relevant for present day mobile security issues. The authors utilize a host of credible references in the health care and information technology fields.

In addition to the threats and vulnerabilities inherited with wired local area networks (LAN) there are many more risks associated with the use of wireless and mobile technologies. The use of laptops, smartphones, and tablets create vulnerabilities that can fall outside our network securities measure. Attackers will be able to bypass the firewalls and gain direct access to the doctor’s data. Once an intruder has access to the network the intruder will be able to launch denial of service